ABSTRACT
Background: The immunogenicity and safety of mRNA-based vaccination in people living with HIV have yet to be clarified. We aimed to describe the impact of SARS-CoV-2 mRNA vaccination on safety, HIV-RNA control, and humoral immune responses after two doses of vaccine. Methods: From January 2021 to April 2021, vaccination with mRNA1273 (Moderna) and BNT162b2 (BioNTech/Pfizer) was offered to every individual with HIV registered at our institution who fulfilled vaccination criteria and consented to routine vaccination. HIV-1 RNA levels and anti-SARS-CoV-2 S total Ig (Elecsys®, Roche Diagnostics, Rotkreuz, Switzerland) were measured at the time of the first and second doses, 30 days later, and at 6 months after the first dose. Results: The study sample included 131 individuals (median age: 54 years [interquartile range (IQR): 47-60.5]);male: 70.2%;median baseline CD4-T cell: 602 cells/μ l [IQR: 445.0-825.5]). HIV viral load data were collected for 129 patients at the time of the first dose (M0) and 30 days later (M1);for 124 patients, 30 days after the second dose (M2);and for 42 patients, 6 months after the first dose (M6). Twenty (15.5%) of 129 patients had detectable HIV-1 RNA (>20 copies/ml;IQR: 24.0-43.5) at M0, 13/129 (10.1%) at M1 (among which 5 were newly detected), 15/124 (12.1%) at M2 (among which 4 were newly detected), and 6/42 (14.3%) at M6. HIV-RNA levels returned below the detection threshold of 20 copies/mL at the subsequent measure. All analyzed patients showed a positive anti-SARS-CoV-2 S Ig after vaccination with geometric mean titers (GMT) of 131.8 U/ml (95% CI: 130.4-133.2) 30 days after the first dose and 2003.4 U/ml (95% CI: 2002.3-2004.4) 30 days after the second dose. Six months after the first dose, 75/131 patients were analyzed, and they were all still positive for anti-SARS-CoV-2 S Ig, with GMT of 1132.2 U/ml (95% CI: 1131.0-1133.4). We found no statistical significance in anti-SARS-CoV-2 S Ig titers between patients with detectable and undetectable HIV-1 RNA. No serious adverse effects were reported. Conclusion: In a patient population on effective antiretroviral drugs, only minor or transient effects of mRNA vaccines on HIV-1 RNA levels were observed. All patients developed anti-SARS-CoV-2 S total antibodies after two-dose vaccination and antibodies were detectable in all analyzed patients 6 months after the first dose.