Trials Undertaken | Center for Family Health Research in Zambia (CFHRZ)

Clinical Trial

CoVPN 3008: UBUNTU Study


Trial Description
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.,undefined

Purpose of Trial
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

Eligibility Criteria
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.

What You Need to Know
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.

Sponsored By:

Covid-19 Prevention Network

Principal Investigator:

William Kilembe, Mubiana Inambao

Posted:

23/11/2023 | 1 year ago