Safety Profile of COVID-19 Vaccines in HIV Patients Undergoing ART and Their Impact on Immune Recovery and HIV Reservoirs

Abstract Background: While some studies have reported the impact of COVID-19 vaccines on immune recovery and human immunodeficiency virus (HIV) reservoirs in persons living with HIV (PLWH), their findings remain inconsistent. Furthermore, limited data exist on the safety of multiple COVID-19 vaccines among PLWH. This study aimed to investigate the safety of heterological COVID-19 vaccine administration in PLWH receiving antiretroviral treatment (ART) and its effects on HIV reservoirs and immune recovery. Such an investigation can help provide a basis for vaccinations against COVID-19 in PLWH. Methods: In this cross-sectional study, PLWH receiving ART were recruited from the outpatient clinic of the Department of Infectious Diseases at the Fifth Medical Center of the Chinese PLA General Hospital from September 1, 2021 to December 31, 2021. Fifty-three PLWH receiving ART were vaccinated against COVID-19, with 35 receiving an inactivated vaccine (IN group) and 18 receiving a recombinant protein (CHO cells) vaccine (CHO group) as the third dose. We assessed the changes in liver and kidney functions, blood lipids, and other laboratory parameters at 0, 1, 2, 4, 7, 8, 10, and 13 months after the first vaccination dose. We also monitored CD4 + and CD8 + T cell counts using flow cytometry at 0, 1, 2, 4, 7, 8, 10, and 13 months after the first vaccination dose, as well as levels of cell-associated HIV DNA (CA HIV DNA) and cell-associated HIV RNA (CA HIV RNA) in peripheral blood using the corresponding quantitative detection kits at 0, 2, and 8 months after the first vaccination dose. Results: No severe adverse events related to either type of COVID-19 vaccine were observed in HIV patients, irrespective of their CD4 + T cell levels. Both the IN and CHO groups showed significant increases in CD4 + T cell counts during follow-up, CD4 + T cells increased from 438 ± 45 cells/μL to 557 ± 48 cells/μL in the CHO group, while in the IN group, it increased from 448 ± 34 cells/μL to 572 ± 39 cells/μL (both P < 0.001). CA HIV DNA initially decreased and then increased in both groups. CA HIV RNA levels showed significantly decreased in both group after three doses of vaccination ( P < 0.01 in CHO group and P < 0.001 in IN group). CD8 + T cells increased from 608 ± 77 cells/μL to 812 ± 116 cells/μL in the CHO group ( P < 0.01), while in the IN group, it increased from 702 ± 71 cells/μL to 852 ± 68 cells/μL( P < 0.001) from baseline to the 13 month of following up. Conclusion: Our data suggest that the SARS-CoV-2 booster vaccine is safe for PLWH on ART, although it may affect HIV reservoirs and CD8 + T cell counts.