SA part of landmark study to evaluate Covid-19 vaccine efficacy in HIV patients
A landmark clinical trial in eight sub-Saharan African countries will be the first to specifically evaluate the efficacy of a Covid-19 vaccine in people living with HIV.
It also is the first study to evaluate the efficacy of vaccines — in this case, Moderna mRNA-1273 — against the Omicron variant, said the SA Medical Research Council (SAMRC).
The Ubuntu trial is being sponsored by the SAMRC and funded by the US government and supported by the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health.
In addition to examining the efficacy of Covid-19 vaccines in people living with HIV, the study investigators seek to identify the optimal regimen for this population and how it might vary based on whether an individual has previously had Covid-19.
The trial will be conducted in east and Southern Africa, both regions that have been highly affected by HIV.
It is expected to enrol about 14,000 volunteers at 54 clinical research sites in SA, 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.
“The Ubuntu trial will provide safety data to regulators and assess correlates of protection from Covid-19, and 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 enrol about 12,600 people living with HIV and about 1,400 who are HIV-negative.
Around 5,000 of the volunteers will have previously had Covid-19, confirmed by an antibody blood test done at enrolment.
All participants will receive the Moderna vaccine, but dosages and schedules will vary depending on previous SARS-CoV-2 infection.
Although safe and effective vaccines have been developed for Covid-19, HIV and Covid-19 are on a collision course.Dr Glenda Gray, SAMRC head and Ubuntu study protocol lead adviser
Organisers 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 SAMRC head.
“Although safe and effective vaccines have been developed for Covid-19, HIV and Covid-19 are on a collision course.
“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 SA’s fourth wave and further infections globally,” said Gray.
Dr Larry Corey, principal investigator of the HIV Vaccine Trials Network and the Covid-19 Prevention Network, said vaccination and treatment are critical for those who face the dual threat of HIV and Covid-19 “as they remain at high risk of acquisition and transmission and potentially can be the origin of future variants”.
“It is imperative that we as scientists and as society double-down on global efforts to find and make available effective vaccines and treatments. This study represents an important step forward in our efforts to reduce the burden of Covid-19 among HIV-infected persons and understand whether current dosage regimens are adequate.”