Innovative Tuberculosis Vaccine, MTBVAC, Enters Clinical Trials in India

In a major leap forward in the fight against tuberculosis (TB)—a deadly infectious disease claiming over 1.6 million lives annually—the clinical trials for the innovative TB vaccine, MTBVAC, commenced in India this Sunday. This marks a significant milestone in global health, with MTBVAC emerging as a potential game-changer in TB prevention.

Developed through a partnership between Biofabri and Bharat Biotech of Hyderabad, MTBVAC is based on a human strain of Mycobacterium tuberculosis. It stands as a beacon of hope, promising enhanced and lasting protection against TB compared to the century-old BCG vaccine, which currently offers limited efficacy against pulmonary TB, the most common form of the disease.

The clinical trials aim to thoroughly assess the safety, immunogenicity, and effectiveness of MTBVAC in adults and adolescents. With TB affecting more than 10 million individuals worldwide each year, India, shouldering the world's highest TB burden, is a critical venue for these pivotal trials.

Reflecting on decades of rigorous research, MTBVAC has now progressed to Phase 3 clinical trials in newborns, evaluating its efficacy relative to the BCG vaccine. Simultaneously, the vaccine undergoes testing in HIV-negative and HIV-positive adults to establish safety and immune response, with the anticipation of extending these studies to include adolescents and adults in Sub-Saharan Africa in the future.

Esteban Rodriguez, CEO of Biofabri, underscored the importance of conducting trials in India, a nation home to 28% of global TB cases. He pointed out the pressing need for increased investment and efforts to combat TB, particularly in regions most affected by the disease. "Testing MTBVAC in India is a critical step towards addressing one of the leading causes of infectious death globally," Rodriguez stated.

Krishna Ella, Executive Chairman of Bharat Biotech, echoed this sentiment, highlighting the significant strides made with the commencement of clinical trials. "Our journey towards developing an advanced TB vaccine has reached a pivotal moment with today's launch of clinical trials in India," Ella remarked. "This achievement brings us closer to our goal of crafting vaccines that effectively prevent TB in adults and adolescents. Our collaboration with BioFabri stands as a testament to our commitment to this crucial cause."