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.
What do we currently know about the Moderna COVID-19 vaccine being used in the UBUNTU study?
The Moderna COVID-19 vaccine used in this study is under an Emergency Use Authorization in the United States. This vaccine is also on the Emergency Use Listing by the World Health Organization, which recommends its use to prevent COVID-19 disease. It has been given to more than 70 million people and has been shown to be over 90% effective in preventing COVID-19 illness caused by the strains of the virus in the US and Europe.
Kampala (3 clinics)
|Zambia||Lusaka (3 clinics)|
|Zimbabwe||Harare (7 clinics)|
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.
Over 70 million people have already received the Moderna COVID-19 mRNA vaccine being used in this study. Most people have mild to moderate reactions after receiving the vaccine, particularly after a second dose. These reactions usually happen for one or two days after receiving the vaccine. For most people these reactions do not affect their daily lives and go away within a few days. Common reactions include pain in the arm where the injection was administered, fatigue, headaches, muscle and joint pain, and chills. Occasionally people have redness or swelling where the injection was administered.
An extremely small number of people who receive the Moderna COVID-19 mRNA vaccine develop myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart). The chance of developing this reaction is very, very low. When it happens, it most often occurs in men less than 20 years of age. Symptoms usually do not last long and most people get better. Study participants should tell us right away if they develop chest pain; shortness of breath; or the feeling of a fast-beating, fluttering, or pounding heart after receiving a dose, as they may need medical care.
While the Moderna COVID-19 mRNA vaccine being used in the UBUNTU study may not prevent all SARS-CoV-2 virus infections, studies done in the United States and Europe have found that the vaccine is very effective at preventing severe COVID-19 illness and death. And it has been shown to work well against most strains of SARS-CoV-2 circulating there. However, there is less known about how well the vaccine will protect people in Eastern and Southern Africa.
The UBUNTU study is not the same as the National COVID-19 vaccine rollout. It is a research study to evaluate the Moderna COVID-19 mRNA vaccine. Research is not the same as medical care. The purpose of a research study is to answer a scientific question. If you have access to other COVID-19 vaccines outside of this study through a national rollout, we urge you to carefully consider whether joining this study is right for you. Take your time in deciding. If it helps, talk to people you trust, such as your doctor, friends, or family.
We need your help to keep learning and improving vaccines against COVID-19. We made history with safe and effective vaccines and we’ll keep working as long as there are people to protect, variants emerging, and research answers needed to end this pandemic. To participate:
Content last reviewed on December 16, 2021