The initial group of Kenyans received what is expected to be the first TB vaccine in nearly a century. The vaccinations were administered on July 12 in Kisumu, Kilifi, Machakos, and Nairobi.
However, the vaccine is still in trial phases and may not be publicly accessible until 2030.
The new TB vaccine is administered through two intramuscular injections given one month apart. Currently, the only available TB vaccine is the BCG, developed in 1921 for children. While BCG protects infants and young children from severe TB forms, it provides inadequate protection for adolescents and adults against the pulmonary TB that primarily spreads the bacterium.
The Kenya Medical Research Institute (KEMRI) is leading the Phase 3 trial for the new adult TB vaccine in Kenya, the final phase before potential adoption. This trial will take place at nine clinical sites.
“Starting the Phase 3 trial for a TB vaccine candidate in Kenya is a significant milestone, and we are excited to be part of the global effort driving this program,” said Dr. Videlis Nduba, Senior Research Scientist at KEMRI and the national principal investigator for the trial in Kenya. “TB continues to affect our communities, and we are dedicated to addressing this public health challenge.”
The vaccine candidate, named M72/AS01E, has been in development since the early 2000s. It was initially designed and clinically tested by GSK up to the proof-of-concept phase (Phase 2b) in collaboration with Aeras and the International AIDS Vaccine Initiative, with funding from GSK and partially from the Bill & Melinda Gates Foundation.
In 2020, GSK formed a partnership with Gates MRI to advance the development of the M72/AS01E vaccine.
KEMRI stated, “The M72 vaccine is designed to prevent TB-infected individuals from progressing to active disease. Early Phase 2 trial results suggest the vaccine is quite promising.”
In GSK’s Phase 2b trial, M72/AS01E offered about 50% protection (13 out of 1626 versus 26 out of 1663) against the development of active pulmonary tuberculosis over a three-year period in HIV-negative adults with TB. This level of protection is a significant breakthrough in TB vaccine research.
According to the World Health Organization, this level of efficacy could potentially save 8.5 million lives, prevent 76 million new TB cases, and save $41.5 billion (Sh5.3 trillion) for TB-affected households over 25 years.
In Kenya, about 128,000 TB cases are reported annually.
The current trial, funded by Gates MRI—a nonprofit affiliated with the Bill & Melinda Gates Foundation and Wellcome Trust—aims to involve up to 20,000 participants, including those with HIV, across 60 sites in Kenya, South Africa, Zambia, Malawi, Mozambique, Indonesia, and Vietnam.
The trial began in South Africa in March, where TB has a severe impact. Completion is anticipated to take at least five years.
Trevor Mundel, President of Global Health at the Bill & Melinda Gates Foundation, remarked, “We must act swiftly to develop and distribute innovative tools to revolutionize TB prevention, diagnosis, and treatment. The launch of the Gates MRI’s M72 TB vaccine candidate Phase 3 trial is a crucial milestone in the global effort to eliminate TB, which continues to devastate the most vulnerable communities.”