Efficacy of the NVX-CoV2373 COVID-19 Vaccine in Patients With vs Without HIV

Patients with HIV infection without prior COVID-19 exposure had attenuated humoral responses to COVID-19 vaccination with NVX-CoV2373. These findings, from randomized, observer-blinded, multicenter, placebo-controlled phase 2A/B trial, were published in The Lancet HIV.

This trial was conducted at 16 centers in South Africa between August and November 2020. Adult patients with (n=244) and without (n=4164) HIV-1 infection were randomly assigned in a 1:1 fashion to receive either 2 doses of NVX-CoV2373 (n=2211), a recombinant spike protein vaccine or placebo (n=2197). This coprimary study evaluated the safety and reactogenicity of NVX-CoV2373 vaccination among patients with and without HIV infection on the basis of baseline SARS-CoV-2 status.

Among patients in the positive and negative HIV groups, the median age was 38.0 (range, 20-60) and 27.0 (range, 18-84) years, 27.0% and 59.0% were men, 100% and 95.0% were Black, and 34.0% and 34.1% were positive for COVID-19 infection at baseline, respectively.

Solicited systemic adverse events (AEs) of pain, tenderness, headache, and fatigue were more common among patients who received NVX-COV2373 vs those who received placebo. In addition, the occurrence of AEs among patients with and without HIV infection following vaccination did not differ significantly on the basis of baseline COVID-19 status.

Stratified by HIV status, serum anti-spike immunoglobulin (Ig) G titers were decreased among patients with vs without HIV infection (geometric mean titer [GMT], 2068.5 vs 3253.5 endotoxin units [EU]/mL). After stratification of these patients by baseline COVID-19 status, those who were previously exposed to the infection had similar IgG titers vs those without HIV infection (GMT, 19,240 vs 21,137.5 EU/mL). Between patients in the positive vs negative HIV groups without prior COVID-19 exposure, IgG titers significantly differed (GMT, 508.6 vs 1195.3 EU/mL).

At day 35, patients in the positive and negative HIV groups who received the vaccine had geometric mean fold rises (GMFRs) of 87.8 and 162.4, respectively. Stratified by COVID-19 status, patients in the positive and negative HIV groups who were exposed to COVID-19 had similar GMFR (53.1 vs 56.1, respectively). Between patients in the positive vs negative HIV groups without prior exposure, GMFRs significantly differed (123.0 vs 283.7).

Further analysis of patients without prior COVID-19 exposure showed that the IgG titer seroresponse rate at day 35 after NVX-CoV2373 vaccination was increased among those in the negative vs positive HIV groups (91.0% vs 72.4%).

Similar results were noted for angiotensin-converting enzyme 2 (ACE-2) receptor-binding inhibition titers. At day 35, the seroresponse rate among patients without prior COVID-19 exposure was increased among those in the negative vs positive HIV groups (83.6% vs 70.5%).

These findings may be generalizable among only patients with HIV infection receiving antiretroviral therapy.

According to the researchers, “[these] results indicate the need to investigate alternative dosing approaches in SARS-CoV-2-naïve people living with HIV-1…”

Disclosure: Multiple authors declared affiliations with industry. Please see the original reference for a full list of disclosures.

Reference

Madhi SA, Moodley D, Hanley S, et al. Immunogenicity and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine in people living with and without HIV-1 infection: a randomised, controlled, phase 2A/2B trial. Lancet HIV. 2022;5:e309-22. doi:10.1016/S2353-3018(22)00041-8