A clinical trial of 8 sub-Saharan African countries will be the first to study the efficacy of mRNA COVID-19 vaccination in people living with HIV.
An impending study will be the first to evaluate efficacy of mRNA COVID-19 vaccination in people living with HIV, including those struggling to maintain viral suppression. The Ubuntu study will also be the first to analyze the efficacy of mRNA vaccines against the Omicron variant.
The Ubuntu study is named after a Nguni word meaning “I am because you are.” It refers to the community interconnectedness of African nations as they collaborate to defeat COVID-19 and HIV.
The trial will take place in East and Southern Africa, regions that are disproportionately affected by both HIV and COVID-19. The Ubuntu study will consist of 54 clinical research sites in South Africa, Botswana, Zimbabwe, Eswatini, Malawi, Zambia, Uganda, and Kenya, countries where adult HIV prevalence ranges from 4.5%-27%.
The study anticipates enrolling 12600 people living with HIV and 1400 HIV-negative people. Approximately 5000 of all participants will have contracted and recovered from COVID-19. All participants will receive the Moderna mRNA vaccine.
The Ubuntu study is made possible with “critical participation” from rural residents from communities across East and Southern Africa. Dr. Philip Kotzé, one of the study’s lead investigators, said, “These communities have been disproportionately impacted by the twin pandemics of HIV and COVID-19, and they now have an unprecedented opportunity to help advance science and improve our understanding of the immune response to SARS-CoV-2 in the context of HIV.”
In addition to receiving COVID-19 vaccination, the Ubuntu participants living with HIV will receive “optimal” HIV treatment throughout the study, organizers said.
The Ubuntu study is sponsored by the South African Medical Research Council (SAMRC) and funded by the US government. It receives additional support from the National Institute of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID).
The study is led by the NIH’s COVID-19 Prevention Network (CoVPN), and was modeled on successfully community engagement protocols implemented by CoVPN and the HIV Vaccine Trials Network (HVTN).