Prevention of incident SARS-CoV-2 infection through combined intranasal and intradermal administration of the GLS-5310 DNA vaccine during the Omicron outbreak

Prevention of incident SARS-CoV-2 infection through combined intranasal and intradermal administration of the GLS-5310 DNA vaccine during the Omicron outbreak | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Prevention of incident SARS-CoV-2 infection through combined intranasal and intradermal administration of the GLS-5310 DNA vaccine during the Omicron outbreak Joel Maslow, Javier Morales-Ramirez, Christine Roberts, Susan Spruill, and 9 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6406233/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted You are reading this latest preprint version Abstract We evaluated the safety and immunogenicity of boost vaccination with the GLS-5310 SARS-CoV-2 DNA vaccine to those previously vaccinated with the Ad26.S.CoV2, BNT162b2, or mRNA-1273 vaccines. GLS-5310 was administered intradermally (ID) and followed by application of suction using the GeneDerm device, or ID as well as intranasally (IN) by nasal atomizer. GLS-5310 vaccination was well tolerated. With respect to primary vaccine type, boost vaccination induced a 1.5- to 4-fold increase in antibody titers, up to a 14.4-fold increase in T cell responses by ELISpot. Incident SARS-CoV-2 infections, during a period of Omicron prevalence, were reported for 24.2% of participants: 1 of 17 (5.9%) vaccinated ID plus IN versus 16 of 53 (30.2%) vaccinated ID only, p = 0.042 (chi-square analysis). This first ever trial of a DNA vaccine administered IN plus ID showed potential protection against incident SARS-CoV-2 Omicron infection. NCT Clinical Trial number: NCT05182567 Health sciences/Medical research/Drug development Biological sciences/Drug discovery/Drug delivery Health sciences/Diseases/Infectious diseases/Viral infection Figures Figure 1 Figure 2 INTRODUCTION The severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) is the third highly pathogenic human coronavirus to emerge. Unlike SARS-CoV and the Middle East respiratory syndrome coronavirus (MERS-CoV), SARS-CoV-2 appears to be more highly adapted to upper respiratory tract infection. SARS-CoV-2 has had rapid genetic evolution, especially within the receptor binding domain (RBD) of the spike (S) protein, that has resulted in increased nasal affinity and greater transmissibility 1 , 2 . The Omicron lineage variants of SARS-CoV-2 were resistant to antibodies raised against earlier lineages, with each subsequent Omicron subvariant demonstrating increased escape against immune responses to earlier Omicron strains 3 . Booster vaccination against SARS-CoV-2 continues to be recommended since incident cases remain prevalent with new variants continuing to emerge. The protective efficacy of primary vaccination has been found to wane by 5 to 6 months 4 , 5 , while antibodies induced by mRNA booster vaccination begin to decline by 2 months and substantially wane after 4 months 6 , 7 . Heterologous combinations of primary and booster vaccines offer potential advantages including reduction of potential toxicities and reactogenicity of a particular vaccine type and the potential for greater breadth of T cell responses 8 . Development of intranasal (IN) vaccines against SARS-CoV-2 vaccines commenced early in the pandemic with numerous candidate vaccines being developed, of which at least two advanced to Phase 3 studies 9 – 12 . The reason for such interest is multifold asinitial nasal colonization and infection by SARS-CoV-2 is primarily via ciliated nasal mucosal cells which highly express both the angiotensin converting enzyme type 2 receptor (ACE2) and TMPRSS2, that serve as the cellular binding site for viral attachment and an accessory protein required for fusion and viral internalization, respectively 13 , 14 . Notably, ACE2 and TMPRSS2 expression increases with age suggesting increased susceptibility to SARS-CoV-2 infection in the elderly 15 . Also, systemically administered vaccines are considered as non-protective against viral transmission from mucosal spread 10 , 11 a fact supported by intramuscular vaccination of macaques studies showing that showed incomplete or poor nasal clearance of virus despite the lack of detectable virus in the lungs 16 – 18 . DNA vaccines, administered intranasally, have also been considered as a means to induce mucosal immunity 19 . Different formulations that have been assessed in preclinical studies include naked DNA 20 – 22 or DNA encapsulated into polymeric or liposomal nanoparticles 23 , 24 . Here we report the results of the CoV2-008 clinical trial which assessed the safety and immunogenicity of the GLS-5310 DNA vaccine against SARS-CoV-2 given as a boost to those previously vaccinated with either the BNT162b2, mRNA-1273, or the Ad26.S.CoV vaccines. GLS-5310 was administered either ID alone using the GeneDerm suction device or IN as well as ID. To our knowledge, this study represents the first clinical trial of a DNA vaccine administered intranasally. GLS-5310 was well tolerated by either route of administration and induced both humoral and cellular responses that persisted for a year post-vaccination. Moreover, study participants vaccinated both IN and ID with GLS-5310 reported a significantly lower rate of incident cases of SARS-CoV-2 infection relative to those vaccinated ID alone during a period of high transmissibility of SARS-CoV-2 Omicron variants. METHODS GLS-5310 vaccine The GLS-5310 vaccine, formulated from the pGO-1002 plasmid, has been described in detail elsewhere 25 . Briefly, the pGO-1002 plasmid encodes for the SARS-CoV-2 spike (S) and open reading frame 3a (ORF3a), with the S and ORF3a transgenes designed as consensus sequences of SARS-CoV-2 strains uploaded to GenBank through February 2020 25 . GLS-5310 at a concentration of 6 mg/ml was used for both ID and IN immunization. Toxicologic assessment of GLS-5310 administered IN and ID to New Zealand White Rabbits A 4-week repeated dose toxicology study of combined IN and ID GLS-5310 vaccine administration was performed at Biotoxtech Co., Ltd. (Cheongju-Si, Republic of Korea) under good laboratory practices (GLP). The study was reviewed and approved by the Institutional Animal Care and Use Committee (IACUC) of Biotoxtech (approval No. 200588). Animal care was in accordance with the Animal Protection Act of Korea and the Guide for the Care and Use of Laboratory Animals. Seventeen-week-old New Zealand white rabbits (NZWR) were vaccinated ID and IN with either GLS-0001 (SSC formulation buffer as placebo control) or 1.2 mg of GLS-5310 SARS-CoV-2 vaccine. A total of 16 male and 16 female rabbits were included with 8 of each sex administered placebo or vaccine. For ID vaccinations, animals were inoculated into a shaved and depilated region of back, after which suction was applied over the injection site using GeneDerm suction device (65 kPa, 30 sec). Animals were vaccinated twice with a two-week interval between vaccinations. Each ID inoculation consisted of two injections ID of 0.1 ml of either GLS-0001 or GLS-5310, the latter calculated to achieve a total ID dose of 1.2 mg. For IN vaccinations, animals were administered 0.2 ml of either GLS-0001 or GLS-5310 into one nostril using the MAD300 atomizer (Teleflex, Wayne, PA, USA) attached to a 3 ml syringe. Thus, GLS-5310 vaccinated animals received a total dose of 2.4 mg. Animals were monitored for clinical signs and symptoms and ophthalmologic examinations were performed at baseline and at 4-week intervals. Hematology and clinical chemistries to assess renal and hepatic function were obtained at baseline and just prior to necropsy. Five animals per sex per group were followed through to the final vaccination and then euthanized. Three animals per sex per group were followed for a 4-week recovery period. Following the 4-week recovery, animals were euthanized, and necropsy performed for gross and histologic evaluation of organs. Immunologic assessment of rabbits vaccinated ID and/or IN with GLS-5310 Female, New Zealand white rabbits were vaccinated twice at a 21-day interval. For each vaccination, animals were inoculated once with 200 µg of GLS-5310 in a volume of 0.1 mL or with 0.1 mL of SSC by ID injection into a shaved and then depilated region over the scapula using the Mantoux technique. Injections were then followed by application of suction using the GeneDerm device (65 kPa, 30 sec). For IN administration, 200 µg of vaccine in 0.1 mL of vaccine or 0.1 mL of SSC placebo were administered using the MAD300 atomizer (Teleflex) into one nostril. Serum was collected from each rabbit on days 1, 14, 21, 35, 56 and 77, and stored at -80°C until analysis. The study, performed under protocol 2788 − 0920, was approved by the University of Tennessee Institutional Animal Care and Use Committee For ELISA determinations, SARS-CoV-2 spike recombinant proteins were expressed with the Fc region of human IgG1 at the C-terminus (40591-V02H, Sino Biological, Chesterbrook PA) and used as the antigen for IgA and IgM assays while spike protein with a His-flag tag (RP-87671, Invitrogen, Waltham, MA) used as the antigen for IgG assays. Detecting antibodies were affinity purified, anti-rabbit Ig, class specific, HRP conjugates, obtained commercially (Bethyl Laboratories, Montgomery TX). To prepare each microtiter plate for ELISA, antigen diluted in phosphate buffered saline was added to each well and allowed to bind overnight at 4°C. Plates were washed three times with phosphate buffered saline (PBS) containing 0.05% tween (PBST). Serum was diluted in PBST, added to duplicate wells, and incubated at 37°C. Plates were washed and horse radish peroxidase (HRP) conjugated anti-class specific antibody diluted in PBST was added. Samples were incubated at 37°C and then washed. TMB substrate (N301, Pierce Biotechnology, Waltham, MA) was added and the reactions were stopped with 0.18 M sulfuric acid. Optical densities were determined at 450 nm on a plate reader. Values from blank wells that did not receive rabbit serum were subtracted from the optical density readings of all samples on the same plate. Study participants and procedures The CoV2-008 clinical trial was a randomized, open-label study to assess the safety and immunogenicity of the GLS-5310 DNA vaccine administered to those previously vaccinated against SARS-CoV-2 as a single booster of either ID alone or ID plus IN. Adult subjects, age 18 to 65 years old, who had completed a primary vaccination series with either the BNT162b2, mRNA-1273, or Ad26.CoV.S vaccine were enrolled. Receipt of a pre-study an mRNA booster vaccination was non-exclusionary if the most recent vaccination (booster or primary) was at least 5 months prior to enrollment. Those with symptoms of or known recent infection with SARS-CoV-2 were excluded, although distant infection was not an exclusion. Women of childbearing potential had pregnancy testing performed prior to vaccination. Pregnancy, or planned pregnancy during the study, and active breast feeding were exclusionary. The full list of inclusion and exclusion criteria are included in the protocol (supplementary material) and at ClinicalTrials.Gov (NCT05182567). The study was conducted at clinical sites in San Juan, Puerto Rico; Rockville, Maryland; and Lincoln, Nebraska. The study was reviewed and approved by the Institutional Review Board (IRB) at each study site. The study enrolled participants into one of four study arms to evaluate alternate delivery conditions for GLS-5310 boosters, each arm with three sub-strata based on the primary vaccinations received. Participants randomized to study arm 1 were administered GLS-5310 ID using a GeneDerm device programmed to deliver a suction pressure of 65 kPa for 30 sec (65 kPa/30 sec). Participants randomized to study arm 2 were vaccinated ID using the 65 kPa/30 sec GeneDerm device and were also vaccinated IN using the MAD300 atomizer. Participants randomized to study arm 3 were vaccinated ID using a 65 kPa/15 sec suction device, while participants randomized to study arm 4 were vaccinated ID using an 80 kPa/30 sec GeneDerm device. All participants received a dose of GLS-5310 vaccine of 1.2 mg ID; whereas for those in study arm 2, an additional 1.2 mg was administered IN. ID vaccinations were divided into two 0.6 mg doses and administered into the volar aspect of the forearm using the Mantoux technique with suction applied over the injection site immediately after each administration. IN vaccinations were performed using the MAD300 atomizer with the entire 1.2 mg administered to one nostril. Study visits occurred at baseline, 4 weeks post-booster vaccination, and then at 12, 24, and 48 weeks. Reviews of adverse reactions were conducted at each study visit, including any confirmed diagnosis of new COVID-19 infections. Laboratory assessments to include complete blood counts and serum chemistries were conducted at study visits prior to and following GLS-5310 vaccination. Serum and whole blood for peripheral blood mononuclear cells (PBMCs) were collected at the study visits to perform immunological assessments. Immunologic assessments for CoV2-008 study vaccinees Quantitative assessment of serum IgG antibodies against the SARS-CoV-2 spike protein were determined by enzyme linked immunosorbent assay (ELISA). Recombinant SARS-CoV-2 full length Spike protein (ACROBiosystems) was bound to solid phase 96-well microtiter plates overnight at 4°C. Plates were washed and blocked with milk diluent (SeraCare) then incubated with dilutions of serum from participants, in duplicate. IgG detection was performed with horseradish peroxidase enzyme-conjugated anti-human IgG (SeraCare) secondary reagent and KPL ABTS® Peroxidase Substrate (SeraCare). Optical density at 405 nm was measured on a standard microplate reader. Titers were calculated against the Frederick National Laboratory Serum COVID-NS01097, calibrated to the WHO international serology standard (20/136) and reported as binding antibody units per mL (BAU/mL). Quantitative assessment of serum and salivary IgA antibodies against the SARS-CoV-2 spike protein were determined by ELISA. Recombinant SARS-CoV-2 Spike protein (ACROBiosystems) was bound to solid phase 96-well microtiter plates overnight at 4⁰C. Plates were washed and blocked with milk diluent (SeraCare) then incubated with serum from participants, in duplicate. IgA detection was performed with horseradish peroxidase enzyme-conjugated anti-human IgA (SeraCare) secondary reagent and KPL ABTS® Peroxidase Substrate (SeraCare). Optical density at 405 nm was measured on a standard microplate reader. Titers were calculated against the Frederick National Laboratory Serum COVID-NS01097, calibrated to the WHO international serology standard (20/136) and reported as arbitrary units per mL (AU/mL) as no standardized units have been assigned specifically for the detection of IgA. Determination of T cell responses against the SARS-CoV-2 spike and ORF3a proteins was by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assay. Briefly, frozen PBMCs were thawed and rested overnight. Human IFN-γ ELISpotPRO (Mabtech) plates pre-coated with IFN-γ specific capture antibody were washed and blocked with media containing 10% FBS. Cells were stimulated for 18–24 hours with each of five pools of 15-mer peptides, overlapping by 11 amino acids, spanning the entire SARS-CoV Spike and ORF3A proteins (custom synthesis by GenScript). Secreted IFN-γ was detected with an alkaline phosphatase conjugated antibody and signal was developed using a BCIP/NBT-plus substrate. Spots were counted using a BioTek Cytation 7 plate reader and Gen5 3.11 software. Spot counts for each peptide pool were calculated as background-subtracted SFU/million PBMCs and results for each of the five peptide pools added to report a total SFU/million PBMCs. Statistics Statistical analysis of immune response and treatment failure (COVID infection) was performed on a modified intention-to-treat population which consisted of all participants who received booster treatment, regardless if they completed all follow up visits. Participants with both baseline and post-baseline samples for immune response were included in the summaries of immunogenicity. Participants were grouped into 2 categories of boosters, with or without IN component, ignoring primary vaccine. The proportion of infected participants in each group were compared using chi-square test. Ninety-five percent confidence interval of differences in proportions were computed using exact methods. Time to COVID infection was determined as the number of days from booster to the date of confirmed COVID infection. Those participants who completed all study visits without infection or who were lost to follow up were censored at the last known contact date. Survival distribution functions were calculated using procedure LIFETEST in SAS ( www.sas.com ) where the group differences in time to COVID infection are estimated using the product limit method (Kaplan-Meier method). Statistical significance of group differences in time to infection were evaluated using log-rank test. RESULTS Toxicologic assessment of GLS-5310 in NZWR The toxicology of GLS-5310 administered both IN and ID with the GeneDerm device was assessed in NZWR. GLS-5310 was well tolerated with no test article-related changes in physical signs, laboratory results, organ weights, organ appearance, or histopathology. Specifically, there was no of trauma on gross examination or histologic evidence of pathology at the ID site of vaccine administration, consistent with a previous toxicology study of ID administration of GLS-5310 26 . Examination of the nares of animals administered GLS-5310 IN showed no evidence of gross or microscopic signs of inflammation, with findings non-different from control animals. Concurrent IN and ID administration of GLS-5310 DNA vaccine in New Zealand White Rabbits induced high, IgG and IgA serum immune responses Animals tolerated vaccination well without evident systemic or administration site changes. Serum immune responses are shown in Figure S1 . ID vaccinated animals had high anti-spike IgG responses, which were highest for animals vaccinated both ID and IN, whereas animals vaccinated IN had minimal to no IgG antibodies detected (Figure S1 a). In contrast, marked anti-spike IgA responses were observed in the two groups of animals vaccinated IN (Figure S1 b). Notably, whereas animals vaccinated IN demonstrated rapid decay of serum IgA responses after day 21, those vaccinated both IN and ID had a higher magnitude, persistent response that was detectable through to study day 77. CoV2-008 clinical trial enrollment and demographics A total of 70 persons were enrolled into the CoV2-008 clinical trial with the first enrollment on 23 May 2022 and the last study visit on 07 July 2023. There were 34 persons enrolled at the San Juan, PR site ; 25 at Lincoln, NE; and 11 enrolled at Rockville, MD. Demographics of those participating in the study are shown in Table 1 . The average age of study participants was 43.4 years and 43 (61.4%) were female. With regard to race and ethnicity 55 (78.6%) were Caucasian, 13 (18.6%) were black or African American, 1 (1.4%) was Asian, and 36 (51.4%) were Hispanic or Latino. The average participant weight was 90.0 kg with a mean calculated body mass index (BMI) of 31.7 kg/m 2 , median of 31.2, and range from 16.6 to 54.1. Table 1 Demographics of participants in the CoV2-008 clinical trial Characteristic Study Arm 1 Study Arm 2 Study Arm 3 Study Arm 4 GeneDerm settings 65 kPa, 30 sec 65 kPa, 30 sec 65 kPa, 15 sec 80 kPa, 30 sec Intranasal vaccination No Yes No No Number in study arm 20 17 19 14 Age (years) Mean (SD) 45.7 (12.0) 37.6 (9.2) 43.2 (11.6) 47.3 (9.6) Median 47.0 36.0 46.0 46.5 Min, Max 26, 63 23, 54 22, 60 29, 65 Sex Female 12 (60%) 9 (52.9%) 12 (63.2%) 10 (71.4%) Male 8 (40%) 8 (47.1%) 7 (36.8%) 4 (29.6%) Race White 16 (80%) 14 (82.4%) 15 (78.9%) 10 (71.4%) Black, African American 3 (15.0%) 3 (17.6%) 4 (21.1%) 3 (21.4%) American Indian, Alaskan Native 0 0 0 1 (7.1%) Asian 1 (5.0%) 0 0 0 Native Hawaiian, Pacific Islander 0 0 0 0 Other 0 0 0 0 Ethnicity Hispanic or Latino 12 (60.0%) 8 (47.1%) 8 (42.1%) 8 (57.1%) Not Hispanic or Latino 8 (40.0%) 9 (52.9%) 11 (57.9%) 6 (42.9%) Height (cm) Mean (SD) 168.8 (10.0) 169.7 (10.2) 168.0 (8.8) 165.1 (7.3) Median 166.0 170.1 168.0 165.0 Min, Max 156, 190 146, 186 153, 189 152, 178 Weight (kg) Mean (SD) 79.4 (22.1) 99.1 (28.1) 93.7 (25.0) 89.3 (21.7) Median 76.40 91.2 86.70 86.45 Min, Max 44.0, 125.0 47.4, 161.9 66.0, 154.1 59.6, 136.0 BMI Mean (SD) 27.5 (5.7) 34.2 (8.7) 33.1 (8.1) 32.7 (7.8) Median 28.8 33.5 31.5 31.4 Min, Max 16.6, 36,6 20.8, 52.9 23.5, 54.1 22.4, 50.3 Study randomization is shown in Fig. 1. With regard to study-arm sub-strata, 23 participants received the BNT162b2 vaccine as their primary immunization series, 23 received the mRNA-1273 vaccine, and 24 received the Ad26.CoV.S vaccine. There were 8 participants who terminated the study prior to the final study visit, one each in study arms 1 and 2, four in study arm 3, and two in study arm 4. Reasons for early termination included lost to follow-up (n = 6), relocation out of region (n = 1), and voluntary withdrawal (n = 1). A total of 45 (64.3%) study participants received an mRNA booster, at least 5 months prior to GLS-5310 vaccination. For those who did not receive a booster vaccination, the mean (median, range, SD) of time from their first primary vaccination to when they received study vaccine was 399.4 days (405, 273–532, 67.8) and for those who received a booster vaccine the time from most recent vaccination to receipt of study vaccine was 211.9 days (211.5, 166–258, 24.6). A higher percentage of those who were vaccinated ID only had received a booster vaccination (37 of 53, 69.8%) versus those vaccinated IN plus ID (8 of 17, 47.1%; p = 0.5). In both the ID only and ID plus IN groups, days between pre-study vaccination to receipt of GLS-5310 were similar regardless of whether they had received an mRNA booster (mean of 211.5 days for those vaccinated ID only versus 217.5 days for those vaccinated ID plus IN) or had not received an mRNA booster (391.3 versus 405.0 days). Vaccine safety GLS-5310 vaccination was well tolerated, regardless of the route of administration or the GeneDerm device used. A total of 59 (84.3%) participants reported at least one treatment emergent adverse event (TEAE, Table 2 ). All TEAE were grade 1 or 2 and resolved spontaneously except for one participant in study arm 2 who was found to have a supraventricular dysrhythmia by initial ECG at the week 12 study visit and was diagnosed with a non-ischemic cardiomyopathy that was considered as non-study related by the investigator. Injection site reactions and general disorders were the most common reported AEs for 49 (70.0%) of participants that included injection site erythema for 26 (37.1%), asthenia for 16 (21.4%), and injection site pruritis 16 (21.4%), and injection site bruising for 12 (17.1%). Table 2 Treatment emergent adverse effects by System Organ Class by study arm Study Arm 1 Study Arm 2 Study Arm 3 Study Arm 4 GeneDerm pressure settings 65 kPa 30 sec 65 kPa 30 sec 65 kPa 15 sec 80 kPa 30 sec Intranasal vaccination No Yes No No Number in study arm 20 17 19 14 System organ class Participants with at least one TEAE 17 (86.0%) 16 (88.2%) 16 (78.9%) 12 (86.7%) General disorders, administration site conditions 14 (70.0%) 12 (70.6%) 12 (63.2%) 11 (78.6%) Nervous system disorders 8 (40.0%) 7 (41.2%) 6 (31.6%) 8 (67.1%) Infections and infestations * 7 (35.