The Bill & Melinda Gates Medical Research Institute announced today the launch of a Phase 3 clinical trial of its tuberculosis (TB) vaccine candidate, M72/AS01E (M72), with the first vaccinations taking place in South Africa.
If proven safe and effective, the M72 candidate vaccine could become the first to prevent the most common form of TB disease in adolescents and adults, and would be the first new TB vaccine in over a century, the statement said.
The trial, if fully enrolled, will involve up to 20,000 participants, including people living with HIV but not TB, across 60 trial sites in seven countries: South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia, and Vietnam. Participants will be randomized to receive either the M72/AS01E vaccine or a placebo in a double-blind trial, meaning that neither the trial participants nor the clinical researchers know whether the participant is receiving the vaccine or the placebo. This approach is considered the gold standard for evaluating vaccine safety and effectiveness.
TB is one of the world's deadliest infectious diseases and is also a leading cause of death for people living with HIV. The BCG vaccine is the only TB vaccine currently in use, and it was first introduced in 1921. It protects young children from severe, systemic forms of TB, but is not very effective at preventing pulmonary TB in adolescents and adults, who are the main drivers of TB transmission.
According to the World Health Organization, there were an estimated 10.6 million new TB cases and 1.3 million TB deaths globally in 2022. This means that over 3,500 people die from TB every day. TB disproportionately affects people in low- and middle-income countries, with people living in poverty with poor living and working conditions and malnutrition facing the highest risk of developing TB. South Africa alone accounts for approximately 280,000 new TB diagnoses each year.
The Gates Medical Research Institute is a non-profit organization and an affiliate of the Bill & Melinda Gates Foundation. The trial is funded by a partnership of the Gates Foundation and the Wellcome Trust. The trial is expected to take five years to complete, after which data will be analyzed and submitted to regulatory authorities.
