Assessment of COVID-19 among participants in an ongoing phase 1 HIV vaccine trial (HIV CORE 006) in Eastern and Southern Africa

Mumba-Mwangelwa’s research question is, “Will the prevailing COVID-19 pandemic have an impact on safety and immunogenicity endpoints in an ongoing phase 1 HIV vaccine trial (HIV CORE 006)? HIV CORE 006, is a phase 1 HIV vaccine trial that aims to assess the safety, tolerability and immunogenicity of an HIV vaccine candidate called HIVconsvX. The trial is ongoing at a time when different countries are at different stages of waves of the COVID-19 pandemic. It is reasonable to assume that prevailing diseases in the regions are likely to impact assessment of the safety and immunogenicity of HIVconsvx. This impact maybe exacerbated by the spreading SARS-CoV-2 infections. HIV CORE 006 is enrolling 88 individuals (72 vaccine arm: 16 Placebo arm) and this uneven allocation may complicate safety and immunogenicity assessment by acute SARS-CoV-2 infections. In the absence of RT-PCR testing for SARS-CoV-2, this study will attempt to determine the impact of COVID-19 on safety and immunogenicity of HIVconsvx by conducting serology test for SARS-CoV-2 on plasma samples collected from participants prior to vaccination and around the time of vaccination in HIV CORE 006. The data derived from this project will categorise participants based on SARS-CoV-2 infection status and will be used together with primary endpoints of the trial to better understand the trial outcomes. This will be the first time assessment of impact of COVID-19 on primary endpoints in an HIV vaccine trial. The assessment will enable the interpretation of primary endpoints by taking the prevailing COVID-19 pandemic into account.

SANTHE is an Africa Health Research Institute (AHRI) flagship programme funded by the Science for Africa Foundation through the DELTAS Africa programme; the Bill & Melinda Gates Foundation; Gilead Sciences Inc.; and the Ragon Institute of Mass General, MIT, and Harvard.