In a significant stride forward in the battle against tuberculosis (TB), clinical trials for the groundbreaking MTBVAC vaccine commenced in India on Sunday. This marks a pivotal moment in combating one of the world’s deadliest infectious diseases, claiming over 1.6 million lives annually.
Developed through a collaboration between Biofabri and Hyderabad-based Bharat Biotech, MTBVAC offers a promising alternative to the century-old BCG vaccine, currently the sole TB vaccine available. Derived from a human strain of Mycobacterium tuberculosis bacteria, MTBVAC holds potential for enhanced and prolonged protection against pulmonary TB, the most prevalent and communicable form of the disease.
These clinical trials aim to evaluate the safety, immunogenicity, and efficacy of MTBVAC, addressing the urgent need for improved TB prevention measures. With over 10 million TB infections reported worldwide each year, India, burdened with the highest TB caseload globally, serves as a crucial testing ground for MTBVAC.
The trials will encompass assessments of safety, immune response, and efficacy in preventing TB among adults and adolescents. MTBVAC’s journey spans over three decades of rigorous research, with Phase 3 trials initiated in newborns in 2023, comparing its efficacy with the traditional BCG vaccine. Concurrently, trials in HIV-uninfected and HIV-infected adults are underway to evaluate safety and immunogenicity, with forthcoming efficacy studies planned for adolescents and adults in Sub-Saharan Africa.
Esteban Rodriguez, CEO of Biofabri, emphasized the significance of testing MTBVAC in India, a country bearing 28% of the world’s TB burden. He stressed the need for continued efforts and funding to combat TB, a leading cause of infectious death globally.
Krishna Ella, Executive Chairman of Bharat Biotech, hailed the trials as a pivotal milestone in the pursuit of a more effective TB vaccine. He expressed gratitude for the partnership with BioFabri and reaffirmed their commitment to developing vaccines to prevent TB in adults and adolescents.
MTBVAC’s development embodies a global public-private collaboration, with funding and support from entities such as the European Union, the International AIDS Vaccine Initiative (IAVI), and the National Institutes of Health in the United States.
As the trials progress, hopes are high for MTBVAC to emerge as a game-changer in the fight against TB, offering renewed hope for millions worldwide.