The Bill & Melinda Gates Medical Research Institute (Gates MRI) has announced the initiation of a phase 3 clinical trial to evaluate the efficacy of a new vaccine candidate to protect adolescents and adults from pulmonary tuberculosis (TB).
If effective, the M72/AS01E vaccine could be the first available to help prevent pulmonary TB and the first new TB vaccine in over a century.
Estimated to affect 10.6 million people globally in 2022, according to the World Health Organization (WHO), TB is an infectious disease caused by the bacterium Mycobacterium TB, which often affects the lungs and sometimes other organs, otherwise known as pulmonary TB.
Being dosed for the first time in South Africa, the large pivotal trial for M72/AS01E is being sponsored by the Gates MRI, supported by funding from the Gates Foundation and Wellcome.
Over the next five years, the trial will recruit up to 20,000 participants, including individuals living with HIV, at up to 60 trial sites in seven countries: South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam, to receive either investigational M72/AS01E or a placebo.
First developed in the early 2000s, M72/AS01E was originally designed and clinically evaluated by GSK up to the proof-of-concept phase and was licensed to the Gates Foundation in 2020, prior to partnering with the Gates MRI in 2022 for further development.
Phase 2b trial results showed that M72/AS01E provided 50% protection against progression to active pulmonary TB for three years in Mycobacterium TB-infected HIV-negative adults.
Together, the Gates MRI, GSK and Wellcome, along with the Gates Foundation, will continue to work to build an end-to-end plan to ensure long-term sustainable access to M72/AS01E, such as by supporting research and building an evidence base.
GSK will supply the adjuvant component – an ingredient that creates a stronger immune response in vaccines – of the vaccine for the phase 3 trial and, if successful, will provide the adjuvant post-licensure.
Trevor Mundel, president, global health, the Gates Foundation, commented: “This trial marks the beginning of a series of opportunities that will usher in the most promising pipeline ever of new TB tools.”