Bharat Biotech's TB vaccine MTBVAC begins clinical trials in India

The clinical trials of the novel tuberculosis vaccine MTBVAC began in India on Sunday, marking a “giant step” forward in the fight against one of the world’s deadliest infectious diseases that kills over 1.6 million people annually.

Developed by Biofabri in collaboration with the Hyderabad-based Bharat Biotech, MTBVAC is derived from a human strain of the Mycobacterium tuberculosis bacteria. It holds promise as a more effective and long-lasting alternative to the BCG vaccine, the only tuberculosis (TB) vaccine currently available.

These clinical trials aim to assess the safety, immunogenicity, and efficacy of MTBVAC. TB claims over 1.6 million lives annually and infects more than 10 million worldwide each year. India, with the world's highest TB burden, is a crucial testing ground for MTBVAC.

The trials will assess the vaccine's safety, immune response, and efficacy in preventing TB in adults and adolescents. MTBVAC has been developed after over three decades of research. The vaccine entered Phase 3 clinical trials in newborns in 2023, comparing its efficacy with the traditional BCG vaccine.

Simultaneously, trials in HIV-uninfected and HIV-infected adults have been initiated to assess safety and immunogenicity, with plans for further efficacy studies in adolescents and adults in Sub-Saharan Africa.

“After more than three decades of research, it is a giant step to test in adults and adolescents in the country where 28 per cent of the world’s TB cases accumulate and concludes that more effort and funding is needed to combat TB, which remains one of the world’s leading infectious causes of death, especially in India,” said Esteban Rodriguez, CEO of Biofabri.

Krishna Ella, Executive Chairman Bharat Biotech stated, “Our quest for a more effective vaccine against Tuberculosis received a big boost today, with clinical trials in India. Our goal to develop TB vaccines to prevent disease in adults and adolescents has taken a big step today. We are honoured to partner with BioFabri.”

MTBVAC's development is a global public-private partnership. The European Union, American institutions like the International AIDS Vaccine Initiative (IAVI), and the National Institutes of Health have all played a role in funding and conducting various stages of the trials.