Phase 2a Trial to Evaluate Safety and Immunogenicity of COVID-19 Vaccine Strategies in HIV-infected/Uninfected Adults.

Summary

This is a multicenter, randomized, observer blind clinical trial. A total of 750 evaluable HIV-infected (660) and HIV-uninfected (90) adult participants meeting all entry criteria (all inclusion and no exclusion criteria) will be enrolled in 3 treatment strategies in 3 participant groups dependent on prior vaccination with a single dose Janssen (Group 1), 2 doses of Pfizer (Group 2) or no prior COVID-19 vaccination with evidence of prior SARS-CoV-2 infection (Group 3) .A total of 300 participants per group will be enrolled in Groups 1 and 2 (255 HIV-infected and 45 HIV-uninfected per group), and 150 HIV-infected, unvaccinated participants in Group 3. Each treatment regimen (Vaccine Arm: A, B or C) will evaluate 250 participants. Groups 1 and 2 will enrol 85 HIV-infected and 15 HIV-uninfected per vaccine arm.

Timeline

Start

2022-07-25

Primary completion

2024-06-30

Completion

2024-12-31

Publications

• Govender V, Reddy T, Maenetje P, Beattie T, Adonis T, Nielson T, Moodley J, Mdluli J, Bhoola A, Angelo S, Panchia R, Mngadi K, Innes C, Brumskine W, Mlotshwa M, Nhlangulela L, Ncube I, Moyo-Gwete T, Moore PL, Keeton RS, Burgers W, Kumar K, Garg N, Tripathi A, Sayed S, Matsimela K, Mchunu N, Wallis R, Edward VA, Churchyard GJ; COVID-19 Vaccine Strategies study group. Safety and immunogenicity of a single dose of Ad26.COV2.S, BNT162b2, or SARS-CoV-2-rS-protein-nanoparticle in previously vaccinated and unvaccinated adults living with and without HIV in South Africa: a phase 2a randomised, observer-blind trial. Lancet HIV. 2026 Mar;13(3):e163-e175. doi: 10.1016/S2352-3018(25)00275-9. Epub 2026 Feb 11.

Drugs

Indications