Phase 2a Trial to Evaluate Safety and Immunogenicity of COVID-19 Vaccine Strategies in HIV-infected/Uninfected Adults.
Status:
Recruiting
Trial end date:
2023-07-31
Target enrollment:
Participant gender:
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.