%) 2 (11.8%) 9 (47.4%) 6 (35.7%) Musculoskeletal and connective tissue disorders 3 (15.0%) 6 (35.3%) 4 (21.1%) 6 (42.9%) Respiratory, thoracic and mediastinal disorders 2 (10.0%) 6 (36.3%) 1 (6.3%) 1 (7.1%) Gastrointestinal disorders 1 (6.0%) 3 (17.6%) 1 (6.3%) 1 (7.1%) Psychiatric disorders 2 (10.0%) 0 1 (6.3%) 0 Cardiac disorders 0 1 (6.9%) 0 0 Immune system disorders 1 (6.0%) 0 0 0 Injury, poisoning, procedural complications 1 (6.0%) 0 0 0 Pregnancy 0 0 1 (6.3%) 0 Reproductive system and breast disorders 0 0 1 (6.3%) 0 Skin and subcutaneous tissue disorders 1 (6.0%) 0 0 0 * Infections and infestations are inclusive of COVID-19 infections Respiratory and thoracic complaints were reported for 10 (14.3%) of participants and was more common for those who also received GLS-5310 nasally: 6 (36.3%) of 17 vaccinated IN plus ID versus 4 (7.5%) vaccinated ID only. Specific complaints of those vaccinated with GLS-5310 IN plus ID relative to ID only included rhinorrhea in 3 (17.6%) versus 2 (3.8%), nasal congestion in 2 (11.8%) versus 1 (1.9%), cough 2 (11.8%) versus none, and wheezing in 2 (11.8%) versus none. Epistaxis was reported for 1 (6.9%) person vaccinated IN plus ID versus none vaccinated ID only. Other reported AEs were not different bewteen study arms except for a lower rate of infections and infestations for those vaccinated both ID and IN that is addressed below. Immune responses following booster vaccination with GLS-5310 Since primary vaccination type has been shown to be a determinate of antibody responses post boost vaccination 27 , we examined immune responses for each primary vaccine type regardless of study arm and for each sub-group within the four study arms (Table 3 a). Consistent with other studies 27 , baseline titers were higher for those initially vaccinated with an mRNA vaccine versus an adenoviral vaccine (Table 3 a). The largest increase of anti-spike IgG titers post-boost were observed for those originally vaccinated with the Ad26.CoV.S vaccine, of approximately 3- to 4-fold (Table 3 b). For those who were initially vaccinated with an mRNA vaccine, post-boost increases were in general in the 1.5- to 1.7-fold range, although those in study arm 1 who were vaccinated initially with mRNA-1273 had a 2.85 increase in titers 2-weeks post-vaccination. Of interest, for many sub-groups, peak IgG responses were observed at week 12 post-vaccination (Table 3 b), consistent with a prior Phase 1 study of GLS-5310 administered with GeneDerm to vaccine-naïve recipients 28 , although the small sample size in this study precludes definitive conclusions. Table 3 a: Spike ELISA relative to study arm and primary vaccine type Arm 1 GLS-5310 ID GeneDerm 65kPa/30s Arm 2 GLS-5310 ID + IN GeneDerm 65kPa/30s Arm 3 GLS-5310 ID GeneDerm 65kPa/15s Arm 4 GLS-5310 ID GeneDerm 80kPa/30s Primary vaccine AD26CoVS N = 7 mRNA1273 N = 6 BNT162b2 N = 7 AD26CoVS N = 6 mRNA1273 N = 6 BNT162b2 N = 5 AD26CoVS N = 6 mRNA1273 N = 6 BNT162b2 N = 7 AD26CoVS N = 4 mRNA1273 N = 5 BNT162b2 N = 5 Baseline gmt 9422.01 17168.97 16516.46 15055.09 16259.44 15585.28 6538.61 17765.37 13623.86 4302.58 7884.13 6811.38 95CI H 30448.11 50663.10 37530.30 46235.83 51836.04 36990.10 27751.72 61379.32 35861.74 38967.78 17544.96 56033.89 95CI L 2915.60 5818.31 7268.62 4902.17 5100.11 6566.64 1540.57 5141.93 5175.70 475.06 3542.87 827.98 Wk02 gmt 12256.61 48884.84 16321.10 13102.89 11418.40 16591.20 8890.20 19153.32 13907.17 4094.14 13840.81 4898.46 95CI H 30772.15 96189.07 68109.61 33588.92 38422.44 57766.25 41866.13 94506.41 32734.96 25827.22 66600.39 36157.43 95CI L 4881.83 24844.06 3911.02 5111.38 3393.32 4765.20 1887.82 3881.74 5908.35 649.01 2876.38 663.62 Wk04 gmt 7033.68 25819.65 15950.51 14901.77 10926.41 15882.19 8235.65 17392.56 9968.65 3612.79 9530.61 10098.41 95CI H 16885.80 64127.66 38011.37 52412.73 41788.90 49366.33 38558.42 64605.46 20295.91 24197.32 33878.65 90198.85 95CI L 2929.84 10395.73 6693.23 4236.81 2856.90 5109.64 1759.04 4682.28 4896.26 539.41 2681.11 1130.59 Wk12 gmt 15569.13 15627.38 22360.87 27716.57 14622.34 14483.53 28915.03 26692.71 20791.58 11444.24 11348.89 7603.47 95CI H 59570.28 38356.95 39769.62 2124084.21 69851.53 31012.96 92230.86 78199.56 77868.65 36791.34 46832.90 39177.83 95CI L 4069.11 6366.90 12572.63 361.67 3060.96 6764.03 9065.07 9111.32 5551.53 3559.82 2750.14 1475.65 Wk24 gmt 18577.77 14790.67 17718.52 14338.01 12511.58 18751.48 30451.63 27537.90 17091.01 7142.19 9561.92 7943.62 95CI H 77123.82 27426.36 42844.69 71455.29 35663.03 63357.26 137470.49 56545.31 27315.15 101385.27 34870.81 1409352.43 95CI L 4475.06 7976.41 7327.54 2877.02 4389.41 5549.77 6745.46 13411.12 10693.80 503.14 2621.97 44.77 Wk48 gmt 31931.64 25950.17 12715.54 15185.66 14393.22 16162.88 11643.64 24114.39 17669.03 13042.33 12219.41 9489.55 95CI H 80759.90 47631.33 50623.23 48405.46 36802.54 63722.49 34323.12 108379.02 55365.31 37554.37 79651.57 89397.58 95CI L 12625.44 14138.00 3193.89 4764.01 5629.09 4099.63 3949.94 5365.46 5638.81 4529.49 1874.59 1007.32 Data are reported as geometric mean titers (GMT) in international units (IU)/ml against the SARS-CoV-2 ancestral spike antigen. Table 3 b: Fold change in spike ELISA relative to baseline relative to study arm and primary vaccine type Arm 1 GLS-5310 ID GeneDerm 65kPa/30s Arm 2 GLS-5310 ID + IN GeneDerm 65kPa/30s Arm 3 GLS-5310 ID GeneDerm 65kPa/15s Arm 4 GLS-5310 ID GeneDerm 80kPa/30s AD26CoVS mRNA1273 BNT162b2 AD26CoVS mRNA1273 BNT162b2 AD26CoVS mRNA1273 BNT162b2 AD26CoVS mRNA1273 BNT162b2 Wk02 1.301 2.847 0.988 0.870 0.702 1.065 1.360 1.078 1.021 0.952 1.756 0.719 Wk04 0.747 1.504 0.966 0.990 0.672 1.019 1.260 0.979 0.732 0.840 1.209 1.483 Wk12 1.652 0.910 1.354 1.841 0.899 0.929 4.422 1.503 1.526 2.660 1.439 1.116 Wk24 1.972 0.861 1.073 0.952 0.769 1.203 4.657 1.550 1.254 1.660 1.213 1.166 Wk48 3.389 1.511 0.770 1.009 0.885 1.037 1.781 1.357 1.297 3.031 1.550 1.393 Anti-spike IgG antibody responses by study arm are shown in Figure S2 a. Antibody responses are seen to be non-different regardless of which GeneDerm setting (65 kPa/15 seconds, 65 kPa/30 seconds, or 80 kPa/30 seconds) was used for ID delivery of GLS-5310. With regards to post-boost T cell responses, increases relative to baseline were evident relative to primary vaccine type (Table 4 a). In general, the largest increases in T cell response were observed for those previously vaccinated with an mRNA vaccine and ranged as high as 14.4-fold above baseline (Table 4 b). While small increases in T cell responses were observed starting at 4 weeks post-boost vaccination, T cell responses typically peaked at either 12 or 24 weeks post-boost and persisted at elevated levels through 48 weeks (Table 4 a), which was similarly consistent with our Phase 1 study in vaccine-naïve recipients 28 . Table 4 a. T Cell Immune response by study arm and relative to primary COVID-19 vaccine type Arm 1 GLS-5310 ID GeneDerm 65kPa/30s Arm 2 GLS-5310 ID + IN GeneDerm 65kPa/30s Arm 3 GLS-5310 ID GeneDerm 65kPa/15s Arm 4 GLS-5310 ID GeneDerm 80kPa/30s Primary vaccine AD26CoVS N = 7 mRNA1273 N = 6 BNT162b2 N = 7 AD26CoVS N = 6 mRNA1273 N = 6 BNT162b2 N = 5 AD26CoVS N = 6 mRNA1273 N = 6 BNT162b2 N = 7 AD26CoVS N = 4 mRNA1273 N = 5 BNT162b2 N = 5 Baseline gmt 365 301.95 251.43 146.67 121.95 79.17 394.76 101.95 393.09 478.00 110.33 380.00 95CI H 877.50 671.77 548.65 333.75 230.47 136.98 893.93 185.27 967.57 1258.89 260.91 984.72 95CI L -147.50 -67.88 -45.79 -40.41 13.42 21.35 -104.41 18.62 -181.38 -302.89 -40.25 -224.71 Wk04 gmt 791.43 108.89 145.83 224.00 151.39 156.95 336.43 289.45 593.61 603.00 111.33 150.83 95CI H 1966.47 187.42 349.63 628.97 420.05 402.59 751.57 656.21 1739.03 1639.97 281.01 441.94 95CI L -383.61 30.36 -57.96 -180.97 -117.27 -88.70 -78.71 -77.32 -551.81 -433.97 -58.34 -140.27 Wk12 gmt 2411.43 181.25 76.25 131.25 180.42 131.67 282.92 253.33 787.92 562.50 92.50 156.88 95CI H 5692.48 411.84 154.48 363.67 501.68 364.62 469.00 511.53 2429.64 1481.34 261.20 491.32 95CI L -869.62 -49.34 -1.98 -101.17 -140.85 -101.28 96.83 -4.86 -853.80 -356.34 -76.20 -177.57 Wk24 gmt 2000.36 181.25 152.50 417.00 147.08 104.17 277.00 320.00 1306.25 814.50 160.50 1191.67 95CI H 5098.45 411.84 265.10 1149.50 327.62 152.51 572.53 508.82 3200.66 2110.88 422.42 4038.77 95CI L -1097.74 -49.34 39.90 -315.50 -33.46 55.83 -18.53 131.18 -588.16 -481.88 -101.42 -1655.44 Wk48 gmt 1597.5 932.50 100.42 450.00 111.25 750.42 347.00 602.50 692.00 1765.00 74.00 1135.83 95CI H 3964.33 2670.62 214.13 1257.47 184.50 2428.26 672.57 1275.06 1628.59 5258.38 135.37 2352.88 95CI L -769.33 -805.62 -13.30 -357.47 38.00 -927.42 21.43 -70.06 -244.59 -1728.38 12.63 -81.21 Data are reported as total SFU/10 6 PBMCs as determined by ELISpot Table 4 b. T cell immune responses – fold rise from baseline Arm 1 GLS-5310 ID GeneDerm 65kPa/30s Arm 2 GLS-5310 ID + IN GeneDerm 65kPa/30s Arm 3 GLS-5310 ID GeneDerm 65kPa/15s Arm 4 GLS-5310 ID GeneDerm 80kPa/30s AD26CoVS mRNA1273 BNT162b2 AD26CoVS mRNA1273 BNT162b2 AD26CoVS mRNA1273 BNT162b2 AD26CoVS mRNA1273 BNT162b2 Wk04 1.552 1.063 0.643 1.279 0.809 5.776 0.762 5.375 4.535 1.195 0.988 0.551 Wk12 2.065 1.748 1.270 1.070 1.919 4.661 1.163 4.741 1.545 0.588 0.595 0.594 Wk24 3.430 1.331 2.444 4.385 1.040 10.468 0.721 4.014 10.078 2.440 1.311 2.631 Wk48 2.647 3.367 0.577 2.345 1.034 14.443 1.181 5.446 1.644 2.024 0.460 3.250 T cell responses for each study arm are shown in Figure S2 b with a broad-based increase from baseline. As was observed for the binding antibody response, there was no apparent difference related to route of vaccine administration or GeneDerm setting. Serum and salivary IgA responses were compared for Arm 1 versus Arm 2 participants, who were vaccinated ID using the 65 kPa/30 and differed as to vaccination ID only versus ID plus IN, respectively. Saliva was collected at baseline, and at study visits at week 2, 4, and 12. Anti-spike IgA levels were not significantly different between baseline and later time points for either the ID or ID plus IN group (data not shown). Potential protective effect against SARS-CoV-2 infection from ID plus IN vaccination with GLS-5310 A total of 17 persons in the CoV2-008 clinical trial reported incident confirmed SARS-CoV-2 infection during the study. The first reported infection occurred on study day 16 and the last on study day 250. All of the infections were self-limited, not requiring hospitalization. Only 1 (5.9%) of 17 participants who were vaccinated IN and ID reported SARS-CoV-2 infection (67.2 per 1000 person years, 95% CI 52.8 to 85.1) versus 16 (30.2%) of the 53 participants vaccinated ID only (450.9 per 1000 person years, 95% CI 410.3 to 493.6). This represented a 24.3% difference in proportion of infections which was statistically significant (p = 0.042. 95% CI: 14.7%, 36.0%). Kaplan-Meier estimate of time to SARS-CoV-2 infection is shown in Fig. 2 demonstrating significant divergence between the two groups (p = 0.047) with a calculated efficacy of 80.46% for the combination of ID and IN vaccination relative to ID vaccination alone. Since neither group reached 50% infection rate, median time to infection and the difference in median time to infections could not be calculated. Although nasal swabs for SARS-CoV-2 genotyping were not collected post-infection, wastewater surveillance as reported by the Centers for Disease Prevention and State level Departments of Health for each geographic region 29 – 31 was examined as an indirect measure of temporal genotype prevalence. Table 5 shows the regional strain prevalence of SARS-CoV-2 variants circulating at the time that each infection was reported. Notably, as the study was conducted between May 2022 to late January 2023, only Omicron and Omicron subvariants were prevalent, although specific strains differed regionally and temporally. Table 5 Prevalence of SARS-CoV-2 variants at the time of each infection relative to geographic location of reported infection # Study arm Infection Date Site BA1 BA1.1 BA2 BA2.9 BA2.12 BA2.12.1 BA2.75 BA4 BA4.6 BA5 BA5.1 BA5.2 BA5.2.1 XBB1.5 BQ1 1 4 10-Jun-22 PR 14.2 4.1 49.2 13.9 5.9 4.7 4.3 2 1 22-Jun-22 PR 14.2 4.1 49.2 13.9 5.9 4.7 4.3 3 3 1-Jul-22 PR 13.5 18.3 5.9 24.1 18.0 6.4 12.3 4 4 12-Jul-22 PR 13.5 18.3 5.9 24.1 18.0 6.4 12.3 5 3 14-Jul-22 PR 13.5 18.3 5.9 24.1 18.0 6.4 12.3 6 4 15-Jul-22 MD 2.8 12.2 3.4 9.1 65.8 3.2 7 2 23-Jul-22 PR 13.5 18.3 5.9 24.1 18.0 6.4 12.3 8 3 5-Aug-22 MD 6.2 29.1 52.0 10.5 9 1 8-Aug-22 PR 8.3 8.5 21.5 21.3 7.8 30.9 10 1 11-Aug-22 PR 8.3 8.5 21.5 21.3 7.8 30.9 11 3 17-Aug-22 MD 2.3 95.6 12 4 18-Aug-22 PR 8.3 8.5 21.5 21.3 7.8 30.9 13 3 7-Oct-22 MD 99.8 14 1 18-Nov-22 NE 1.0 4.0 2.0 3.0 63.0 27.0 15 3 9-Dec-22 NE 1.9 5.0 1.9 41.0 50.0 16 1 11-Dec-22 NE 1.9 5.0 1.9 41.0 50.0 17 1 26-Jan-23 PR 33.8 66.2 Strain prevalence in Nebraska, Puerto Rico, and Maryland was estimated from data published by the local health departments or CDC 29 – 31 . Presented are variants that constituted ≥ 1% of circulating strains. Study arms are as shown in Fig. 1; participants in study arm 2 were also administered GLS-5310 IN. Assessment of potential factors that may have explained the lower incidence of SARS-CoV-2 incident infections in the ID plus IN group, other than vaccination administration route, was then examined. We first examined whether the rates of pre-study mRNA booster vaccination differed between the ID only and the ID plus IN groups, since this may afford protection against future infection. However, as noted above, a greater fraction of participants vaccinated ID only had received a pre-study mRNA booster vaccine compared to those in the ID plus IN group. We next considered whether primary vaccine type was a factor between treatment type, and found that the fraction who reported infection versus those who did not was not different (data not shown). Geographically, while fewer infections were reported for the Nebraska site relative to either Puerto Rico or Maryland sites (12.0%, versus 29.4% and 36.4% of participants, respectively), there was no apparent association that could explain a difference in infection rates. Finally, considering that there were 8 participants who discontinued the study prior to the final scheduled study visit, we examined whether unreported infections could have potentially affected the difference between groups. As shown in Fig. 2, only one person in ID plus IN group (study arm 2) terminated the study and did so late in clinical trial on day 328 just prior to the final study visit, whereas the other 7 persons who terminated early were in ID only groups and stopped participation at different time points throughout the study. Thus, if there were unaccounted SARS-CoV-2 infections, they would have had a greater likelihood of occurring in the ID only group and would have increased, not decreased, the difference between groups. DISCUSSION We report here on the safety, toxicology, immunogenicity, and efficacy of the GLS-5310 DNA vaccine administered both ID with GeneDerm and ID plus IN to those previously vaccinated with either an mRNA or Ad26 vaccine against SARS-CoV-2. The CoV2-008 clinical trial represents the third study of the GLS-5310 vaccine and the first study that investigated the use of a DNA vaccine as part of a heterologous boost regimen. The study also represents, to our knowledge, the first use of a DNA vaccine administered IN to humans. This study complements our prior study that reported on GLS-5310 vaccination was later followed by mRNA booster vaccination which was well tolerated and immunogenic 32 . As in prior Phase 1 study of GLS-5310 given to vaccine-naïve participants 28 , we find that GLS-5310 administered as a booster to those previously vaccinated with either an mRNA or Ad26 vaccine against SARS-CoV-2 was well tolerated. Those vaccinated IN reported a greater incidence of low-grade upper respiratory adverse reactions, but otherwise was tolerated without difficulty. Additionally, use of a GeneDerm device that applied a higher suction pressure of 80 kPa was tolerated equally well to use of a GeneDerm device that delivered 65 kPa of suction pressure, consistent with our prior pre-clinical experience ( 33 and unpublished data). Safety of concurrent IN and ID administration of GLS-5310 was confirmed as part of a repeated dose GLP toxicology study that found no test article related toxicity that yielded results similar to a prior study that assessed GLS-5310 administered ID only to NZWR 26 . In separate pre-clinical experiments in NZWR, GLS-5310 when administered IN induced high levels of serum IgA in rabbits, with concurrent IN and ID vaccination yielding higher IgA and more persistent responses relative to IN vaccination alone. Serum IgG responses were similar between ID and IN plus ID vaccinated groups, and essentially non-detectable for animals vaccinated IN alone, the latter as reported by others 34 , 35 . Importantly, these studies found that IN administration with a DNA vaccine protected animals from nasal challenge with influenza and gastrointestinal challenge from rotavirus 34 , 35 . GLS-5310 administered as a single booster was immunogenic inducing 1.5- to 4-fold increases in serum IgG titers and up to 14.4-fold increases in T cell responses by ELISpot. Notably, both antibody and T cell responses typically remained elevated throughout the 48-week final study. We observed no difference in immune responses relative to route of vaccine administration (ID only versus ID plus IN) or with use of GeneDerm devices with various pressure settings (65 kPa versus 80 kPa) or time that suction was delivered (15 versus 30 seconds). Consistent with other studies 27 , study participants who had been previously vaccinated with a primary mRNA vaccine series had higher baseline antibody titers but a smaller increase in post-vaccination titers relative those who had been vaccinated with the Ad26.CoV.S vaccine. Notably, the high post-vaccination T cell responses that we observed were greater than the 2 to 3-fold post-vaccination increase seen for other heterologous primary series – boost vaccine combinations 36 . Importantly, both B and T cell increases were persistent, a beneficial effect for potential long-term protection. Importantly, the combination of IN and ID vaccination