• Studying the safety, immunogenicity and efficacy of MTBVAC in the most populated country in the world and the one with the highest number of cases of this infectious disease is key to continue advancing in this vaccine.

• Bharat Biotech International Limited in collaboration with Biofabri have started a series of clinical trials to evaluate the safety, immunogenicity and efficacy of MTBVAC in India.

• MTBVAC is being developed for two purposes: as a more effective and potentially longer-lasting vaccine than BCG for newborns, and for the prevention of TB disease in adults and adolescents, for whom there is currently no effective vaccine.

Spain. 24 March 2024. MTBVAC, the Spanish tuberculosis vaccine, the first live attenuated vaccine of Mycobacterium tuberculosis isolated from a human, reaches a new milestone by starting clinical trials in India, the most populated country in the world and the one with the highest number of cases of this infectious disease. 

• TB kills 1.3 million people a year and sickens more than 10 million people annually.
• A new TB vaccine is needed to reach the global End TB goals.
• MTBVAC is a highly promising vaccine candidate that has the potential to be used as an alternative to BCG vaccination in infants and for prevention of TB disease in adolescents and adults.
• Grant from the Bill & Melinda Gates Foundation to IAVI will support efficacy trial.

NEW YORK, U.S. and PORRIÑO, SPAIN — December 18, 2023 — IAVI, a global nonprofit scientific research organization, and Spanish biopharmaceutical company Biofabri, a subsidiary of Zendal, today announced that the Bill & Melinda Gates Foundation has awarded IAVI US$55 million to conduct a Phase IIb trial assessing the safety and efficacy of the tuberculosis (TB) vaccine candidate MTBVAC to prevent active TB lung disease in adolescents and adults. This funding has been made possible in part through a grant provided by Open Philanthropy, a grant-making organization that aims to use its resources to help others as much as it can. This trial is also supported by additional funding provided by the German Federal Ministry of Education and Research (BMBF) through the KfW Development Bank, which provides funding to IAVI and partners in support of developing MTBVAC. It is anticipated that the trial will begin enrolling participants in mid-2024.

The clinical trial will be conducted by South African Tuberculosis Vaccine Initiative (SATVI).
Biofabri, biotechnology company focusing on human health vaccines, will sponsor the Phase 1B clinical trial.