A randomised, controlled clinical trial to assess and compare the immunogenicity, safety and reactogenicity of the bivalent Omicron BA.4/BA.5 adapted, and the original Wuhan-Hu-1-strain, BNT162b2 COVID-19 Vaccine formulations in healthy unvaccinated East African adults

The project title is “A randomized, controlled clinical trial to assess and compare the immunogenicity, safety and reactogenicity of a bivalent Omicron BA.4/BA.5 adapted, and the original Wuhan-Hu-1-strain, BNT162b2 COVID-19 vaccine formulations in healthy unvaccinated East African Adults." but will be simply be known as "BiMVaC01"

The aim of the project is to assess and compare the Bivalent Omicron Virus and the Original Wuhan Virus. The study will involve clinical trials to assess and compare the bivalent and monovalent vaccines.

A monovalent vaccine was administered in the early stages of the virus provided immunity against the Wuhan virus, the original COVID-A9 virus from China, however, due to the virus’s adaptation changes the vaccine is no longer sufficient. This created a need for a new vaccine, the bivalent vaccine, that would accommodate all the changes of the virus.

A total of 580 participants from Tanzania and Kenya will be recruited to take part in the study. They will be followed up for 6 months with samples from the participants in both countries being exchanged between a laboratory in Tanzania and another laboratory in Kenya. 

In Tanzania, the trial will be conducted in three sites within Dar es Salaam region - Mwananyamala, Amana and Temeke. 

The duration of the study will be from December 2022 to September 2024. Already, some of the activities planned for the study have already started to take place, to ensure smooth operations once the trials begin. 

Ifakara Health Institute will implement the study in collaboration with Kenya Wellcome Trust with funding and support from The University of Oxford.