appeared to be protective against incident SARS-CoV-2 infection as only 1 (5.9%) of the 17 participants who were vaccinated IN plus ID reported infections versus 16 (30.2%) of the 53 participants vaccinated ID only, p = 0.042 by chi-square analysis, with a calculated vaccine efficacy of 80.5%. Separation between groups was detectable within 2 weeks post-boost vaccination. The majority of infections occurred within 180 days of vaccination with GLS-5310 and only one additional infection at study day 230 days implying protection for at least 6 months and potentially for almost 8 months. However, we were unable to demonstrate any immunologic differences between groups, including attempts to document differences in IgA responses. The apparent protection against incident SARS-CoV-2 infection was even more notable considering that the clinical trial was conducted between May 2022 and July 2023 when Omicron variants of concern (VOC) had replaced earlier, vaccine susceptible strains 29 – 31 . During this time, variant strain emergence was clearly dynamic as multiple Omicron strains were circulating at each clinical site at varied over time. The observed protection against a variety of Omicron VOC is notable since GLS-5310 vaccine was designed based on a consensus of ancestral strains circulating early in the pandemic 25 . To our knowledge, this is the first clinical trial that has shown potential protection from a nasal vaccine against incident SARS-CoV-2 infection due to Omicron VOC strains. A Phase 3 study of the dNS1-RBD vaccine, created by inserting the codon-optimized coding region of the receptor binding domain (RBD) of Wuhan strain SARS-CoV-2 into an NS1 deleted influenza to create a live-attenuated nasal vaccine 37 , in vaccine-naïve, previously uninfected individuals conducted during a time when Omicron VOCs were circulating yielded a vaccine efficacy against symptomatic infection of 28.2% (95% CI 3.4–46.6) 38 . A second, Phase 1, study also during a period when Omicron VOCs were prevalent evaluated the safety and immunogenicity of the ChAdOx1 nCoV19 viral-vectored vaccine given IN included a small booster substudy for which vaccine was administered to those previously vaccinated with either the ChAdOx1 (n = 6) or the BNT162b2 mRNA (n = 6) vaccines 39 . During the approximate 4-month follow-up period, 4 (33.3%) persons in the substudy, including 1 in the ChAdOx1 group and 3 in the BNT162b2 group developed incident SARS-CoV-2 infection. A third clinical trial also performed during the Omicron outbreak, a Phase 3 study of the BBV154 Ad26 vaccine given as an IN booster to those who previously received two doses of BBV154 reported safety data but had not yet completed efficacy analysis at the time of the preliminary publication 40 . By comparison, protective efficacy of mRNA IM boost vaccination against Omicron infection appears to be high initially but rapidly wanes. A study based on reported rates of infection within the US Veterans Affairs system calculated vaccine efficacy of 87% within the first two months post-boost that decreased to 66% by five months 41 . And a large Israeli study reported vaccine efficacy of 53.4% within the month after boost vaccination that declined to 16.5% by three months 7 while a fourth dose (or second booster) was reported with a vaccine efficacy of 52% within the five weeks post-vaccination that declined to -2% at 15 to 26 weeks 42 . Whether the apparent protection in our study was B or T cell related is unknown. Others have shown that among those with incident SARS-CoV-2 infection, lower nasal viral loads and more rapid viral clearance are correlated with greater systemic T cell responses 43 . Notably, T cell immunity was observed at the time of SARS-CoV-2 infection diagnosis, i.e. within days of exposure 43 . Moreover, the same group demonstrated the formation of nasal mucosal tissue resident memory T cells and memory B cells and germinal centers among those with repeat SARS-CoV-2 exposure 44 . Whether nasal vaccination in our study would thus induce protective local T cell responses is as yet unknown and of interest not only for SARS-CoV-2, but any viral pathogen for which the upper airway is the site of initial colonization and infection. While results in this study showed apparent protection against incident SARS-CoV-2 infection, the study has a number of limitations. First and foremost, the results showing protection afforded by the combination of IN plus ID vaccination represent an ad-hoc analysis of the CoV2-008 clinical trial was not designed to assess the protective efficacy of IN vaccination with GLS-5310 and the small sample size of 70 persons limits generalization. Second, we were unable to detect group or sub-group differences in immune responses that correlated the apparent clinical difference. Also, while IN plus ID vaccination appeared to be protective against symptomatic infection from a multiplicity of Omicron variants, this observation is predicated on reported prevalences of circulating variants based on reports of wastewater studies 29 – 31 and could not be confirmed since infecting isolates were not genotyped. Finally, it is possible that additional cases of Omicron variant infection occurred but were completely asymptomatic, and therefore never diagnosed as the rate of asymptomatic infection related to Omicron has been reported to range between 25 and 32% in two meta-analyses 45 , 46 while a South African vaccine study among HIV positive individuals found that 23% of enrollees had asymptomatic infection detected by nasal swab at enrollment 47 . In conclusion, we have shown further evidence of the safety and immunogenicity of the GLS-5310 DNA vaccine against SARS-CoV-2 when administered ID using the GeneDerm suction device. Post-boost responses were consistent with other studies of heterologous vaccine regimens and importantly we found that immune responses were persistent as we have previously reported in vaccine-naïve participants 28 . Further, we found that IN administration of the GLS-5310 vaccine was safe and may have been effective in preventing incident SARS-CoV-2 infection. 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Nasal immunization of mice with a rotavirus DNA vaccine that induces protective intestinal IgA antibodies. Vaccine 2004 23(4): 489–98. Torrieri-Dramard L, Lambrecht B, Ferreira HL, Van den Berg T, Klatzmann D, Bellier B. Intranasal DNA vaccination induces potent mucosal and systemic immune responses and cross-protective immunity against influenza viruses. Mol Ther 2011 19 (3): 602–11. Munro APS, Janani L, Cornelius V, et al. Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial. Lancet 2021; 398(10318): 2258–76. Chen J, Wang P, Yuan L, et al. A live attenuated virus-based intranasal COVID-19 vaccine provides rapid, prolonged, and broad protection against SARS-CoV-2. Sci Bull (Beijing) 2022 67(13): 1372–87. Zhu F, Huang S, Liu X, et al. Safety and efficacy of the intranasal spray SARS-CoV-2 vaccine dNS1-RBD: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med 2023 11(12): 1075–88. Madhavan M, Ritchie AJ, Aboagye J, et al. Tolerability and immunogenicity of an intranasally-administered adenovirus-vectored COVID-19 vaccine: An open-label partially-randomised ascending dose phase I trial. EBioMedicine 2022 85:104298. Singh C, Verma S, Reddy P, et al. Phase III Pivotal comparative clinical trial of intranasal (iNCOVACC) and intramuscular COVID 19 vaccine (Covaxin®). NPJ Vaccines 2023 8(1):125 Ferdinands JM, Rao S, Dixon BE, et al. Waning 2-dose and 3-dose effectiveness of mRNA vaccines against COVID-19-associated emergency department and urgent care encounters and hospitalizations among adults during periods of Delta and Omicron variant predominance - VISION Network, 10 States, August 2021-January 2022. MMWR Morb Mortal Wkly Rep 2022 71(7): 255–63. Canetti M, Barda N, Gilboa M, et al. Six-Month Follow-up after a Fourth BNT162b2 Vaccine Dose. N Engl J Med 2022 387(22): 2092–4. Ramirez SI, Lopez PG, Faraji F, et al. Early antiviral CD4 + and CD8 + T cells are associated with upper airway clearance of SARS-CoV-2. JCI Insight 2024 20;9(24):e186078. Ramirez SI, Faraji F, Hills LB, et al. Immunological memory diversity in the human upper airway. Nature 2024 632(8025):630–636. Shang W, Kang L, Cao G, et al. Percentage of asymptomatic Infections among SARS-CoV-2 Omicron variant-positive Iindividuals: A systematic review and meta-analysis. Vaccines (Basel) 2022 10(7):1049. Yu W, Guo Y, Zhang S, Kong Y, Shen Z, Zhang J. Proportion of asymptomatic infection and nonsevere disease caused by SARS-CoV-2 Omicron variant: A systematic review and analysis. J Med Virol 2022 94(12): 5790–801. Garrett N, Tapley A, Andriesen J, et al. High asymptomatic carriage with the Omicron variant in South Africa. Clin Infect Dis 2022 75(1): e289-e92. Additional Declarations Yes there is potential Competing Interest. The corresponding author and those affiliated with GeneOne Life Science are full time employees of the company. YKP owns stock in GeneOne. Supplementary Files GLS5310INFigS1.pptx Figure S1: Antibody responses in NZWR vaccinated IN and/or ID with GLS-5310 GLS5310INFigS2a.pptx Figure S2a: Binding antibody responses in the CoV2-008 clinical trial by study arm. GLS5310INFigS2b.pptx Figure S2b: T cell immune responses in the CoV2-008 clinical trial by study arm. Cite Share Download PDF Status: Under Review Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6406233","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":442898863,"identity":"ba450720-201f-4de9-875b-e018d952e8c7","order_by":0,"name":"Joel Maslow","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAz0lEQVRIiWNgGAWjYBACxgYg8YCBQQ7Me0C0lgQGBmMwL4Foq4AqExuI1sI87fDjDwkVh9Pnu/cefJDwhyFxfgMhh81OM5NIOHM4d+OZc8kGiW0MiRsOENSSYMaQ2HY7d+OMHDMJoPMSNxByGOPs9M8fgFrSDee/Mf9BpMNyDCSAWhLkJXjMGBLYgOFA2GE5ZUC//DfcwJNjDNQrYUzQL4az0zd/+FCRJi/ffsbww4c/NrIEHWYIU2AAMVyCgHogkIczCBk+CkbBKBgFIxcAAAamRy5nBQgWAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0003-0305-5608","institution":"GeneOne Life Science, Inc.","correspondingAuthor":true,"prefix":"","firstName":"Joel","middleName":"","lastName":"Maslow","suffix":""},{"id":442898864,"identity":"a3732601-6df2-448c-93a7-f9d9072bc0b9","order_by":1,"name":"Javier Morales-Ramirez","email":"","orcid":"","institution":"Clinical Research of Puerto Rico","correspondingAuthor":false,"prefix":"","firstName":"Javier","middleName":"","lastName":"Morales-Ramirez","suffix":""},{"id":442898865,"identity":"88321410-652f-4941-81ba-c52e49959e29","order_by":2,"name":"Christine Roberts","email":"","orcid":"https://orcid.org/0000-0003-4359-7946","institution":"GeneOne Life Science, Inc.","correspondingAuthor":false,"prefix":"","firstName":"Christine","middleName":"","lastName":"Roberts","suffix":""},{"id":442898866,"identity":"209250ec-f39c-45a2-a889-568425bd232c","order_by":3,"name":"Susan Spruill","email":"","orcid":"https://orcid.org/0000-0002-0477-3305","institution":"Applied Statistics and Consulting","correspondingAuthor":false,"prefix":"","firstName":"Susan","middleName":"","lastName":"Spruill","suffix":""},{"id":442898867,"identity":"f0dab4f2-344b-48fa-bb72-96519060e071","order_by":4,"name":"Deborah Kane","email":"","orcid":"","institution":"GeneOne Life Science, Inc.","correspondingAuthor":false,"prefix":"","firstName":"Deborah","middleName":"","lastName":"Kane","suffix":""},{"id":442898868,"identity":"66965338-e779-4d6f-90b6-8c89413d019f","order_by":5,"name":"Melissa Gulley","email":"","orcid":"","institution":"GeneOne Life Science, Inc.","correspondingAuthor":false,"prefix":"","firstName":"Melissa","middleName":"","lastName":"Gulley","suffix":""},{"id":442898869,"identity":"f8e8d814-cd43-4155-bd52-ccc9e93ba9ac","order_by":6,"name":"Joel Muñoz-Coreano","email":"","orcid":"","institution":"Clinical Research of Puerto Rico","correspondingAuthor":false,"prefix":"","firstName":"Joel","middleName":"","lastName":"Muñoz-Coreano","suffix":""},{"id":442898870,"identity":"aa50661f-24f9-49c0-89dd-c05839605ca1","order_by":7,"name":"Sonia Velazquez-Navarro","email":"","orcid":"","institution":"Clinical Research of Puerto Rico","correspondingAuthor":false,"prefix":"","firstName":"Sonia","middleName":"","lastName":"Velazquez-Navarro","suffix":""},{"id":442898871,"identity":"3ae05af7-f5c6-477d-8ad0-0b847bb2b0cd","order_by":8,"name":"Jay Meyer","email":"","orcid":"","institution":"Velocity Clinical Research","correspondingAuthor":false,"prefix":"","firstName":"Jay","middleName":"","lastName":"Meyer","suffix":""},{"id":442898872,"identity":"4f86c9c9-cc85-4f70-91e7-8b2e6d958f4e","order_by":9,"name":"Sagar Kudchodkar","email":"","orcid":"","institution":"GeneOne Life Science, Inc.","correspondingAuthor":false,"prefix":"","firstName":"Sagar","middleName":"","lastName":"Kudchodkar","suffix":""},{"id":442898873,"identity":"7538897c-cb67-454e-8381-1be6c83739b4","order_by":10,"name":"Susan Mikota","email":"","orcid":"https://orcid.org/0000-0003-3470-0331","institution":"GeneOne Life Science, Inc.","correspondingAuthor":false,"prefix":"","firstName":"Susan","middleName":"","lastName":"Mikota","suffix":""},{"id":442898874,"identity":"e501eea7-4958-4b40-9ad3-4c7d0997ab9c","order_by":11,"name":"Stephen Kania","email":"","orcid":"","institution":"University of Tennessee, College of Veterinary Medicine","correspondingAuthor":false,"prefix":"","firstName":"Stephen","middleName":"","lastName":"Kania","suffix":""},{"id":442898875,"identity":"f3ab23a6-fe3a-43d9-8c2e-ed212e42aca3","order_by":12,"name":"Young Park","email":"","orcid":"","institution":"GeneOne Life Science, Inc.","correspondingAuthor":false,"prefix":"","firstName":"Young","middleName":"","lastName":"Park","suffix":""}],"badges":[],"createdAt":"2025-04-08 20:25:08","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6406233/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6406233/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":81966000,"identity":"f9519640-ae42-446f-a8fb-076914ddf279","added_by":"auto","created_at":"2025-05-05 11:34:19","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":41610,"visible":true,"origin":"","legend":"\u003cp\u003eStudy randomization\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-6406233/v1/8079f7687b4d67343675ddf6.png"},{"id":81965999,"identity":"3248afa0-1e53-40e0-a2cc-4781afa8b33c","added_by":"auto","created_at":"2025-05-05 11:34:19","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":33043,"visible":true,"origin":"","legend":"\u003cp\u003eKaplan Meier plot of time infection free post-vaccination\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCombined IN+ID vaccination vs ID vaccination alone\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-6406233/v1/5894819aacddbed43df37823.png"},{"id":81969145,"identity":"91b866e1-8765-468b-b48b-99d43be599ee","added_by":"auto","created_at":"2025-05-05 12:06:24","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1804223,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6406233/v1/1003b66f-0c49-463c-9f48-383a0cc5e6bf.pdf"},{"id":81966002,"identity":"337eaa47-cfd1-489d-8565-6e7c09955ff5","added_by":"auto","created_at":"2025-05-05 11:34:19","extension":"pptx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":394018,"visible":true,"origin":"","legend":"\u003cp\u003eFigure S1: Antibody responses in NZWR vaccinated IN and/or ID with GLS-5310\u003c/p\u003e","description":"","filename":"GLS5310INFigS1.pptx","url":"https://assets-eu.researchsquare.com/files/rs-6406233/v1/bdaf61ea085ea3d2e3df6d8c.pptx"},{"id":81968072,"identity":"58076a1d-79b4-44f5-9d4a-c660a4357aae","added_by":"auto","created_at":"2025-05-05 11:50:19","extension":"pptx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":1202195,"visible":true,"origin":"","legend":"\u003cp\u003eFigure S2a: Binding antibody responses in the CoV2-008 clinical trial by study arm.\u003c/p\u003e","description":"","filename":"GLS5310INFigS2a.pptx","url":"https://assets-eu.researchsquare.com/files/rs-6406233/v1/6cef4c89de5a2dcb4b9e51da.pptx"},{"id":81968879,"identity":"e06b2e58-c236-4b79-8633-4a3291467d93","added_by":"auto","created_at":"2025-05-05 11:58:19","extension":"pptx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":973195,"visible":true,"origin":"","legend":"\u003cp\u003eFigure S2b: T cell immune responses in the CoV2-008 clinical trial by study arm.\u003c/p\u003e","description":"","filename":"GLS5310INFigS2b.pptx","url":"https://assets-eu.researchsquare.com/files/rs-6406233/v1/6c2dbd373a6cdb1afb4dba62.pptx"}],"financialInterests":"\u003cb\u003eYes\u003c/b\u003e there is potential Competing Interest.\nThe corresponding author and those affiliated with GeneOne Life Science are full time employees of the company. YKP owns stock in GeneOne.","formattedTitle":"Prevention of incident SARS-CoV-2 infection through combined intranasal and intradermal administration of the GLS-5310 DNA vaccine during the Omicron outbreak","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eThe severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) is the third highly pathogenic human coronavirus to emerge. Unlike SARS-CoV and the Middle East respiratory syndrome coronavirus (MERS-CoV), SARS-CoV-2 appears to be more highly adapted to upper respiratory tract infection. SARS-CoV-2 has had rapid genetic evolution, especially within the receptor binding domain (RBD) of the spike (S) protein, that has resulted in increased nasal affinity and greater transmissibility \u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e,\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e. The Omicron lineage variants of SARS-CoV-2 were resistant to antibodies raised against earlier lineages, with each subsequent Omicron subvariant demonstrating increased escape against immune responses to earlier Omicron strains \u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eBooster vaccination against SARS-CoV-2 continues to be recommended since incident cases remain prevalent with new variants continuing to emerge. The protective efficacy of primary vaccination has been found to wane by 5 to 6 months \u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e,\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e, while antibodies induced by mRNA booster vaccination begin to decline by 2 months and substantially wane after 4 months \u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e,\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e. Heterologous combinations of primary and booster vaccines offer potential advantages including reduction of potential toxicities and reactogenicity of a particular vaccine type and the potential for greater breadth of T cell responses \u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eDevelopment of intranasal (IN) vaccines against SARS-CoV-2 vaccines commenced early in the pandemic with numerous candidate vaccines being developed, of which at least two advanced to Phase 3 studies \u003csup\u003e\u003cspan additionalcitationids=\"CR10 CR11\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. The reason for such interest is multifold asinitial nasal colonization and infection by SARS-CoV-2 is primarily via ciliated nasal mucosal cells which highly express both the angiotensin converting enzyme type 2 receptor (ACE2) and TMPRSS2, that serve as the cellular binding site for viral attachment and an accessory protein required for fusion and viral internalization, respectively \u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e,\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e. Notably, ACE2 and TMPRSS2 expression increases with age suggesting increased susceptibility to SARS-CoV-2 infection in the elderly \u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e. Also, systemically administered vaccines are considered as non-protective against viral transmission from mucosal spread \u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e,\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e a fact supported by intramuscular vaccination of macaques studies showing that showed incomplete or poor nasal clearance of virus despite the lack of detectable virus in the lungs \u003csup\u003e\u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e. DNA vaccines, administered intranasally, have also been considered as a means to induce mucosal immunity \u003csup\u003e\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u003c/sup\u003e. Different formulations that have been assessed in preclinical studies include naked DNA \u003csup\u003e\u003cspan additionalcitationids=\"CR21\" citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e or DNA encapsulated into polymeric or liposomal nanoparticles \u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e,\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eHere we report the results of the CoV2-008 clinical trial which assessed the safety and immunogenicity of the GLS-5310 DNA vaccine against SARS-CoV-2 given as a boost to those previously vaccinated with either the BNT162b2, mRNA-1273, or the Ad26.S.CoV vaccines. GLS-5310 was administered either ID alone using the GeneDerm suction device or IN as well as ID. To our knowledge, this study represents the first clinical trial of a DNA vaccine administered intranasally. GLS-5310 was well tolerated by either route of administration and induced both humoral and cellular responses that persisted for a year post-vaccination. Moreover, study participants vaccinated both IN and ID with GLS-5310 reported a significantly lower rate of incident cases of SARS-CoV-2 infection relative to those vaccinated ID alone during a period of high transmissibility of SARS-CoV-2 Omicron variants.