Immunogenicity and safety of a Recombinant gE-Fc Fusion Protein Subunit Vaccine for Herpes Zoster in Adults ≥50 Years of Age: a randomised, active-controlled, non-inferiority trial

Immunogenicity and safety of a Recombinant gE-Fc Fusion Protein Subunit Vaccine for Herpes Zoster in Adults ≥50 Years of Age: a randomised, active-controlled, non-inferiority trial | 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 Immunogenicity and safety of a Recombinant gE-Fc Fusion Protein Subunit Vaccine for Herpes Zoster in Adults ≥50 Years of Age: a randomised, active-controlled, non-inferiority trial Jing-Xin Li, Peng-Fei Jin, Ya-Ru Quan, Shi-Xin Xiu, Xian-Min Jiang, and 19 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6370541/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 Background The licensed adjuvanted recombinant glycoprotein E (gE) subunit vaccine (HZ/su) is highly efficient against herpes zoster (HZ). We compared the immunogenicity and safety of a novel gE-Fc fusion protein subunit vaccine candidate (LZ901) with HZ/su. Methods This was a randomised, active-controlled, non-inferiority trial conducted in Wuxi, China, involving healthy adults aged 50 years and older who had not previously received a HZ vaccine. Eligible participants were randomly assigned (1:1) to receive two doses of LZ901 (30-day interval) or HZ/su (60-day interval). This study was partially blinded, with all participants and investigators without access to the vaccines were masked till 30 days post-first dose, while the laboratory testing personnel remained blinded for the entire trial. Primary outcomes were the proportions of participants with CD4²⁺/CD8²⁺ T-cell responses (defined as co-expression of ≥2 activation markers: IFN-γ, IL-2, TNF-α, or CD40L) 30 days post-second dose. Non-inferiority of LZ901 to HZ/su was determined when the differences of proportions between LZ901 and HZ/su > -10% non-inferiority margin. This study is registered with chictr.org, ChiCTR2300079076. Findings Between December 25 and 29, 2023, we screened 357 individuals for eligibility. Of them, 300 were eligible and randomly allocated to receive either LZ901 vaccine (n=151) or HZ/su vaccine (n=149). LZ901 met non-inferiority criteria for both CD42⁺ and CD82⁺ T-cell responses compared to HZ/su. Participants receiving LZ901 demonstrated higher proportions of responders with at least two positive cytokines CD4²⁺ T-cell (96.5% [136/141] vs 79.4% [108/136]; p<0.0001) and the CD8²⁺ T-cell (69.5% [98/141] vs 22.8% [31/136]; p<0.0001) than participants receiving HZ/su did. Adverse reactions were significantly less frequently reported by LZ901 recipients (41.1% [62/151] vs 87.9% [131/149]; p<0.0001) than those reported by HZ/su recipients, as well as grade 3 adverse reactions (0.7% [1/151] vs 6.0% [9/149]). Interpretation LZ901 induced superior immunogenicity in terms of cellular immune responses than HZ/su did in adults ≥50 years, with a better safety profile. Our findings supported LZ901 as a promising candidate vaccine for HZ prevention. Funding National Key Research and Development Program of China, Medical Research Program of Jiangsu Health Commission and Beijing Luzhu Biotechnology Co., Ltd. Health sciences/Diseases/Infectious diseases/Viral infection Health sciences/Medical research/Clinical trial design/Randomized controlled trials Full Text Additional Declarations Yes there is potential Competing Interest. Xian-Min Jiang, Jian Kong and Ling Peng are employees of Beijing Luzhu Biotechnology Co., Ltd. and participated in study design, but had no role in data collection, data analysis, data interpretation, or writing of the report.All the other authors declare no competing interests. Supplementary Files 3CONSORTChecklist.pdf CONSORT Checklist 4ProtocolV1.1.pdf Protocol 2Supplementary.pdf Supplementary 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. We do this by developing innovative software and high quality services for the global research community. 