The Kenya Medical Research Institute (KEMRI) has commenced a phase 3 clinical trial to evaluate the efficacy of the M72/AS01E tuberculosis (TB) vaccine.
The global trial, funded by the Gates Foundation and Wellcome Trust, aims to combat Pulmonary TB, the most common and deadly form of the disease.
Speaking at KEMRI’s Mtwapa Research Facility in Kilifi on Thursday, KEMRI Director General Elijah Songok revealed that Kenya is the second country, after South Africa, to join this trial.
The study involves 20,000 participants, mainly adults and adolescents, across multiple countries.
“Nairobi and Siaya are among the nine locations in Kenya where the trial will take place,” Songok said, adding that the vaccine’s safety and efficacy will be compared to a placebo.
Kenya’s participation in this international trial highlights the country’s key role in global TB research, contributing to the multi-national study also taking place in South Africa, Zambia, Malawi, Mozambique, Indonesia, and Vietnam.
According to the World Health Organization, TB remains a leading cause of death globally, with 10.6 million cases and 1.3 million deaths reported in 2022.
In Kenya, around 128,000 new TB cases are recorded annually, emphasizing the need for more effective vaccines, particularly for adolescents and adults, as the current BCG vaccine offers limited protection.
Videlis Nduba was named the National Principal Investigator for the study in Kenya, with Caroline Ndila appointed as Sub Investigator and trial site manager for the KEMRI Mtwapa Research Site.
If successful, the M72/AS01E vaccine, in development since the early 2000s, could become the first new TB vaccine in over 100 years.