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eGLS-5310 vaccine\u003c/h2\u003e \u003cp\u003eThe GLS-5310 vaccine, formulated from the pGO-1002 plasmid, has been described in detail elsewhere \u003csup\u003e\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u003c/sup\u003e. Briefly, the pGO-1002 plasmid encodes for the SARS-CoV-2 spike (S) and open reading frame 3a (ORF3a), with the S and ORF3a transgenes designed as consensus sequences of SARS-CoV-2 strains uploaded to GenBank through February 2020 \u003csup\u003e25\u003c/sup\u003e. GLS-5310 at a concentration of 6 mg/ml was used for both ID and IN immunization.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eToxicologic assessment of GLS-5310 administered IN and ID to New Zealand White Rabbits\u003c/h3\u003e\n\u003cp\u003eA 4-week repeated dose toxicology study of combined IN and ID GLS-5310 vaccine administration was performed at Biotoxtech Co., Ltd. (Cheongju-Si, Republic of Korea) under good laboratory practices (GLP). The study was reviewed and approved by the Institutional Animal Care and Use Committee (IACUC) of Biotoxtech (approval No. 200588). Animal care was in accordance with the Animal Protection Act of Korea and the Guide for the Care and Use of Laboratory Animals.\u003c/p\u003e \u003cp\u003eSeventeen-week-old New Zealand white rabbits (NZWR) were vaccinated ID and IN with either GLS-0001 (SSC formulation buffer as placebo control) or 1.2 mg of GLS-5310 SARS-CoV-2 vaccine. A total of 16 male and 16 female rabbits were included with 8 of each sex administered placebo or vaccine. For ID vaccinations, animals were inoculated into a shaved and depilated region of back, after which suction was applied over the injection site using GeneDerm suction device (65 kPa, 30 sec). Animals were vaccinated twice with a two-week interval between vaccinations. Each ID inoculation consisted of two injections ID of 0.1 ml of either GLS-0001 or GLS-5310, the latter calculated to achieve a total ID dose of 1.2 mg. For IN vaccinations, animals were administered 0.2 ml of either GLS-0001 or GLS-5310 into one nostril using the MAD300 atomizer (Teleflex, Wayne, PA, USA) attached to a 3 ml syringe. Thus, GLS-5310 vaccinated animals received a total dose of 2.4 mg.\u003c/p\u003e \u003cp\u003eAnimals were monitored for clinical signs and symptoms and ophthalmologic examinations were performed at baseline and at 4-week intervals. Hematology and clinical chemistries to assess renal and hepatic function were obtained at baseline and just prior to necropsy. Five animals per sex per group were followed through to the final vaccination and then euthanized. Three animals per sex per group were followed for a 4-week recovery period. Following the 4-week recovery, animals were euthanized, and necropsy performed for gross and histologic evaluation of organs.\u003c/p\u003e\n\u003ch3\u003eImmunologic assessment of rabbits vaccinated ID and/or IN with GLS-5310\u003c/h3\u003e\n\u003cp\u003eFemale, New Zealand white rabbits were vaccinated twice at a 21-day interval. For each vaccination, animals were inoculated once with 200 \u0026micro;g of GLS-5310 in a volume of 0.1 mL or with 0.1 mL of SSC by ID injection into a shaved and then depilated region over the scapula using the Mantoux technique. Injections were then followed by application of suction using the GeneDerm device (65 kPa, 30 sec). For IN administration, 200 \u0026micro;g of vaccine in 0.1 mL of vaccine or 0.1 mL of SSC placebo were administered using the MAD300 atomizer (Teleflex) into one nostril. Serum was collected from each rabbit on days 1, 14, 21, 35, 56 and 77, and stored at -80\u0026deg;C until analysis. The study, performed under protocol 2788\u0026thinsp;\u0026minus;\u0026thinsp;0920, was approved by the University of Tennessee Institutional Animal Care and Use Committee\u003c/p\u003e \u003cp\u003eFor ELISA determinations, SARS-CoV-2 spike recombinant proteins were expressed with the Fc region of human IgG1 at the C-terminus (40591-V02H, Sino Biological, Chesterbrook PA) and used as the antigen for IgA and IgM assays while spike protein with a His-flag tag (RP-87671, Invitrogen, Waltham, MA) used as the antigen for IgG assays. Detecting antibodies were affinity purified, anti-rabbit Ig, class specific, HRP conjugates, obtained commercially (Bethyl Laboratories, Montgomery TX).\u003c/p\u003e \u003cp\u003eTo prepare each microtiter plate for ELISA, antigen diluted in phosphate buffered saline was added to each well and allowed to bind overnight at 4\u0026deg;C. Plates were washed three times with phosphate buffered saline (PBS) containing 0.05% tween (PBST). Serum was diluted in PBST, added to duplicate wells, and incubated at 37\u0026deg;C. Plates were washed and horse radish peroxidase (HRP) conjugated anti-class specific antibody diluted in PBST was added. Samples were incubated at 37\u0026deg;C and then washed. TMB substrate (N301, Pierce Biotechnology, Waltham, MA) was added and the reactions were stopped with 0.18 M sulfuric acid. Optical densities were determined at 450 nm on a plate reader. Values from blank wells that did not receive rabbit serum were subtracted from the optical density readings of all samples on the same plate.\u003c/p\u003e\n\u003ch3\u003eStudy participants and procedures\u003c/h3\u003e\n\u003cp\u003eThe CoV2-008 clinical trial was a randomized, open-label study to assess the safety and immunogenicity of the GLS-5310 DNA vaccine administered to those previously vaccinated against SARS-CoV-2 as a single booster of either ID alone or ID plus IN. Adult subjects, age 18 to 65 years old, who had completed a primary vaccination series with either the BNT162b2, mRNA-1273, or Ad26.CoV.S vaccine were enrolled. Receipt of a pre-study an mRNA booster vaccination was non-exclusionary if the most recent vaccination (booster or primary) was at least 5 months prior to enrollment. Those with symptoms of or known recent infection with SARS-CoV-2 were excluded, although distant infection was not an exclusion. Women of childbearing potential had pregnancy testing performed prior to vaccination. Pregnancy, or planned pregnancy during the study, and active breast feeding were exclusionary. The full list of inclusion and exclusion criteria are included in the protocol (supplementary material) and at ClinicalTrials.Gov (NCT05182567). The study was conducted at clinical sites in San Juan, Puerto Rico; Rockville, Maryland; and Lincoln, Nebraska. The study was reviewed and approved by the Institutional Review Board (IRB) at each study site.\u003c/p\u003e \u003cp\u003eThe study enrolled participants into one of four study arms to evaluate alternate delivery conditions for GLS-5310 boosters, each arm with three sub-strata based on the primary vaccinations received. Participants randomized to study arm 1 were administered GLS-5310 ID using a GeneDerm device programmed to deliver a suction pressure of 65 kPa for 30 sec (65 kPa/30 sec). Participants randomized to study arm 2 were vaccinated ID using the 65 kPa/30 sec GeneDerm device and were also vaccinated IN using the MAD300 atomizer. Participants randomized to study arm 3 were vaccinated ID using a 65 kPa/15 sec suction device, while participants randomized to study arm 4 were vaccinated ID using an 80 kPa/30 sec GeneDerm device. All participants received a dose of GLS-5310 vaccine of 1.2 mg ID; whereas for those in study arm 2, an additional 1.2 mg was administered IN. ID vaccinations were divided into two 0.6 mg doses and administered into the volar aspect of the forearm using the Mantoux technique with suction applied over the injection site immediately after each administration. IN vaccinations were performed using the MAD300 atomizer with the entire 1.2 mg administered to one nostril.\u003c/p\u003e \u003cp\u003eStudy visits occurred at baseline, 4 weeks post-booster vaccination, and then at 12, 24, and 48 weeks. Reviews of adverse reactions were conducted at each study visit, including any confirmed diagnosis of new COVID-19 infections. Laboratory assessments to include complete blood counts and serum chemistries were conducted at study visits prior to and following GLS-5310 vaccination. Serum and whole blood for peripheral blood mononuclear cells (PBMCs) were collected at the study visits to perform immunological assessments.\u003c/p\u003e\n\u003ch3\u003eImmunologic assessments for CoV2-008 study vaccinees\u003c/h3\u003e\n\u003cp\u003eQuantitative assessment of serum IgG antibodies against the SARS-CoV-2 spike protein were determined by enzyme linked immunosorbent assay (ELISA). Recombinant SARS-CoV-2 full length Spike protein (ACROBiosystems) was bound to solid phase 96-well microtiter plates overnight at 4\u0026deg;C. Plates were washed and blocked with milk diluent (SeraCare) then incubated with dilutions of serum from participants, in duplicate. IgG detection was performed with horseradish peroxidase enzyme-conjugated anti-human IgG (SeraCare) secondary reagent and KPL ABTS\u0026reg; Peroxidase Substrate (SeraCare). Optical density at 405 nm was measured on a standard microplate reader. Titers were calculated against the Frederick National Laboratory Serum COVID-NS01097, calibrated to the WHO international serology standard (20/136) and reported as binding antibody units per mL (BAU/mL).\u003c/p\u003e \u003cp\u003eQuantitative assessment of serum and salivary IgA antibodies against the SARS-CoV-2 spike protein were determined by ELISA. Recombinant SARS-CoV-2 Spike protein (ACROBiosystems) was bound to solid phase 96-well microtiter plates overnight at 4⁰C. Plates were washed and blocked with milk diluent (SeraCare) then incubated with serum from participants, in duplicate. IgA detection was performed with horseradish peroxidase enzyme-conjugated anti-human IgA (SeraCare) secondary reagent and KPL ABTS\u0026reg; Peroxidase Substrate (SeraCare). Optical density at 405 nm was measured on a standard microplate reader. Titers were calculated against the Frederick National Laboratory Serum COVID-NS01097, calibrated to the WHO international serology standard (20/136) and reported as arbitrary units per mL (AU/mL) as no standardized units have been assigned specifically for the detection of IgA.\u003c/p\u003e \u003cp\u003eDetermination of T cell responses against the SARS-CoV-2 spike and ORF3a proteins was by interferon gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assay. Briefly, frozen PBMCs were thawed and rested overnight. Human IFN-γ ELISpotPRO (Mabtech) plates pre-coated with IFN-γ specific capture antibody were washed and blocked with media containing 10% FBS. Cells were stimulated for 18\u0026ndash;24 hours with each of five pools of 15-mer peptides, overlapping by 11 amino acids, spanning the entire SARS-CoV Spike and ORF3A proteins (custom synthesis by GenScript). Secreted IFN-γ was detected with an alkaline phosphatase conjugated antibody and signal was developed using a BCIP/NBT-plus substrate. Spots were counted using a BioTek Cytation 7 plate reader and Gen5 3.11 software. Spot counts for each peptide pool were calculated as background-subtracted SFU/million PBMCs and results for each of the five peptide pools added to report a total SFU/million PBMCs.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eStatistics\u003c/h2\u003e \u003cp\u003eStatistical analysis of immune response and treatment failure (COVID infection) was performed on a modified intention-to-treat population which consisted of all participants who received booster treatment, regardless if they completed all follow up visits. Participants with both baseline and post-baseline samples for immune response were included in the summaries of immunogenicity.\u003c/p\u003e \u003cp\u003eParticipants were grouped into 2 categories of boosters, with or without IN component, ignoring primary vaccine. The proportion of infected participants in each group were compared using chi-square test. Ninety-five percent confidence interval of differences in proportions were computed using exact methods. Time to COVID infection was determined as the number of days from booster to the date of confirmed COVID infection. Those participants who completed all study visits without infection or who were lost to follow up were censored at the last known contact date. Survival distribution functions were calculated using procedure LIFETEST in SAS (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ewww.sas.com\u003c/span\u003e\u003cspan address=\"http://www.sas.com\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e) where the group differences in time to COVID infection are estimated using the product limit method (Kaplan-Meier method). Statistical significance of group differences in time to infection were evaluated using log-rank test.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eToxicologic assessment of GLS-5310 in NZWR\u003c/h2\u003e \u003cp\u003eThe toxicology of GLS-5310 administered both IN and ID with the GeneDerm device was assessed in NZWR. GLS-5310 was well tolerated with no test article-related changes in physical signs, laboratory results, organ weights, organ appearance, or histopathology. Specifically, there was no of trauma on gross examination or histologic evidence of pathology at the ID site of vaccine administration, consistent with a previous toxicology study of ID administration of GLS-5310 \u003csup\u003e26\u003c/sup\u003e. Examination of the nares of animals administered GLS-5310 IN showed no evidence of gross or microscopic signs of inflammation, with findings non-different from control animals.\u003c/p\u003e \u003cp\u003e \u003cb\u003eConcurrent IN and ID administration of GLS-5310 DNA vaccine in New Zealand White Rabbits induced high, IgG and IgA serum immune responses\u003c/b\u003e \u003c/p\u003e \u003cp\u003eAnimals tolerated vaccination well without evident systemic or administration site changes. Serum immune responses are shown in Figure \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e. ID vaccinated animals had high anti-spike IgG responses, which were highest for animals vaccinated both ID and IN, whereas animals vaccinated IN had minimal to no IgG antibodies detected (Figure \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003ea). In contrast, marked anti-spike IgA responses were observed in the two groups of animals vaccinated IN (Figure \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003eb). Notably, whereas animals vaccinated IN demonstrated rapid decay of serum IgA responses after day 21, those vaccinated both IN and ID had a higher magnitude, persistent response that was detectable through to study day 77.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eCoV2-008 clinical trial enrollment and demographics\u003c/h2\u003e \u003cp\u003eA total of 70 persons were enrolled into the CoV2-008 clinical trial with the first enrollment on 23 May 2022 and the last study visit on 07 July 2023. There were 34 persons enrolled at the San Juan, PR site ; 25 at Lincoln, NE; and 11 enrolled at Rockville, MD. Demographics of those participating in the study are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. The average age of study participants was 43.4 years and 43 (61.4%) were female. With regard to race and ethnicity 55 (78.6%) were Caucasian, 13 (18.6%) were black or African American, 1 (1.4%) was Asian, and 36 (51.4%) were Hispanic or Latino. The average participant weight was 90.0 kg with a mean calculated body mass index (BMI) of 31.7 kg/m\u003csup\u003e2\u003c/sup\u003e, median of 31.2, and range from 16.6 to 54.1.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDemographics of participants in the CoV2-008 clinical trial\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eStudy\u003c/p\u003e \u003cp\u003eArm 1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eStudy\u003c/p\u003e \u003cp\u003eArm 2\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eStudy\u003c/p\u003e \u003cp\u003eArm 3\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eStudy\u003c/p\u003e \u003cp\u003eArm 4\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGeneDerm settings\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e65 kPa, 30 sec\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e65 kPa, 30 sec\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e65 kPa, 15 sec\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e80 kPa, 30 sec\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIntranasal vaccination\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNumber in study arm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge (years)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e45.7 (12.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e37.6 (9.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e43.2 (11.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e47.3 (9.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e47.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e46.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e46.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26, 63\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23, 54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e22, 60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e29, 65\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFemale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12 (60%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (52.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12 (63.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10 (71.4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (40%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (47.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7 (36.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4 (29.6%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRace\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWhite\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16 (80%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14 (82.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15 (78.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e10 (71.4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBlack, African American\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (15.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (17.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (21.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (21.4%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAmerican Indian, Alaskan Native\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (7.1%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAsian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (5.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNative Hawaiian, Pacific Islander\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOther\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEthnicity\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHispanic or Latino\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12 (60.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8 (47.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8 (42.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e8 (57.1%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNot Hispanic or Latino\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (40.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (52.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e11 (57.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6 (42.9%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHeight (cm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e168.8 (10.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e169.7 (10.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e168.0 (8.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e165.1 (7.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e166.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e170.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e168.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e165.