•The study is funded by the Coalition for Epidemic Preparedness Innovations (CEPI) for up to Sh1.4 billion (US$12.5 million).
•In Kenya, it is being conducted by a Kisumu-based NGO called the Victoria Biomedical Research Institute (VIBRI).
Hundreds of adults in Kenya have been enrolled in a study to evaluate the safety of Covid-19 vaccines in adults living with HIV.
The adults, aged 12 to 64 years, will be given different types of vaccines in a mix-and-match style.
Participants who receive either Moderna or Pfizer MRNA vaccines, or the vaccines produced by Janssen, Sinovac or Sinopharm will receive a booster of either the Janssen or Novavax vaccines five to seven months after completion of the primary vaccination series.
Each study participant will be followed up over an 18-month period. After booster vaccination, investigators will assess the safety and immune response at months six, 12 and 18.
The programme is also ongoing in the Democratic Republic of Congo, and Rwanda.
The study is funded by the Coalition for Epidemic Preparedness Innovations (CEPI) for up to Sh1.4 billion (US$12.5 million).
In Kenya, it is being conducted by a Kisumu-based NGO called the Victoria Biomedical Research Institute (VIBRI).
Dr Lucas Tina, the principal investigator and head of VIBRI, said:
“Despite the rapid successes in Covid-19 vaccine development, it is critical to address the existing scientific data gaps on safety, immunogenicity, and efficacy of Covid-19 vaccines in populations such as children and immunocompromised individuals including People Living with HIV/Aids who have been shown to be at higher risk of severe Covid-19.”
The researchers said data on the effectiveness of Covid-19 vaccines in people living with HIV are limited and many outstanding questions remain.
For instance, it is not clear if people living with HIV are a risk population for SARS-CoV-2 infection and if they have reduced immune responses to Covid-19 vaccination.
It is also not clear if this population can be offered mix and match vaccine regimens to boost their immune responses.
The researchers said insights gained from this study will help Covax (the WHO-led vaccine distribution platform), vaccine providers, and governments to optimise their vaccination schedules so that they can maximise protection against Covid-19 for people living with HIV.
This study is funded in response to a CEPI Call for Proposals launched in January 2021 to address current gaps in clinical knowledge of vaccine performance.
Examples of such gaps include assessment of the safety and effectiveness of Covid-19 vaccines in pregnant women, infants and children, and immunocompromised populations, as well as studies on booster doses, length of vaccine efficacy, mix-and-match strategies, and dosing intervals.
Dr Melanie Saville, executive director of vaccine research and development at CEPI, said:
“This study will help to gather the data needed to fill this gap in our understanding and inform how governments and Covax can optimise their vaccination strategies going forwards to better protect this large vulnerable population of people who are potentially immunocompromised.”