A highly anticipated clinical trial in eight sub-Saharan countries is the first to specifically evaluate the efficacy of a COVID-19 vaccine in people living with HIV, including those with poorly controlled infections. It also is the first study to evaluate the efficacy of vaccines—in this case, Moderna mRNA-1273—against the omicron variant of SARS-CoV-2, the virus that causes COVID-19.
The trial will be conducted in East and Southern Africa—regions of the world that have been highly impacted by HIV. The study investigators seek to identify the optimal vaccine regimen for this population and how it might vary based on whether an individual has previously had COVID-19. It is expected to enroll about 14,000 volunteers at 54 clinical research sites in South Africa, Botswana, Zimbabwe, Eswatini, Malawi, Zambia, Uganda, and Kenya, where adult HIV prevalence ranges from 4.5% to 27%.
The study name, Ubuntu, borrows the Nguni word meaning “I am because you are,” and embraces the concept of African coexistence and community. It refers to the interconnectedness of African nations and their collaborative efforts to combat HIV and COVID-19 in this region of the continent.
“Sub-Saharan Africa has been hit hard by the COVID-19 pandemic, but access to effective vaccines, especially mRNA technology, has been very limited,” said Dr. Nigel Garrett, co-chair of the study and head of Vaccine and HIV Pathogenesis Research at the Center for the AIDS Program of Research in South Africa. “The Ubuntu trial will provide safety data to regulators and assess correlates of protection from COVID-19, and it will answer important questions on mRNA vaccine dosage regimens among people living with HIV.”
To find these and other answers, the study is expected to enroll about 12,600 people living with HIV and about 1,400 who are HIV-negative. About 5,000 of the volunteers will have previously had COVID-19, confirmed by an antibody blood test done at initial enrollment. All participants will receive the Moderna vaccine, but dosages and schedules will vary depending on previous SARS-CoV-2 infection. Organizers said study participants living with HIV will receive access to optimal HIV treatment throughout the course of the trial.
“This region faces a huge HIV burden,” said Dr. Glenda Gray, Ubuntu study protocol lead adviser and president of the South African Medical Research Council (SAMRC). “Although safe and effective vaccines have been developed for COVID-19, HIV and COVID-19 are on a collision course,” she added. “The impact of COVID-19 on people living with HIV is a concern for the continent, particularly in light of the recently-sequenced omicron variant set to drive South Africa’s fourth wave and further infections globally.”
The trial is sponsored by the SAMRC and funded by the U.S. government and supported by the National Institute of Allergy and Infectious Diseases within the National Institutes of Health. Funding originates from the Department of Health and Human Services through the Countermeasures Acceleration Group.
Edited by Gary Cramer