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e156, 190\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e146, 186\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e153, 189\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e152, 178\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWeight (kg)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e79.4 (22.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e99.1 (28.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e93.7 (25.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e89.3 (21.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e76.40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e91.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e86.70\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e86.45\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e44.0, 125.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e47.4, 161.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e66.0, 154.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e59.6, 136.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean (SD)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e27.5 (5.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e34.2 (8.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e33.1 (8.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e32.7 (7.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedian\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e28.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e33.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e31.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e31.4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMin, Max\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16.6, 36,6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20.8, 52.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e23.5, 54.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e22.4, 50.3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eStudy randomization is shown in Fig.\u0026nbsp;1. With regard to study-arm sub-strata, 23 participants received the BNT162b2 vaccine as their primary immunization series, 23 received the mRNA-1273 vaccine, and 24 received the Ad26.CoV.S vaccine. There were 8 participants who terminated the study prior to the final study visit, one each in study arms 1 and 2, four in study arm 3, and two in study arm 4. Reasons for early termination included lost to follow-up (n\u0026thinsp;=\u0026thinsp;6), relocation out of region (n\u0026thinsp;=\u0026thinsp;1), and voluntary withdrawal (n\u0026thinsp;=\u0026thinsp;1).\u003c/p\u003e \u003cp\u003eA total of 45 (64.3%) study participants received an mRNA booster, at least 5 months prior to GLS-5310 vaccination. For those who did not receive a booster vaccination, the mean (median, range, SD) of time from their first primary vaccination to when they received study vaccine was 399.4 days (405, 273\u0026ndash;532, 67.8) and for those who received a booster vaccine the time from most recent vaccination to receipt of study vaccine was 211.9 days (211.5, 166\u0026ndash;258, 24.6). A higher percentage of those who were vaccinated ID only had received a booster vaccination (37 of 53, 69.8%) versus those vaccinated IN plus ID (8 of 17, 47.1%; p\u0026thinsp;=\u0026thinsp;0.5). In both the ID only and ID plus IN groups, days between pre-study vaccination to receipt of GLS-5310 were similar regardless of whether they had received an mRNA booster (mean of 211.5 days for those vaccinated ID only versus 217.5 days for those vaccinated ID plus IN) or had not received an mRNA booster (391.3 versus 405.0 days).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eVaccine safety\u003c/h2\u003e \u003cp\u003eGLS-5310 vaccination was well tolerated, regardless of the route of administration or the GeneDerm device used. A total of 59 (84.3%) participants reported at least one treatment emergent adverse event (TEAE, Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). All TEAE were grade 1 or 2 and resolved spontaneously except for one participant in study arm 2 who was found to have a supraventricular dysrhythmia by initial ECG at the week 12 study visit and was diagnosed with a non-ischemic cardiomyopathy that was considered as non-study related by the investigator. Injection site reactions and general disorders were the most common reported AEs for 49 (70.0%) of participants that included injection site erythema for 26 (37.1%), asthenia for 16 (21.4%), and injection site pruritis 16 (21.4%), and injection site bruising for 12 (17.1%).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eTreatment emergent adverse effects by System Organ Class by study arm\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eStudy\u003c/p\u003e \u003cp\u003eArm 1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eStudy\u003c/p\u003e \u003cp\u003eArm 2\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eStudy\u003c/p\u003e \u003cp\u003eArm 3\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eStudy\u003c/p\u003e \u003cp\u003eArm 4\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGeneDerm pressure settings\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e65 kPa\u003c/p\u003e \u003cp\u003e30 sec\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e65 kPa\u003c/p\u003e \u003cp\u003e30 sec\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e65 kPa\u003c/p\u003e \u003cp\u003e15 sec\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e80 kPa\u003c/p\u003e \u003cp\u003e30 sec\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIntranasal vaccination\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eYes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eNo\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNumber in study arm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSystem organ class\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParticipants with at least one TEAE\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e17 (86.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16 (88.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e16 (78.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12 (86.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGeneral disorders, administration site conditions\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14 (70.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12 (70.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12 (63.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11 (78.6%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNervous system disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (40.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (41.2%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6 (31.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e8 (67.1%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInfections and infestations *\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (35.%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (11.8%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e9 (47.4%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6 (35.7%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMusculoskeletal and connective tissue disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (15.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (35.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4 (21.1%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6 (42.9%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRespiratory, thoracic and mediastinal disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (10.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (36.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (7.1%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGastrointestinal disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (6.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (17.6%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (7.1%)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePsychiatric disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (10.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCardiac disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (6.9%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eImmune system disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (6.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInjury, poisoning, procedural complications\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (6.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePregnancy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReproductive system and breast disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1 (6.3%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSkin and subcutaneous tissue disorders\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (6.0%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003e* Infections and infestations are inclusive of COVID-19 infections\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eRespiratory and thoracic complaints were reported for 10 (14.3%) of participants and was more common for those who also received GLS-5310 nasally: 6 (36.3%) of 17 vaccinated IN plus ID versus 4 (7.5%) vaccinated ID only. Specific complaints of those vaccinated with GLS-5310 IN plus ID relative to ID only included rhinorrhea in 3 (17.6%) versus 2 (3.8%), nasal congestion in 2 (11.8%) versus 1 (1.9%), cough 2 (11.8%) versus none, and wheezing in 2 (11.8%) versus none. Epistaxis was reported for 1 (6.9%) person vaccinated IN plus ID versus none vaccinated ID only. Other reported AEs were not different bewteen study arms except for a lower rate of infections and infestations for those vaccinated both ID and IN that is addressed below.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eImmune responses following booster vaccination with GLS-5310\u003c/h2\u003e \u003cp\u003eSince primary vaccination type has been shown to be a determinate of antibody responses post boost vaccination \u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e, we examined immune responses for each primary vaccine type regardless of study arm and for each sub-group within the four study arms (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e3\u003c/span\u003ea). Consistent with other studies \u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e, baseline titers were higher for those initially vaccinated with an mRNA vaccine versus an adenoviral vaccine (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e3\u003c/span\u003ea). The largest increase of anti-spike IgG titers post-boost were observed for those originally vaccinated with the Ad26.CoV.S vaccine, of approximately 3- to 4-fold (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e3\u003c/span\u003eb). For those who were initially vaccinated with an mRNA vaccine, post-boost increases were in general in the 1.5- to 1.7-fold range, although those in study arm 1 who were vaccinated initially with mRNA-1273 had a 2.85 increase in titers 2-weeks post-vaccination. Of interest, for many sub-groups, peak IgG responses were observed at week 12 post-vaccination (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e3\u003c/span\u003eb), consistent with a prior Phase 1 study of GLS-5310 administered with GeneDerm to vaccine-na\u0026iuml;ve recipients \u003csup\u003e\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e, although the small sample size in this study precludes definitive conclusions.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ea: Spike ELISA relative to study arm and primary vaccine type\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"14\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c12\" colnum=\"12\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c13\" colnum=\"13\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c14\" colnum=\"14\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c5\" namest=\"c3\"\u003e \u003cp\u003eArm 1\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u003c/p\u003e \u003cp\u003eGeneDerm 65kPa/30s\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c8\" namest=\"c6\"\u003e \u003cp\u003eArm 2\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u0026thinsp;+\u0026thinsp;IN\u003c/p\u003e \u003cp\u003eGeneDerm 65kPa/30s\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c11\" namest=\"c9\"\u003e \u003cp\u003eArm 3\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u003c/p\u003e \u003cp\u003eGeneDerm 65kPa/15s\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c14\" namest=\"c12\"\u003e \u003cp\u003eArm 4\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u003c/p\u003e \u003cp\u003eGeneDerm 80kPa/30s\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003ePrimary vaccine\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c14\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBaseline\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003egmt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9422.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e17168.97\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e16516.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e15055.09\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e16259.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e15585.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e6538.61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e17765.37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e13623.86\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e4302.58\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e7884.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e6811.38\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI H\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e30448.11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e50663.10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e37530.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e46235.83\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e51836.04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e36990.10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e27751.72\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e61379.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e35861.74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e38967.78\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e17544.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e56033.89\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI L\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2915.60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5818.31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7268.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4902.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e5100.11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e6566.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e1540.57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e5141.93\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e5175.70\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e475.06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e3542.87\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e827.98\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003egmt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12256.61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e48884.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e16321.10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e13102.89\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e11418.40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e16591.20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e8890.20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e19153.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e13907.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e4094.14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e13840.81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e4898.46\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI H\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e30772.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e96189.07\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e68109.61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e33588.92\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e38422.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e57766.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e41866.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e94506.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e32734.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e25827.22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e66600.39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e36157.43\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI L\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4881.83\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e24844.06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3911.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5111.38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3393.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e4765.20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e1887.82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e3881.74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e5908.35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e649.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e2876.38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e663.62\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003egmt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7033.68\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e25819.65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e15950.51\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e14901.77\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e10926.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e15882.19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e8235.65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e17392.56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e9968.65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e3612.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e9530.61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e10098.41\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI H\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16885.80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e64127.66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e38011.37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e52412.73\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e41788.90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e49366.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e38558.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e64605.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e20295.91\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e24197.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e33878.65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e90198.85\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI L\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2929.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e10395.73\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6693.23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4236.81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e2856.90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e5109.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e1759.04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e4682.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e4896.26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e539.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e2681.11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e1130.59\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003egmt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15569.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15627.38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e22360.87\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e27716.57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e14622.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e14483.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e28915.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e26692.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e20791.58\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e11444.24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e11348.89\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e7603.47\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI H\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e59570.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e38356.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e39769.