RESUMO
BackgroundIt has been proven that inactivated COVID-19 vaccines are safe and effective in general population with intact immunity. However, their safety and immunogenicity have not been demonstrated in people living with HIV (PLWH). Methods42 HIV-1 infected individuals who were stable on cART and 28 healthy individuals were enrolled in this study. Two doses of an inactivated COVID-19 vaccine (BIBP-CorV) were given 4 weeks apart. The safety and reactogenicity of the vaccine were evaluated by observing clinical adverse events and solicited local and systemic reactions. Humoral responses were measured by anti-spike IgG ELISA and surrogate neutralization assays. Cell-mediated immune responses and vaccine induced T cell activation were measured by flow cytometry. FindingsAll the HIV-1 infected participants had a CD4+ T cell count of above 200 cells/L both at baseline and 4 weeks after vaccination. No solicited adverse reaction was observed among all participants. Similar binding antibody, neutralizing antibody and S protein specific T cell responses were elicited in PLWH and healthy individuals. Further analyses showed that PLWH with low baseline CD4+/CD8+ T cell ratios (<0{middle dot}6) generated lower antibody responses after vaccination than PLWH with medium (0{middle dot}6[~]1{middle dot}0) or high ([≥]1{middle dot}0) baseline CD4+/CD8+ T cell ratios (P<0{middle dot}01). The CD3+, CD4+ and CD8+ T cell counts of PLWH decreased significantly after vaccination, but it did not lead to any adverse clinical manifestation. Moreover, we found that the general burden of HIV-1 among the PLWH cohort decreased significantly (P=0{middle dot}0192) after vaccination. And the alteration of HIV-1 viral load was not significantly associated with the vaccine induced CD4+ T cell activation. InterpretationOur data demonstrate that the inactivated COVID-19 vaccine is safe and immunogenic in PLWH who are stable on cART with unsuppressed CD4 counts. FundingThis work was funded by the National Natural Science Foundation of China (Grant No. 81971559, 82041010). Research in contextO_ST_ABSEvidence before this studyC_ST_ABSThe safety and efficacy of inactivated COVID-19 vaccines have been validated in general population with intact immunity. However, their safety and immunogenicity have not been demonstrated in people living with HIV (PLWH). Added value of this studyOur study provides the first evidence to show humoral and cellular immune responses to an inactivated vaccine in PLWH who have been stable on cART with good CD4 cell counts. We found that participants with HIV-1 generated antibody and T cell responses comparable with those of healthy individuals after two-dose vaccination. The baseline CD4/CD8 ratios while not the absolute CD4+ T cell counts were shown to be associated with the magnitudes of vaccine induced antibody responses. Moreover, we showed that the vaccine induced T cell activation did not increase the viral burden in PLWH on cART. On the contrary, the levels of plasma HIV-1 RNA decreased among a significant percentage of PLWH. Implications of all the available evidenceOur data demonstrate that the inactivated COVID-19 vaccine is safe and immunogenic in PLWH who are stable on cART with unsuppressed CD4 counts and indicate that this vaccine might be protective and efficacious against COVID-19 for people with HIV.
