ABSTRACT
Background: To analyze the efficacy and safety of SARS-CoV-2 inactivated vaccine in people living with HIV (PLWH).Methods: A total of 143 PLWH were included in the study. All patients were confirmed with HIV-1 infection. We also enrolled 50 healthy individuals vaccinated with two doses of SARS-CoV-2 vaccine as controls. A commercially available magnetic chemiluminescence enzyme immunoassay kit was used to detected serum IgG and IgM against SARS-CoV-2.Findings: Serum levels of SARS-CoV-2-specific IgG were significantly higher in the control group than in the PLWH group (P=0.001). Overall, 76% of individuals in the control group achieved IgG seroconversion after vaccination compared with 58% in the PLWH group (P=0.024). The time after vaccination in IgG seronegative PLWH was significantly longer compared with PLWH with IgG seropositive (43.38 ± 34.96 vs 30.27 ± 20.12 days, P=0.005). In PLWH with IgG seropositivity, CD4+ T cell counts before antiretroviral therapy (ART) (P=0.015) and at IgG detection (P<0.001) were higher. Multivariable analysis indicated CD4+ T cells at IgG detection (OR=1.004, P=0.006) and time after vaccination (OR=0.977, P=0.014) were independently associated with humoral response in PLWH after vaccination. Neutralizing antibody (NeuAb) titers in PLWH against wild type SARS-CoV-2 were similar compared with the Control group (P=0.160). The proportion of seropositive NeuAb against wild type SARS-CoV-2 were also similar (95% in Control group vs 97% in PLWH group, P=0.665). Similar results were obtained when NeuAb were detected against the delta variants with similar titers (P=0.355) and with similar proportion of humoral response (P=0.588). All side effects observed in our study were mild and self-limiting. There was no significant difference in occurrence of side effects in the control and PLWH groups. Interpretation: The inactivated COVID-19 vaccine appears to be safe with good immunogenicity in PLWH.Funding: This study was supported by Clinical Research Startup Program of Southern Medical University by High-level University Construction Funding of Guangdong Provincial Department of Education (No. LC2016PY003).Declaration of Interest: None of the authors have competing interests to disclose.Ethical Approval: The study was performed in accordance with the Declaration of Helsinki and was approved by the Institutional Ethics Committee of Nanfang Hospital (NFEC-2021-178).