A funding boost will help advance a pulmonary tuberculosis (TB) vaccine to Phase III clinical trials, which, if approved, could be the first in more than 100 years.

Wellcome and the Bill & Melinda Gates Foundation have announced they will provide funding to GSK to advance a tuberculosis (TB) vaccine candidate, M72/AS01E (M72), through a Phase III clinical trial. If proven effective, M72 (NCT04556981) could become the first new vaccine to help prevent pulmonary TB, a form of active TB, in more than 100 years after Bacillus Calmette-Guerin (BCG).

BCG is the live attenuated vaccine form of Myobacterium bovis used to prevent tuberculosis and other mycobacterial infections. The vaccine was developed by Calmette and Guerin and was first administered to humans in 1921. It helps protect babies and young children but offers limited protection against pulmonary TB among adolescents and adults.

M72 is not the only vaccine candidate in the pipeline

M72 is one of 17 TB vaccine candidates currently in the pipeline and has been in development since the early 2000s. It was developed by GSK up to Phase IIb in partnership with Aeras and the International AIDS Vaccine Initiative (IAVI) with part funding from the Gates Foundation.

In the Phase IIb trial, M72 showed approximately 50% efficacy in reducing pulmonary TB in adults with latent TB infection.

Conducted in collaboration with an international consortium of TB clinical investigators, the Phase III trial will enrol approximately 26,000 people, including people living with HIV without TB infection, at more than 50 trial sites in Africa and South East Asia.

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To support the M72 Phase III clinical trial, which will cost an estimated $550m, Wellcome is providing up to $150m. The Gates Foundation will fund the remainder with $400m.

Tuberculosis killed more than 1.6m people in 2021

In 2021, an estimated 10.6 million people fell ill with TB, with 1.6 million deaths. The disease primarily affects people in low and middle-income countries, and those at highest risk often live in poverty, with poor living and working conditions and undernutrition.

Bill & Melinda Gates Foundation co-chair Bill Gates said: “With TB cases and deaths on the rise, the need for new tools has never been more urgent.

“Greater investment in safe and effective TB vaccines alongside a suite of new diagnostics and treatments could transform TB care for millions of people, saving lives and lowering the burden of this devastating and costly disease.”