Cambridge, Mass., USA – In a effort to combat tuberculosis (TB), the Bill & Melinda Gates Medical Research Institute (Gates MRI) has initiated a Phase 3 clinical trial for the M72/AS01E TB vaccine candidate. This trial, first launched in South Africa, marks a significant milestone in the quest for a viable TB vaccine, with potential global implications.
TB remains a formidable global health threat, claiming millions of lives annually, particularly in low- and middle-income countries. With an estimated 10.6 million TB cases reported in 2022 alone, and over 1.3 million deaths, the urgent need for innovative solutions is paramount.
Dr. Emilio A. Emini, CEO of the Gates MRI, underscored the importance of this initiative: “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.”
The M72/AS01E vaccine, if proven effective, could be a game-changer in TB prevention, especially among adolescents and adults, the most vulnerable demographic. With TB being the leading cause of death amongst people living with HIV, the need for an effective vaccine is dire.
Dr. Lee Fairlie, Director of Maternal and Child Health at Wits RHI, University of the Witwatersrand, Johannesburg, South Africa, emphasized the local and global significance of the trial: “Reaching Phase 3 with an urgently needed TB vaccine candidate is an important moment for South Africans because it demonstrates that there is a strong local and global commitment to fight a disease that remains distressingly common in our communities.”
The Phase 3 trial, spanning up to 60 sites in seven countries, including South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia, and Vietnam, aims to enroll up to 20,000 participants. Through a rigorous double-blind approach, participants will receive either the investigational M72/AS01E vaccine or a placebo, ensuring the robust evaluation of safety and efficacy.
Dr. Alemnew Dagnew, leading the development of M72/AS01E at the Gates MRI, highlighted the transformative potential of the vaccine: “If effective, M72/AS01E could reinvigorate a global fight against TB that has been weakened by the COVID-19 pandemic.”
While the trial is anticipated to take up to five years to complete, its potential impact is profound. With the M72/AS01E vaccine showing approximately 50 per cent protection against progression to active pulmonary TB in previous trials, its widespread adoption could save millions of lives and prevent millions of new TB cases globally.
About Gates MRI
The Bill & Melinda Gates Medical Research Institute is a non-profit medical research organization dedicated to the development and effective use of novel biomedical interventions addressing substantial global health concerns, for which investment incentives are limited, including malaria, tuberculosis, enteric and diarrheal diseases, and diseases that impact maternal, newborn, and child health. For further information please visit www.gatesmri.org.