The Bill & Melinda Gates Medical Research Institute (Gates MRI) has launched its Phase 3 clinical trial to assess the efficacy of the M72/AS01E tuberculosis (TB) vaccine. The first doses of the vaccine will be given in South Africa, where the disease is more prevalent.

At full capacity, the trial will include up to 20,000 participants, including people living with HIV, at up to 60 trial sites in seven countries. These are South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam.

If proven to be well-tolerated and effective, M72/AS01E could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults. This will also be the first new TB vaccine in over a century.

Reports from the World Health Organization indicate that an estimated 10.6 million people contracted TB in 2022 and 1.3 million died within the same year. The disease primarily affects people in low- and middle-income countries. In South Africa alone, about 280,000 people are diagnosed with TB each year.

Speaking at the launch of Phase 3 of clinical trials, Emilio A. Emini, Ph.D., CEO of the Gates MRI noted, “The launch of this pivotal Phase 3 trial demonstrates our commitment to harnessing the power of medical innovation to fight diseases like TB that are particularly devastating for low- and middle-income countries. Clinical study of the vaccine will still require years, but our incredible partners in South Africa and elsewhere who have come together for the Phase 3 study share our hope in the vaccine’s potential.”

Participants will receive either the investigational M72/AS01E vaccine or a placebo in what is known as a double-blind trial. This means that neither the trial participant nor the clinical investigators will know who receives vaccine or placebo. This approach is considered the gold standard for evaluating the safety and efficacy of an investigational vaccine.

It is anticipated that the trial will take up to five years to be completed. This will be followed by data analysis and then preparation for submission of data to regulatory authorities.