The Kenya Medical Research Institute (KEMRI) has announced the launch of a Phase 3 clinical trial for the M72/AS01E tuberculosis (TB) vaccine candidate in Kenya.
According to a press statement from the KEMRI, this pivotal study aims to assess the efficacy of the vaccine, which holds promise as a groundbreaking solution to combat pulmonary TB, the most common and deadly form of the disease, particularly in low- and middle-income countries.
The World Health Organization notes that 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 for example, 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.
Following the first dosing of participants in South Africa in March 2024, Kenya became the second country to join the trial in July 2024, with sites across nine locations nationwide.
The National Principal Investigator of this study in Kenya is Dr. Videlis Nduba, while Dr. Carolyne Ndila is the Sub-Investigator and also the Trial Site Manager of the KEMRI Mtwapa Research Site.
Together the Kenyan sites are part of the over 20,000 participants globally, including individuals with other infectious diseases such as HIV. Kenya’s involvement is a critical component of the multi-national trial spanning South Africa, Zambia, Malawi, Mozambique, Indonesia, and Vietnam.
The randomized, double-blind trial will compare the M72/AS01E vaccine candidate to a placebo, providing a rigorous evaluation of the vaccine’s safety and efficacy. If successful, M72/AS01E could be the first new TB vaccine in over a century, offering a new level of protection for adults and adolescents, and helping to significantly reduce TB transmission not just in Kenya, but worldwide.
The M72/AS01E vaccine has been in development since the early 2000s and showed promising results in a Phase 2b trial conducted by GSK. This trial demonstrated that the vaccine offered approximately 50% protection against active pulmonary TB in adults who were infected with the TB bacterium. Should the current trial confirm these results, it is estimated that this vaccine could save up to 8.5 million lives over 25 years, prevent 76 million new TB cases, and reduce the economic burden on TB-affected households by $41.5 billion.
The trial is sponsored by the Bill & Melinda Gates Medical Research Institute (Gates MRI) with funding from the Gates Foundation and Wellcome. KEMRI, in collaboration with international partners including GSK, plays a crucial role in advancing this vaccine towards regulatory approval and potential global distribution. The trial partners are also developing a long-term plan to ensure sustainable access to the vaccine in high-burden regions like Kenya.
KEMRI’s participation in this global initiative highlights Kenya’s leadership in TB research and the country’s commitment to addressing major public health challenges through innovative solutions.