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2124084.21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e69851.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e31012.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e92230.86\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e78199.56\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e77868.65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e36791.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e46832.90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e39177.83\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI L\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4069.11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6366.90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12572.63\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e361.67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e3060.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e6764.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e9065.07\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e9111.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e5551.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e3559.82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e2750.14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e1475.65\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003egmt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18577.77\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e14790.67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e17718.52\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e14338.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e12511.58\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e18751.48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e30451.63\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e27537.90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e17091.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e7142.19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e9561.92\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e7943.62\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI H\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e77123.82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e27426.36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e42844.69\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e71455.29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e35663.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e63357.26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e137470.49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e56545.31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e27315.15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e101385.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e34870.81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e1409352.43\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI L\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4475.06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7976.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7327.54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2877.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4389.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e5549.77\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e6745.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e13411.12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e10693.80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e503.14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e2621.97\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e44.77\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003egmt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e31931.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e25950.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e12715.54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e15185.66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e14393.22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e16162.88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e11643.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e24114.39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e17669.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e13042.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e12219.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e9489.55\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI H\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e80759.90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e47631.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e50623.23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e48405.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e36802.54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e63722.49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e34323.12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e108379.02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e55365.31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e37554.37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e79651.57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e89397.58\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI L\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12625.44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e14138.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3193.89\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4764.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e5629.09\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e4099.63\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e3949.94\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e5365.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e5638.81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e4529.49\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e1874.59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e1007.32\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"14\"\u003eData are reported as geometric mean titers (GMT) in international units (IU)/ml against the SARS-CoV-2 ancestral spike antigen.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eb: Fold change in spike ELISA relative to baseline relative to study arm and primary vaccine type\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"13\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c12\" colnum=\"12\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c13\" colnum=\"13\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eArm 1\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u003c/p\u003e \u003cp\u003eGeneDerm 65kPa/30s\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c7\" namest=\"c5\"\u003e \u003cp\u003eArm 2\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u0026thinsp;+\u0026thinsp;IN\u003c/p\u003e \u003cp\u003eGeneDerm 65kPa/30s\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c10\" namest=\"c8\"\u003e \u003cp\u003eArm 3\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u003c/p\u003e \u003cp\u003eGeneDerm 65kPa/15s\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c13\" namest=\"c11\"\u003e \u003cp\u003eArm 4\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u003c/p\u003e \u003cp\u003eGeneDerm 80kPa/30s\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk02\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.301\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.847\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.988\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.870\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.702\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1.065\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1.360\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e1.078\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e1.021\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e0.952\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e1.756\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e0.719\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.747\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.504\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.966\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.990\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.672\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1.019\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1.260\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e0.979\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e0.732\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e0.840\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e1.209\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e1.483\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.652\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.910\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.354\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1.841\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.899\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.929\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e4.422\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e1.503\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e1.526\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e2.660\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e1.439\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e1.116\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.972\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0.861\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.073\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.952\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.769\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1.203\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e4.657\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e1.550\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e1.254\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e1.660\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e1.213\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e1.166\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.389\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.511\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.770\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1.009\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.885\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e1.037\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1.781\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e1.357\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e1.297\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e3.031\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e1.550\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e1.393\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAnti-spike IgG antibody responses by study arm are shown in Figure \u003cspan refid=\"MOESM2\" class=\"InternalRef\"\u003eS2\u003c/span\u003ea. Antibody responses are seen to be non-different regardless of which GeneDerm setting (65 kPa/15 seconds, 65 kPa/30 seconds, or 80 kPa/30 seconds) was used for ID delivery of GLS-5310.\u003c/p\u003e \u003cp\u003eWith regards to post-boost T cell responses, increases relative to baseline were evident relative to primary vaccine type (Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e4\u003c/span\u003ea). In general, the largest increases in T cell response were observed for those previously vaccinated with an mRNA vaccine and ranged as high as 14.4-fold above baseline (Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e4\u003c/span\u003eb). While small increases in T cell responses were observed starting at 4 weeks post-boost vaccination, T cell responses typically peaked at either 12 or 24 weeks post-boost and persisted at elevated levels through 48 weeks (Table\u0026nbsp;\u003cspan refid=\"Tab6\" class=\"InternalRef\"\u003e4\u003c/span\u003ea), which was similarly consistent with our Phase 1 study in vaccine-na\u0026iuml;ve recipients \u003csup\u003e\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ea. T Cell Immune response by study arm and relative to primary COVID-19 vaccine type\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"14\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c12\" colnum=\"12\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c13\" colnum=\"13\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c14\" colnum=\"14\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c5\" namest=\"c3\"\u003e \u003cp\u003eArm 1\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u003c/p\u003e \u003cp\u003eGeneDerm 65kPa/30s\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c8\" namest=\"c6\"\u003e \u003cp\u003eArm 2\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u0026thinsp;+\u0026thinsp;IN\u003c/p\u003e \u003cp\u003eGeneDerm 65kPa/30s\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c11\" namest=\"c9\"\u003e \u003cp\u003eArm 3\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u003c/p\u003e \u003cp\u003eGeneDerm 65kPa/15s\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c14\" namest=\"c12\"\u003e \u003cp\u003eArm 4\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u003c/p\u003e \u003cp\u003eGeneDerm 80kPa/30s\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003ePrimary vaccine\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c14\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBaseline\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003egmt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e365\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e301.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e251.43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e146.67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e121.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e79.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e394.76\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e101.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e393.09\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e478.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e110.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e380.00\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI H\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e877.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e671.77\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e548.65\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e333.75\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e230.47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e136.98\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e893.93\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e185.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e967.57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e1258.89\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e260.91\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e984.72\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI L\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-147.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-67.88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-45.79\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-40.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e13.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e21.35\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e-104.41\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e18.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e-181.38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e-302.89\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e-40.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e-224.71\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003egmt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e791.43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e108.89\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e145.83\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e224.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e151.39\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e156.95\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e336.43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e289.45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e593.61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e603.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e111.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e150.83\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI H\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1966.47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e187.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e349.63\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e628.97\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e420.05\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e402.59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e751.57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e656.21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e1739.03\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e1639.97\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e281.01\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e441.94\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI L\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-383.61\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e30.36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-57.96\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-180.97\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-117.27\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e-88.70\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e-78.71\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e-77.32\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e-551.81\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e-433.97\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e-58.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e-140.27\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003egmt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2411.43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e181.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e76.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e131.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e180.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e131.67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e282.92\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e253.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e787.92\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e562.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e92.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e156.88\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI H\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5692.48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e411.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e154.48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e363.67\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e501.68\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e364.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e469.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e511.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e2429.64\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e1481.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e261.20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e491.32\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI L\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-869.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-49.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-1.98\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-101.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-140.85\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e-101.28\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e96.83\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e-4.86\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e-853.80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e-356.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e-76.20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e-177.57\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003egmt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2000.36\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e181.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e152.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e417.