Wellcome and the Bill & Melinda Gates Foundation announced Wednesday they will provide a combined $550 million to fund a Phase III clinical trial of the tuberculosis (TB) candidate M72/AS01E (M72). If proven effective in the clinical trial, M72 could become the first new vaccine in more than 100 years to prevent a form of active TB called pulmonary TB. To support the M72 clinical trial Wellcome is providing $150 million with the remaining $400 million to be provided by the Gates Foundation.
Tuberculosis continues to be one of the deadliest diseases worldwide with more than 10 million cases reported in 2021 and 1.6 million deaths, with the major burden of the disease borne by people living in low- and middle-income countries. More than one-quarter of the world’s population is thought to have latent TB—infected with the virus and at risk of progressing to active TB.
“Despite being curable, TB remains one of the leading causes of death in South Africa,” said Nomathamsanqa Majozi, head of public engagement at Africa Health Research Institute. “In the area where I live and work, more than half of all people have had, or will have, TB at some point in their lives. The consequences are devastating, both at a personal and a community level. M72 offers us new hope for a TB-free future.”
Currently, the only vaccine available to fight TB is bacille Calmette Guérin (BCG) which was first administered in 1921. The vaccine provides protection to babies and children but is limited in protecting adolescents and adults against pulmonary TB. M72 is currently one of 17 candidates in the TB vaccine pipeline. In development since the early 2000s, the candidate has been developed through Phase IIb proof-of-concept trials by GlaxoSmithKline (GSK) via a partnership with Aeras and the International AIDS Vaccine Initiative, with funding provided by the Gates Foundation. In the Phase IIb trial, M72 showed roughly 50% efficacy in reducing pulmonary TB in adults with latent TB.
“TB remains one of the world’s deadliest infectious diseases,” said Julia Gillard, chair of the Board of Governors at Wellcome. “The development of an affordable, accessible vaccine for adults and adolescents would be game-changing in turning the tide against TB. By working with communities and researchers in countries with a high burden of the disease, we can get one step closer to eliminating TB as a public health threat.”
The upcoming Phase III trial to assess M72 will be sponsored by the Gates Foundation subsidiary the Bill & Melinda Gates Medical Research Institute (the Gates MRI). The trial expects to enroll around 26,000 people in collaboration with a consortium of TB researchers and will include people living with HIV and those without a TB infection. Participants will be recruited at more than 50 sites in Africa and Southeast Asia. The Gates MRI is the license holder for M72 in low- and middle-income countries with a high burden of the disease.