CommuniTB Trial (Gates MRI TBV02-301 study)

 

Globally, tuberculosis (TB) is the leading cause of death from a single infectious agent. According to the World Health Organization (WHO), 10.8 million people fell ill with, and 1.25 million people died from TB including 161 000 people living with HIV(PLHIV) in 2023.

The CommuniTB Trial is a Phase 3 multi-centre clinical trial assessing the efficacy, safety and immunogenicity of the investigational M73/AS01E-4 Mycobacterium tuberculosis (Mtb) candidate vaccine in adolescents an adults. The study is sponsored by the Bill and Melinda Gates Medical Research Institute (MRI) with funding support from the Bill and Melinda Gates Foundation and Wellcome. The trial was launched in South Africa in March 2024 by Gates MRI. The trial aims of recruit 20,000 participants across 54 sites in 5 countries: Indonesia, Kenya, Malawi, South Africa, and Zambia. Participants will receive either the investigational M72/AS01E vaccine or a placebo in what is known as a double-blind trial, meaning neither the trial participant nor the clinical investigators will know who receives vaccine or placebo. This approach considered the gold standard for evaluating the safety and efficacy of an investigational vaccine. Zambart is pleased to be one of the 4 sites in Zambia, in the clinical development process of a much-need TB vaccine. Zambart was also a trial site for the Phase IIb clinical trial of same Mtb candidate vaccine in a study sponsored by GSK, Aeras, International Aids Vaccine Initiative (IAVI), and the Gates Foundation from 2015-2018. The CommuniTB trial is being carried out by Zambart in the Kanyama community, with its the clinical research site at Kanyama General Hospital. Our site was activated in September 2024 and the study will run for approximately 4 and a half years. If found to be effective this vaccine could potentially offer hope as a preventative measure against pulmonary tuberculosis. The study is funded by the Bill & Melinda Gates Medical Research Institute (Gates MRI)