CAPRISA enrols first participant into the CoVPN 3008 ‘Ubuntu’ trial for people living with HIV
On 2 Dec 2021, CAPRISA enrolled the first participant into the Ubuntu trial which evaluates the efficacy of the Moderna mRNA-1273 vaccine in people living with HIV. “The Ubuntu study will provide safety data to regulators, assess correlates of protection from COVID- 19 and it will answer important questions on mRNA vaccine dosage regimens among people living with HIV,” explained Dr Nigel Garrett, co-Chair of the study and Head of Vaccine and HIV Pathogenesis Research at CAPRISA. It is also the first study to evaluate the efficacy of Moderna mRNA-1273 against the Omicron variant.
The trial is being conducted in Eastern and Southern African regions and is expected to enroll about 14,000 volunteers at 54 clinical research sites in South Africa, Botswana, Zimbabwe, Eswatini, Ma- Malawi, Zambia, Uganda, and Kenya, where adult HIV prevalence ranges from 4.5% to 27%. The study aims to enroll 12,600 people living with HIV and 1,400 who are HIV-negative. About 5,000 of the volunteers will have previously had COVID- 19, with confirmation based on blood antibody tests done at initial enrollment. Study participants living with HIV will receive optimal HIV treatment through the course of the trial.
All participants will receive the Moderna vaccine, but dosages and schedules will vary depending on previous SARS-CoV-2 infection. Those with past infection will receive fewer doses of vaccine, based on evidence that prior immunity may be markedly enhanced by vaccination.
In the photo:(L): Dr Nivashnee Naicker Research Clinician & Dr Nigel Garrett at the CAPRISA eThekwini Research Clinic.