Safety and Immunogenicity of CoronaVac in People Living with HIV

Background: People living with HIV (PLWH) may have a poor or delayed response to vaccines, mainly when CD4+ T cell counts are low. There are limited data concerning the safety and immunogenicity of COVID-19 vaccines in PLWH.Methods: This prospective controlled study evaluated the safety and immunogenicity of the SARS-CoV-2 inactivated vaccine CoronaVac in PLWH compared with controls with no known immunosuppression. Immunogenicity was assessed with SARS-CoV-2 IgG seroconversion (SC), neutralizing antibodies (NAb) activity, and factor increase in IgG geometric mean titers (FI-GMT). We also investigated if levels of CD4+ T cell counts (< or ≥500 cells/mm3) were associated with CoronaVac immunogenicity.Findings: 511 participants (215 PLWH and 296 controls) were eligible for the immunogenicity analysis. At vaccine completion (D69), although the percentage of participants with SC and NAb positivity was high for both PLWH and controls, it was somewhat lower in PLWH. CD4+ T cell was identified as a relevant factor for immunogenicity, with lower SC and NAb positivity in PLWH with CD4+ counts <500 cells/mm3 compared to those with ≥500 cells/mm3. In a multivariable logistic regression model for NAb positivity after a complete two-dose regimen adjusted for age and sex, compared with PLWH with a CD4+ T cell count <500/mm3, those with CD4+ counts ≥500/mm3 had 2·26 times the odds of having positivity in NAb activity (95% CI 1·18-4·32; p=0·014), whereas controls had 3·21 times the odds of this outcome. No serious adverse reactions were reported during the study.Interpretation: Immunogenicity following CoronaVac in PLWH seems robust but reduced compared with controls; PLWH with CD4+ counts <500/mm 3 are at increased risk for a blunted antibody response following vaccination.Funding: Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP); Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq); and B3 - Bolsa de Valores do Brasil.Declaration of Interest: EGK is the Principal Investigator for the CoronaVac phase 3 clinical trial at University of Sao Paulo. VIAS is the Principal Investigator for the Janssen COVID-19 vaccine phase 3 clinical trial at University of Sao Paulo. INCOMPLETE, MISSING SOME AUTHORS FROM DOIEthical Approval: The national and local ethics committees approved the study.