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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-6370541","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":442912964,"identity":"d4f5afbd-b947-4768-941f-ddd8101db5be","order_by":0,"name":"Jing-Xin 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analysis, data interpretation, or writing of the report.All the other authors declare no competing interests.","formattedTitle":"Immunogenicity and safety of a Recombinant gE-Fc Fusion Protein Subunit Vaccine for Herpes Zoster in Adults ≥50 Years of Age: a randomised, active-controlled, non-inferiority trial","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"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-6370541/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6370541/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eThe licensed adjuvanted recombinant glycoprotein E (gE) subunit vaccine (HZ/su) is highly efficient against herpes zoster (HZ). We compared the immunogenicity and safety of a novel gE-Fc fusion protein subunit vaccine candidate (LZ901) with HZ/su.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e This was a randomised, active-controlled, non-inferiority trial conducted in Wuxi, China, involving healthy adults aged 50 years and older who had not previously received a HZ vaccine. Eligible participants were randomly assigned (1:1) to receive two doses of LZ901 (30-day interval) or HZ/su (60-day interval). This study was partially blinded, with all participants and investigators without access to the vaccines were masked till 30 days post-first dose, while the laboratory testing personnel remained blinded for the entire trial. Primary outcomes were the proportions of participants with CD4²⁺/CD8²⁺ T-cell responses (defined as co-expression of ≥2 activation markers: IFN-γ, IL-2, TNF-α, or CD40L) 30 days post-second dose. Non-inferiority of LZ901 to HZ/su was determined when the differences of proportions between LZ901 and HZ/su \u0026gt; -10% non-inferiority margin. This study is registered with chictr.org, ChiCTR2300079076.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFindings\u003c/strong\u003e Between December 25 and 29, 2023, we screened 357 individuals for eligibility. Of them, 300 were eligible and randomly allocated to receive either LZ901 vaccine (n=151) or HZ/su vaccine (n=149). LZ901 met non-inferiority criteria for both CD42⁺ and CD82⁺ T-cell responses compared to HZ/su. Participants receiving LZ901 demonstrated higher proportions of responders with at least two positive cytokines CD4²⁺ T-cell (96.5% [136/141] vs 79.4% [108/136]; p\u0026lt;0.0001) and the CD8²⁺ T-cell (69.5% [98/141] vs 22.8% [31/136]; p\u0026lt;0.0001) than participants receiving HZ/su did. Adverse reactions were significantly less frequently reported by LZ901 recipients (41.1% [62/151] vs 87.9% [131/149]; p\u0026lt;0.0001) than those reported by HZ/su recipients, as well as grade 3 adverse reactions (0.7% [1/151] vs 6.0% [9/149]). \u003cstrong\u003eInterpretation\u003c/strong\u003e LZ901 induced superior immunogenicity in terms of cellular immune responses than HZ/su did in adults ≥50 years, with a better safety profile. Our findings supported LZ901 as a promising candidate vaccine for HZ prevention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;Funding \u003c/strong\u003eNational Key Research and Development Program of China, Medical Research Program of Jiangsu Health Commission and Beijing Luzhu Biotechnology Co., Ltd.\u003c/p\u003e","manuscriptTitle":"Immunogenicity and safety of a Recombinant gE-Fc Fusion Protein Subunit Vaccine for Herpes Zoster in Adults ≥50 Years of Age: a randomised, active-controlled, non-inferiority trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-16 03:57:00","doi":"10.21203/rs.3.rs-6370541/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":"998b92fe-7a62-4da9-9af6-4b942f8b29c5","owner":[],"postedDate":"April 16th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[{"id":47154569,"name":"Health sciences/Diseases/Infectious diseases/Viral infection"},{"id":47154570,"name":"Health sciences/Medical research/Clinical trial design/Randomized controlled trials"}],"tags":[],"updatedAt":"2025-07-30T15:46:16+00:00","versionOfRecord":[],"versionCreatedAt":"2025-04-16 03:57:00","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6370541","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6370541","identity":"rs-6370541","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}