NAIROBI, Kenya, October 4 – A phase 3 clinical trial has been initiated by the Kenya Medical Research Institute (KEMRI) to evaluate the efficacy level of the M72/ASO1E tuberculosis (TB) vaccine.
Speaking at the KEMRI Mtwapa Research Facility in Kilifi on Thursday, KEMRI Director General, Elijah Songok said that the global trial is funded by the Gates Foundation and Wellcome Trust and targets to combat Pulmonary TB which is considered AS the most common AND deadly form of the TB.
According to the DG, Kenya is the second country after South Africa to join the global trial, which involves 20,000 participants, particularly adults and adolescents.
According to the DG, Nairobi and Siaya will be among the nine locations where the trial will be undertaken.
The trial will compare the vaccine to a placebo, which will help assess the vaccine’s safety and efficacy level.
“Kenya’s involvement is a critical component of the multi-national trial spanning South Africa, Zambia, Malawi, Mozambique, Indonesia, and Vietnam,” he added.
“KEMRI’s participation in this international collaboration, funded by the Gates Foundation and Wellcome, underscores Kenya’s pivotal role in global TB research and its commitment to public health solutions,” he stated.
According to the World Health Organization, TB remains one of the leading causes of death globally, with 10.6 million cases and 1.3 million deaths recorded in 2022 alone.
In Kenya, approximately 128,000 new TB cases are reported each year, underscoring the urgent need for new and effective vaccines, especially for adolescents and adults, where the current vaccine, BCG, offers limited protection.
Videlis Nduba was announced as the National Principal Investigator of the study in Kenya, while Caroline Ndila was named as the Sub Investigator and trial site manager of the KEMRI Mtwapa Research Site.
If successful, M72/AS01E, which has been in development since the early 2000s, could be the first new TB vaccine in over a century.
