CoVPN 3008: UBUNTU Study
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 will be referred to as the COVID-19 mRNA vaccine. The study hopes to enroll up to 15,600 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 COVID-19 vaccine being used in the UBUNTU study?
The vaccine has received full approval in the United States, where over 200 million doses have been administered to people. In addition, over 150 million doses have been given to people in Europe under a Conditional Marketing Authorization. This vaccine is also recommended by the World Health Organization. Hundreds of millions of doses of this vaccine have been given and it has been shown to be over 90% effective in preventing COVID-19 illness caused by the strains seen early in the pandemic. And to date there have been no significant safety concerns associated with this vaccine.
Where will this study be done?
| Country | City |
| Botswana | Gaborone |
| Eswatini | Mbabane |
| Kenya | Eldoret Moi University Clinical Research Centre Kisumu |
| Malawi | Blantyre Lilongwe |
| South Africa |
Bloemfontein |
| Uganda | Entebbe Kampala (3 clinics) |
| Zambia | Lusaka (3 clinics) |
| Zimbabwe | Harare (7 clinics) |
Why is This Study Being Done?
The UBUNTU study is a research study evaluating the 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 or other 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 reinfection. 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.
How many people will be in this study and who can join?
The study hopes to enroll about 15,600 people from Eastern and Southern Africa. The study will enroll adults who are living with HIV or have another condition that has 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.
Is the UBUNTU study vaccine safe?
Over 350 million doses of the COVID-19 mRNA vaccine have been used to vaccinate people. Most people have mild to moderate reactions after receiving the vaccine, particularly after a second dose. These reactions usually happen 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 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.
Can the UBUNTU study vaccine protect participants from getting infected with the SARS-CoV-2 virus?
While the 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 there.
Is the UBUNTU study the same as the National COVID-19 vaccine rollout?
The UBUNTU study is not the same as the national COVID-19 vaccine rollout, it is a research study to evaluate the 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.
How will the health and rights of participants be protected?
Protecting the health and respecting the rights of participants are top priorities for everyone in the CoVPN. Without volunteer participants, we would never have been able to develop any of the COVID-19 vaccines.
A first step in protecting the rights of study participants is to give them information about the study before they join. Clinic staff will give people information about the study product and procedures, the possible risks and benefits to participants, and the rights that they have. These include the right to receive any new information about the study that could affect whether they want to stay in it, and the right to leave the study at any time.
During the study, the clinic staff will carefully monitor participants to make sure the study vaccine is not causing any health problems.
There are several groups involved in protecting participants’ rights and well-being:
- A study Protocol Safety Review Team (PSRT) and an independent Data Safety Monitoring Board (DSMB) regularly look at the health information from the study to decide whether it appears safe to continue giving vaccinations as planned.
- An Institutional Review Board (IRB) or Research Ethics Committee (REC) reviews and monitors the study plan for each clinic doing the study, including the information that is given to people about the study, study progress, and health problems in participants. The IRB/REC also looks at whether participant rights are being respected.
- The South Africa Health Products Regulatory Authority (SAHPRA), as well as national regulatory authorities of other countries, oversee the conduct of the study and require regular reports on the safety of participants.
- Because funding for the study is provided by the US National Institutes of Health, the study follows all the international and US laws that govern research in humans and the use of vaccines in research.
- Some clinics have a special REC that oversees the place where blood and other samples are stored. These places are called bio-banks or repositories.
- Each study clinic has a Community Advisory Board (CAB). Its members are local people who bring the concerns and interests of the community and study participants to the researchers. CAB members are part of the team that developed this study. They also help develop or review the information that is given to participants.
Where can I find more information?
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/faq.html
About CoVPN's Mission | COVID-19 Prevention Network (www.coronaviruspreventionnetwork.org)
South Africa COVID-19 Prevention Network - Coronavirus Clinical Studies (preventcovid.org.za)
Content last reviewed on May 25, 2022