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e147.08\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e104.17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e277.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e320.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e1306.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e814.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e160.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e1191.67\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI H\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5098.45\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e411.84\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e265.10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1149.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e327.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e152.51\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e572.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e508.82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e3200.66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e2110.88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e422.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e4038.77\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI L\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-1097.74\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-49.34\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e39.90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-315.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e-33.46\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e55.83\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e-18.53\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e131.18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e-588.16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e-481.88\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e-101.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e-1655.44\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003egmt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1597.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e932.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e100.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e450.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e111.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e750.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e347.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e602.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e692.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e1765.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e74.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e1135.83\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI H\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3964.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2670.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e214.13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1257.47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e184.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e2428.26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e672.57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e1275.06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e1628.59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e5258.38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e135.37\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e2352.88\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e95CI L\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e-769.33\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e-805.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e-13.30\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-357.47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e38.00\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e-927.42\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e21.43\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e-70.06\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e-244.59\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e-1728.38\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e12.63\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e-81.21\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"14\"\u003eData are reported as total SFU/10\u003csup\u003e6\u003c/sup\u003e PBMCs as determined by ELISpot\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab6\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eb. T cell immune responses \u0026ndash; fold rise from baseline\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"13\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c12\" colnum=\"12\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c13\" colnum=\"13\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eArm 1\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u003c/p\u003e \u003cp\u003eGeneDerm 65kPa/30s\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c7\" namest=\"c5\"\u003e \u003cp\u003eArm 2\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u0026thinsp;+\u0026thinsp;IN\u003c/p\u003e \u003cp\u003eGeneDerm 65kPa/30s\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c10\" namest=\"c8\"\u003e \u003cp\u003eArm 3\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u003c/p\u003e \u003cp\u003eGeneDerm 65kPa/15s\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c13\" namest=\"c11\"\u003e \u003cp\u003eArm 4\u003c/p\u003e \u003cp\u003eGLS-5310 ID\u003c/p\u003e \u003cp\u003eGeneDerm 80kPa/30s\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003eAD26CoVS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003emRNA1273\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003eBNT162b2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk04\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1.552\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.063\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.643\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1.279\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.809\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e5.776\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.762\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e5.375\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e4.535\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e1.195\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e0.988\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e0.551\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.065\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.748\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.270\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1.070\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1.919\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e4.661\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1.163\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e4.741\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e1.545\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e0.588\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e0.595\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e0.594\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk24\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.430\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.331\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.444\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4.385\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1.040\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e10.468\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e0.721\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e4.014\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e10.078\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e2.440\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e1.311\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e2.631\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWk48\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.647\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.367\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.577\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2.345\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1.034\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e14.443\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e1.181\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e \u003cp\u003e5.446\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e \u003cp\u003e1.644\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e \u003cp\u003e2.024\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e \u003cp\u003e0.460\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e \u003cp\u003e3.250\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eT cell responses for each study arm are shown in Figure \u003cspan refid=\"MOESM2\" class=\"InternalRef\"\u003eS2\u003c/span\u003eb with a broad-based increase from baseline. As was observed for the binding antibody response, there was no apparent difference related to route of vaccine administration or GeneDerm setting.\u003c/p\u003e \u003cp\u003eSerum and salivary IgA responses were compared for Arm 1 versus Arm 2 participants, who were vaccinated ID using the 65 kPa/30 and differed as to vaccination ID only versus ID plus IN, respectively. Saliva was collected at baseline, and at study visits at week 2, 4, and 12. Anti-spike IgA levels were not significantly different between baseline and later time points for either the ID or ID plus IN group (data not shown).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003ePotential protective effect against SARS-CoV-2 infection from ID plus IN vaccination with GLS-5310\u003c/h2\u003e \u003cp\u003eA total of 17 persons in the CoV2-008 clinical trial reported incident confirmed SARS-CoV-2 infection during the study. The first reported infection occurred on study day 16 and the last on study day 250. All of the infections were self-limited, not requiring hospitalization. Only 1 (5.9%) of 17 participants who were vaccinated IN and ID reported SARS-CoV-2 infection (67.2 per 1000 person years, 95% CI 52.8 to 85.1) versus 16 (30.2%) of the 53 participants vaccinated ID only (450.9 per 1000 person years, 95% CI 410.3 to 493.6). This represented a 24.3% difference in proportion of infections which was statistically significant (p\u0026thinsp;=\u0026thinsp;0.042. 95% CI: 14.7%, 36.0%). Kaplan-Meier estimate of time to SARS-CoV-2 infection is shown in Fig.\u0026nbsp;2 demonstrating significant divergence between the two groups (p\u0026thinsp;=\u0026thinsp;0.047) with a calculated efficacy of 80.46% for the combination of ID and IN vaccination relative to ID vaccination alone. Since neither group reached 50% infection rate, median time to infection and the difference in median time to infections could not be calculated.\u003c/p\u003e \u003cp\u003eAlthough nasal swabs for SARS-CoV-2 genotyping were not collected post-infection, wastewater surveillance as reported by the Centers for Disease Prevention and State level Departments of Health for each geographic region \u003csup\u003e\u003cspan additionalcitationids=\"CR30\" citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e\u003c/sup\u003e was examined as an indirect measure of temporal genotype prevalence. Table\u0026nbsp;\u003cspan refid=\"Tab7\" class=\"InternalRef\"\u003e5\u003c/span\u003e shows the regional strain prevalence of SARS-CoV-2 variants circulating at the time that each infection was reported. Notably, as the study was conducted between May 2022 to late January 2023, only Omicron and Omicron subvariants were prevalent, although specific strains differed regionally and temporally.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab7\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePrevalence of SARS-CoV-2 variants at the time of each infection relative to geographic location of reported infection\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"19\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c12\" colnum=\"12\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c13\" colnum=\"13\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c14\" colnum=\"14\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c15\" colnum=\"15\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c16\" colnum=\"16\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c17\" colnum=\"17\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c18\" colnum=\"18\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c19\" colnum=\"19\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003e#\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eStudy arm\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eInfection Date\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSite\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eBA1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eBA1.1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eBA2\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eBA2.9\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c9\"\u003e \u003cp\u003eBA2.12\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c10\"\u003e \u003cp\u003eBA2.12.1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c11\"\u003e \u003cp\u003eBA2.75\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c12\"\u003e \u003cp\u003eBA4\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c13\"\u003e \u003cp\u003eBA4.6\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c14\"\u003e \u003cp\u003eBA5\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c15\"\u003e \u003cp\u003eBA5.1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c16\"\u003e \u003cp\u003eBA5.2\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c17\"\u003e \u003cp\u003eBA5.2.1\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c18\"\u003e \u003cp\u003eXBB1.5\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c19\"\u003e \u003cp\u003eBQ1\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10-Jun-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e14.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e4.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e \u003cp\u003e49.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e13.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e5.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c15\"\u003e \u003cp\u003e4.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c16\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c17\"\u003e \u003cp\u003e4.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22-Jun-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e14.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c8\"\u003e \u003cp\u003e4.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e \u003cp\u003e49.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e13.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e5.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c15\"\u003e \u003cp\u003e4.7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c16\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c17\"\u003e \u003cp\u003e4.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1-Jul-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e \u003cp\u003e13.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e18.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c13\"\u003e \u003cp\u003e5.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e24.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c15\"\u003e \u003cp\u003e18.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c16\"\u003e \u003cp\u003e6.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c17\"\u003e \u003cp\u003e12.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e12-Jul-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e \u003cp\u003e13.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e18.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c13\"\u003e \u003cp\u003e5.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e24.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c15\"\u003e \u003cp\u003e18.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c16\"\u003e \u003cp\u003e6.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c17\"\u003e \u003cp\u003e12.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e14-Jul-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e \u003cp\u003e13.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e18.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c13\"\u003e \u003cp\u003e5.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e24.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c15\"\u003e \u003cp\u003e18.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c16\"\u003e \u003cp\u003e6.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c17\"\u003e \u003cp\u003e12.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15-Jul-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e2.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e \u003cp\u003e12.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e3.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c13\"\u003e \u003cp\u003e9.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e65.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c16\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c17\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c18\"\u003e \u003cp\u003e3.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e23-Jul-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c10\"\u003e \u003cp\u003e13.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e18.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c13\"\u003e \u003cp\u003e5.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e24.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c15\"\u003e \u003cp\u003e18.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c16\"\u003e \u003cp\u003e6.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c17\"\u003e \u003cp\u003e12.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5-Aug-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e6.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e29.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c9\"\u003e \u003cp\u003e52.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c14\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c16\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c17\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c18\"\u003e \u003cp\u003e10.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8-Aug-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e8.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c13\"\u003e \u003cp\u003e8.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e21.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c15\"\u003e \u003cp\u003e21.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c16\"\u003e \u003cp\u003e7.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c17\"\u003e \u003cp\u003e30.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11-Aug-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e8.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c13\"\u003e \u003cp\u003e8.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e21.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c15\"\u003e \u003cp\u003e21.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c16\"\u003e \u003cp\u003e7.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c17\"\u003e \u003cp\u003e30.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e17-Aug-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e2.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e95.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c16\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c17\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e12\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18-Aug-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e8.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c13\"\u003e \u003cp\u003e8.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e21.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c15\"\u003e \u003cp\u003e21.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c16\"\u003e \u003cp\u003e7.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c17\"\u003e \u003cp\u003e30.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e13\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7-Oct-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e99.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c16\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c17\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18-Nov-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNE\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e1.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c11\"\u003e \u003cp\u003e4.