The Bill & Melinda Gates Foundation and Wellcome have joined forces to fund the late-stage development of what could be the first tuberculosis (TB) vaccine in over a century.

TB is a bacterial infection spread by inhaling tiny droplets from the coughs or sneezes of an infected person.

Despite being both curable and preventable, the disease continues to affect around ten million people every year, and 1.6 million people died from it in 2021, almost entirely in low and middle-income countries.

The only TB vaccine in use today, bacille Calmette-Guérin (BCG), was first used in 1921. It helps protect babies and young children against severe systemic forms of TB, but offers limited protection against pulmonary TB – a form of active TB – among adolescents and adults.

The Gates Foundation and Wellcome will invest around $550m to support the phase 3 trial of the M72/AS01E (M72) vaccine, which will be tested to see how well it prevents latent TB from becoming active TB and causing illness.

The study is expected to take four to six years and will enrol 26,000 people, including those living with HIV and without TB infection, at more than 50 sites across Africa and Southeast Asia.

M72 has already been shown in a phase 2b trial to prevent active TB from developing in around half of those who received it.

Julia Gillard, chair of the board of governors at Wellcome, said: “TB remains one of the world’s deadliest infectious diseases.

“The development of an affordable, accessible vaccine for adults and adolescents would be game-changing in turning the tide against TB.

The vaccine has been in development since the early 2000s by GSK in partnership with non-profit Aeras and the International AIDS Vaccine Initiative.

In 2020, the UK-based drugmaker announced that it would partner with the Gates Medical Research Institute for continued development and potential use of M72 in countries with a high TB burden, with GSK continuing to provide the adjuvant for the candidate's further development and potential launch.

Bill Gates, co-chair of the Gates Foundation, said: “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.”

Reference：

https://www.pmlive.com/pharma_news/gates_foundation_and_wellcome_to_fund_late-stage_trial_of_tuberculosis_vaccine_candidate_1493976