From January 2022 to March 2024, the Centre for Infectious Diseases Research in Zambia (CIDRZ), Matero Clinical Research Site (CRS), conducted the CoVPN 3008 (Ubuntu) Multi-Centre, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern.

The study evaluated the safety and effectiveness of the Moderna COVID-19 mRNA vaccine in seven African countries. Participants in the study included adults living with HIV as well as adults with other conditions such as obesity or diabetes, which may also increase the risk of severe COVID-19.

The study assessed how well the COVID-19 mRNA vaccine by Moderna, Inc. helped to prevent COVID-19 illness, including severe illness, among participants.

The CoVPN 3008 (Ubuntu) study is one of the largest prospective studies of a COVID-19 vaccine conducted exclusively in Africa, and the only such trial to enrol a large and diverse population of PLWH, including pregnant persons and individuals with poorly controlled HIV.

The study found that overall hybrid immunity was associated with a significant reduction in the risk of COVID-19 and severe COVID-19 compared to vaccine immunity, but this effect did not seem to hold among PLWH with low CD4 counts or HIV viraemia.

The vaccines also appeared safe and well tolerated in PLWH. Severe COVID-19 was rare in Ubuntu, and most infections were mild or asymptomatic. Importantly, the study identified a subpopulation of participants with persistent SARS-CoV-2 shedding, more often observed among PLWH with a detectable HIV viral load or low CD4 count.

Details of the trial can be found at: https://doi.org/10.1016/j.eclinm.2024.103054.