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e2.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c13\"\u003e \u003cp\u003e3.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e63.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c16\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c17\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c19\"\u003e \u003cp\u003e27.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e15\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9-Dec-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNE\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e1.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c11\"\u003e \u003cp\u003e5.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e1.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e41.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c16\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c17\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c19\"\u003e \u003cp\u003e50.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11-Dec-22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNE\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e \u003cp\u003e1.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c11\"\u003e \u003cp\u003e5.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c12\"\u003e \u003cp\u003e1.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c14\"\u003e \u003cp\u003e41.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c16\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c17\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c19\"\u003e \u003cp\u003e50.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e17\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e26-Jan-23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e33.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e66.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c9\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c10\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c12\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c13\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c14\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c15\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c16\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c17\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c18\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c19\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"19\"\u003eStrain prevalence in Nebraska, Puerto Rico, and Maryland was estimated from data published by the local health departments or CDC \u003csup\u003e\u003cspan additionalcitationids=\"CR30\" citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e\u003c/sup\u003e. Presented are variants that constituted\u0026thinsp;\u0026ge;\u0026thinsp;1% of circulating strains. Study arms are as shown in Fig.\u0026nbsp;1; participants in study arm 2 were also administered GLS-5310 IN.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAssessment of potential factors that may have explained the lower incidence of SARS-CoV-2 incident infections in the ID plus IN group, other than vaccination administration route, was then examined. We first examined whether the rates of pre-study mRNA booster vaccination differed between the ID only and the ID plus IN groups, since this may afford protection against future infection. However, as noted above, a greater fraction of participants vaccinated ID only had received a pre-study mRNA booster vaccine compared to those in the ID plus IN group. We next considered whether primary vaccine type was a factor between treatment type, and found that the fraction who reported infection versus those who did not was not different (data not shown). Geographically, while fewer infections were reported for the Nebraska site relative to either Puerto Rico or Maryland sites (12.0%, versus 29.4% and 36.4% of participants, respectively), there was no apparent association that could explain a difference in infection rates. Finally, considering that there were 8 participants who discontinued the study prior to the final scheduled study visit, we examined whether unreported infections could have potentially affected the difference between groups. As shown in Fig.\u0026nbsp;2, only one person in ID plus IN group (study arm 2) terminated the study and did so late in clinical trial on day 328 just prior to the final study visit, whereas the other 7 persons who terminated early were in ID only groups and stopped participation at different time points throughout the study. Thus, if there were unaccounted SARS-CoV-2 infections, they would have had a greater likelihood of occurring in the ID only group and would have increased, not decreased, the difference between groups.\u003c/p\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eWe report here on the safety, toxicology, immunogenicity, and efficacy of the GLS-5310 DNA vaccine administered both ID with GeneDerm and ID plus IN to those previously vaccinated with either an mRNA or Ad26 vaccine against SARS-CoV-2. The CoV2-008 clinical trial represents the third study of the GLS-5310 vaccine and the first study that investigated the use of a DNA vaccine as part of a heterologous boost regimen. The study also represents, to our knowledge, the first use of a DNA vaccine administered IN to humans. This study complements our prior study that reported on GLS-5310 vaccination was later followed by mRNA booster vaccination which was well tolerated and immunogenic \u003csup\u003e\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAs in prior Phase 1 study of GLS-5310 given to vaccine-na\u0026iuml;ve participants \u003csup\u003e\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e, we find that GLS-5310 administered as a booster to those previously vaccinated with either an mRNA or Ad26 vaccine against SARS-CoV-2 was well tolerated. Those vaccinated IN reported a greater incidence of low-grade upper respiratory adverse reactions, but otherwise was tolerated without difficulty. Additionally, use of a GeneDerm device that applied a higher suction pressure of 80 kPa was tolerated equally well to use of a GeneDerm device that delivered 65 kPa of suction pressure, consistent with our prior pre-clinical experience (\u003csup\u003e\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e\u003c/sup\u003e and unpublished data). Safety of concurrent IN and ID administration of GLS-5310 was confirmed as part of a repeated dose GLP toxicology study that found no test article related toxicity that yielded results similar to a prior study that assessed GLS-5310 administered ID only to NZWR \u003csup\u003e\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn separate pre-clinical experiments in NZWR, GLS-5310 when administered IN induced high levels of serum IgA in rabbits, with concurrent IN and ID vaccination yielding higher IgA and more persistent responses relative to IN vaccination alone. Serum IgG responses were similar between ID and IN plus ID vaccinated groups, and essentially non-detectable for animals vaccinated IN alone, the latter as reported by others \u003csup\u003e\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e,\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e\u003c/sup\u003e. Importantly, these studies found that IN administration with a DNA vaccine protected animals from nasal challenge with influenza and gastrointestinal challenge from rotavirus \u003csup\u003e\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e,\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eGLS-5310 administered as a single booster was immunogenic inducing 1.5- to 4-fold increases in serum IgG titers and up to 14.4-fold increases in T cell responses by ELISpot. Notably, both antibody and T cell responses typically remained elevated throughout the 48-week final study. We observed no difference in immune responses relative to route of vaccine administration (ID only versus ID plus IN) or with use of GeneDerm devices with various pressure settings (65 kPa versus 80 kPa) or time that suction was delivered (15 versus 30 seconds). Consistent with other studies \u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u003c/sup\u003e, study participants who had been previously vaccinated with a primary mRNA vaccine series had higher baseline antibody titers but a smaller increase in post-vaccination titers relative those who had been vaccinated with the Ad26.CoV.S vaccine. Notably, the high post-vaccination T cell responses that we observed were greater than the 2 to 3-fold post-vaccination increase seen for other heterologous primary series \u0026ndash; boost vaccine combinations \u003csup\u003e\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e\u003c/sup\u003e. Importantly, both B and T cell increases were persistent, a beneficial effect for potential long-term protection.\u003c/p\u003e \u003cp\u003eImportantly, the combination of IN and ID vaccination appeared to be protective against incident SARS-CoV-2 infection as only 1 (5.9%) of the 17 participants who were vaccinated IN plus ID reported infections versus 16 (30.2%) of the 53 participants vaccinated ID only, p\u0026thinsp;=\u0026thinsp;0.042 by chi-square analysis, with a calculated vaccine efficacy of 80.5%. Separation between groups was detectable within 2 weeks post-boost vaccination. The majority of infections occurred within 180 days of vaccination with GLS-5310 and only one additional infection at study day 230 days implying protection for at least 6 months and potentially for almost 8 months. However, we were unable to demonstrate any immunologic differences between groups, including attempts to document differences in IgA responses.\u003c/p\u003e \u003cp\u003eThe apparent protection against incident SARS-CoV-2 infection was even more notable considering that the clinical trial was conducted between May 2022 and July 2023 when Omicron variants of concern (VOC) had replaced earlier, vaccine susceptible strains \u003csup\u003e\u003cspan additionalcitationids=\"CR30\" citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e\u003c/sup\u003e. During this time, variant strain emergence was clearly dynamic as multiple Omicron strains were circulating at each clinical site at varied over time. The observed protection against a variety of Omicron VOC is notable since GLS-5310 vaccine was designed based on a consensus of ancestral strains circulating early in the pandemic \u003csup\u003e\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eTo our knowledge, this is the first clinical trial that has shown potential protection from a nasal vaccine against incident SARS-CoV-2 infection due to Omicron VOC strains. A Phase 3 study of the dNS1-RBD vaccine, created by inserting the codon-optimized coding region of the receptor binding domain (RBD) of Wuhan strain SARS-CoV-2 into an NS1 deleted influenza to create a live-attenuated nasal vaccine \u003csup\u003e\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e\u003c/sup\u003e, in vaccine-na\u0026iuml;ve, previously uninfected individuals conducted during a time when Omicron VOCs were circulating yielded a vaccine efficacy against symptomatic infection of 28.2% (95% CI 3.4\u0026ndash;46.6) \u003csup\u003e\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e\u003c/sup\u003e. A second, Phase 1, study also during a period when Omicron VOCs were prevalent evaluated the safety and immunogenicity of the ChAdOx1 nCoV19 viral-vectored vaccine given IN included a small booster substudy for which vaccine was administered to those previously vaccinated with either the ChAdOx1 (n\u0026thinsp;=\u0026thinsp;6) or the BNT162b2 mRNA (n\u0026thinsp;=\u0026thinsp;6) vaccines \u003csup\u003e\u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e\u003c/sup\u003e. During the approximate 4-month follow-up period, 4 (33.3%) persons in the substudy, including 1 in the ChAdOx1 group and 3 in the BNT162b2 group developed incident SARS-CoV-2 infection. A third clinical trial also performed during the Omicron outbreak, a Phase 3 study of the BBV154 Ad26 vaccine given as an IN booster to those who previously received two doses of BBV154 reported safety data but had not yet completed efficacy analysis at the time of the preliminary publication \u003csup\u003e\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eBy comparison, protective efficacy of mRNA IM boost vaccination against Omicron infection appears to be high initially but rapidly wanes. A study based on reported rates of infection within the US Veterans Affairs system calculated vaccine efficacy of 87% within the first two months post-boost that decreased to 66% by five months \u003csup\u003e\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e\u003c/sup\u003e. And a large Israeli study reported vaccine efficacy of 53.4% within the month after boost vaccination that declined to 16.5% by three months \u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e while a fourth dose (or second booster) was reported with a vaccine efficacy of 52% within the five weeks post-vaccination that declined to -2% at 15 to 26 weeks \u003csup\u003e\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eWhether the apparent protection in our study was B or T cell related is unknown. Others have shown that among those with incident SARS-CoV-2 infection, lower nasal viral loads and more rapid viral clearance are correlated with greater systemic T cell responses \u003csup\u003e\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e\u003c/sup\u003e. Notably, T cell immunity was observed at the time of SARS-CoV-2 infection diagnosis, i.e. within days of exposure \u003csup\u003e\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e\u003c/sup\u003e. Moreover, the same group demonstrated the formation of nasal mucosal tissue resident memory T cells and memory B cells and germinal centers among those with repeat SARS-CoV-2 exposure \u003csup\u003e\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e\u003c/sup\u003e. Whether nasal vaccination in our study would thus induce protective local T cell responses is as yet unknown and of interest not only for SARS-CoV-2, but any viral pathogen for which the upper airway is the site of initial colonization and infection.\u003c/p\u003e \u003cp\u003eWhile results in this study showed apparent protection against incident SARS-CoV-2 infection, the study has a number of limitations. First and foremost, the results showing protection afforded by the combination of IN plus ID vaccination represent an ad-hoc analysis of the CoV2-008 clinical trial was not designed to assess the protective efficacy of IN vaccination with GLS-5310 and the small sample size of 70 persons limits generalization. Second, we were unable to detect group or sub-group differences in immune responses that correlated the apparent clinical difference. Also, while IN plus ID vaccination appeared to be protective against symptomatic infection from a multiplicity of Omicron variants, this observation is predicated on reported prevalences of circulating variants based on reports of wastewater studies \u003csup\u003e\u003cspan additionalcitationids=\"CR30\" citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e\u003c/sup\u003e and could not be confirmed since infecting isolates were not genotyped. Finally, it is possible that additional cases of Omicron variant infection occurred but were completely asymptomatic, and therefore never diagnosed as the rate of asymptomatic infection related to Omicron has been reported to range between 25 and 32% in two meta-analyses \u003csup\u003e\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e,\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e\u003c/sup\u003e while a South African vaccine study among HIV positive individuals found that 23% of enrollees had asymptomatic infection detected by nasal swab at enrollment \u003csup\u003e\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn conclusion, we have shown further evidence of the safety and immunogenicity of the GLS-5310 DNA vaccine against SARS-CoV-2 when administered ID using the GeneDerm suction device. Post-boost responses were consistent with other studies of heterologous vaccine regimens and importantly we found that immune responses were persistent as we have previously reported in vaccine-na\u0026iuml;ve participants \u003csup\u003e\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e. Further, we found that IN administration of the GLS-5310 vaccine was safe and may have been effective in preventing incident SARS-CoV-2 infection. While the study has many limitations, it highlights the potential value for combination of ID and IN administration for this and other applications.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eConflicts of Interest:\u003c/h2\u003e \u003cp\u003eCCR, DK, MG, SBK, SKM, YKP, JNM are full time employees of GeneOne Life Science, Inc. the developer of the GLS-5310 vaccine\u003c/p\u003e \u003ch2\u003eAcknowledgements\u003c/h2\u003e \u003cp\u003eThe study participants are gratefully acknowledged. We would also like to acknowledge Catalyst Clinical Research for their expertise, assistance, and support during study initiation, conduct, and analysis.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBaric RS. Emergence of a highly fit SARS-CoV-2 variant. N Engl J Med 2020 383(27): 2684\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePlante JA, Liu Y, Liu J, et al. Spike mutation D614G alters SARS-CoV-2 fitness and neutralization susceptibility. bioRxiv online 2020 Sep 2:2020.09.01.278689 (Preprint)\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang Q, Iketani S, Li Z, et al. Alarming antibody evasion properties of rising SARS-CoV-2 BQ and XBB subvariants. Cell 2023 186(2):279\u0026ndash;286.e8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBarda N, Dagan N, Cohen C, et al. 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Clin Infect Dis 2022 75(1): e289-e92.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"nature-portfolio","isNatureJournal":true,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"","title":"Nature Portfolio","twitterHandle":"","acdcEnabled":false,"dfaEnabled":false,"editorialSystem":"ejp","reportingPortfolio":"","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-6406233/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6406233/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eWe evaluated the safety and immunogenicity of boost vaccination with the GLS-5310 SARS-CoV-2 DNA vaccine to those previously vaccinated with the Ad26.S.CoV2, BNT162b2, or mRNA-1273 vaccines. GLS-5310 was administered intradermally (ID) and followed by application of suction using the GeneDerm device, or ID as well as intranasally (IN) by nasal atomizer. GLS-5310 vaccination was well tolerated. With respect to primary vaccine type, boost vaccination induced a 1.5- to 4-fold increase in antibody titers, up to a 14.4-fold increase in T cell responses by ELISpot. Incident SARS-CoV-2 infections, during a period of Omicron prevalence, were reported for 24.2% of participants: 1 of 17 (5.9%) vaccinated ID plus IN versus 16 of 53 (30.2%) vaccinated ID only, p\u0026thinsp;=\u0026thinsp;0.042 (chi-square analysis). This first ever trial of a DNA vaccine administered IN plus ID showed potential protection against incident SARS-CoV-2 Omicron infection.\u003c/p\u003e \u003cp\u003eNCT Clinical Trial number: NCT05182567\u003c/p\u003e","manuscriptTitle":"Prevention of incident SARS-CoV-2 infection through combined intranasal and intradermal administration of the GLS-5310 DNA vaccine during the Omicron outbreak","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-05 11:34:14","doi":"10.21203/rs.3.rs-6406233/v1","editorialEvents":[],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"nature-communications","isNatureJournal":true,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"NCOMMS","sideBox":"Learn more about [Nature Communications](http://www.nature.com/ncomms/)","snPcode":"","submissionUrl":"https://mts-ncomms.nature.com/","title":"Nature Communications","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature Communications","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"39edca54-2343-4334-aa07-14c461c858a9","owner":[],"postedDate":"May 5th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[{"id":47153265,"name":"Health sciences/Medical research/Drug development"},{"id":47153266,"name":"Biological sciences/Drug discovery/Drug delivery"},{"id":47153267,"name":"Health sciences/Diseases/Infectious diseases/Viral infection"}],"tags":[],"updatedAt":"2025-05-05T11:34:14+00:00","versionOfRecord":[],"versionCreatedAt":"2025-05-05 11:34:14","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6406233","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6406233","identity":"rs-6406233","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}