The UBUNTU Study is a randomized efficacy study of a COVID-19 mRNA vaccine in Eastern and Southern Africa. This study is also known as “CoVPN 3008.” The study is being done by the COVID-19 Prevention Network (CoVPN). The study vaccine was developed by the company ModernaTX and is known as the Moderna COVID-19 mRNA vaccine. The study will enroll about 14 000 people at approximately 54 research clinics. Anyone interested in joining the study will go through an informed consent process to learn about it before being asked if they wish to participate.
The Study, named Ubuntu after the Nguni word meaning “I am because you are”, embraces the notion of African co-existence and community, which resonates with the fundamental message to the global response to COVID-19 that “no-one is safe until everyone is safe”.
The UBUNTU study is a research study evaluating the Moderna COVID-19 mRNA vaccine. We already know that this vaccine works in preventing COVID-19 disease including severe COVID-19. It is widely used in the United States and many other countries.
We want to know how many doses of vaccine are needed for protection against COVID-19 for adults living with HIV and adults with existing health conditions that may put them at risk for severe COVID-19. We also want to know if people who have already had COVID-19 (and likely have some immunity) need as many vaccine doses as other people to obtain strong protection from COVID-19. Everyone who joins the study will get the study vaccine. There are 4 groups in this study. The groups differ in the number of doses of study vaccine given. The groups are organized by whether or not people are living with HIV and whether or not people have evidence of prior SARS-CoV-2 infection in their blood.
The study will enroll about 14 000 people from Eastern and Southern Africa. The study will enroll adults who are living with HIV and/or have one or more conditions that have been associated with increased risk of developing severe COVID-19 illness. Examples of such conditions include pregnancy, diabetes, obesity, heart or kidney disease, and cancer.