Human Rights Day: The right to education remains elusive. Why is…Vivaldi Day: it’s all about youCambridge, Mass, USA, March 19, 2024 -/African Media Agency /- The Bill & Melinda Gates Medical Research Institute today announced that a Phase 3 clinical trial to assess the efficacy of the M72/AS01E tuberculosis vaccine candidate is now underway, with first doses given in South Africa, where TB takes a heavy toll.
Making vaccines accessible and affordable for communities in areas of high disease burden in the long-term is a priority for all trial partners. The Gates MRI has worked with a wide range of stakeholders, including communities around clinical trial sites, to guide the TB candidate vaccine to Phase 3.
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 — South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam. 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.
“If effective, M72/AS01E could reinvigorate a global fight against TB that has been weakened by the COVID-19 pandemic,” said Alemnew Dagnew, M.D., who leads development of M72/AS01E at the Gates MRI. “I am particularly excited to see this trial get underway because when I was working as a physician in Ethiopia, I saw first-hand what pulmonary TB does to communities — and a vaccine that could help prevent that from happening would be transformative.