Landmark trial testing COVID-19 vaccine efficacy in HIV patients

SA will take part in a ground-breaking clinical trial to evaluate efficacy of a COVID-19 vaccine.

The first clinical trial to exclusively investigate the efficacy of a COVID-19 vaccine in people living with HIV, including those with poorly managed infections, is underway in eight Sub-Saharan African countries. It's also the first study to test the efficacy of vaccines in this case, Moderna mRNA-1273 against the omicron variant of SARS-CoV-2. The Ubuntu trial is being sponsored by SAMRC and funded by the US government and supported by the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health. The trial will take place in East and Southern Africa, two regions of the world where HIV has had a significant impact. Around 14,000 volunteers are planned to be enrolled at 54 clinical trial sites, where adult HIV prevalence ranges from 4.5 % to 27 %.

“Sub-Saharan Africa has been hit hard by the COVID-19 pandemic, but access to effective vaccines, especially mRNA technology, has been very limited,” said Dr. Nigel Garrett, co-chair of the study and head of Vaccine and HIV Pathogenesis Research at the Center for the AIDS Program of Research in South Africa (CAPRISA). “The Ubuntu trial will provide safety data to regulators and assess correlates of protection from COVID-19, and it will answer important questions on mRNA vaccine dosage regimens among people living with HIV.” The study is anticipated to enroll roughly 12,600 HIV-positive adults and about 1,400 HIV-negative people to obtain these and other answers. About 5,000 of the volunteers will have had COVID-19 before, as determined by an antibody blood test performed at the time of initial enrolment.