Bharat Biotech Starts Clinical Trials of TB Vaccine MTBVAC Among Adults in India

The Hydreabad-based pharmaceutical company Bharat Biotech announced on Sunday that it has begun clinical trials of the Spanish anti-tuberculosis vaccine, called MTBVAC, among adults in India. MTBVAC is the first live attenuated vaccine of Mycobacterium tuberculosis isolated from a human. The trials are being carried out by Bharat Biotech in close collaboration with Biofabri. Trials to evaluate the safety and immunogenicity of MTBVAC have started, with a pivotal safety, immunogenicity, and efficacy trial planned to start in 2025.

"It is a significant step to test MTBVAC in adults and adolescents in the country where 28% of the world's TB cases occur," said Esteban Rodriguez, CEO of Biofabri. "More effort and funding is needed to combat TB, which remains one of the world's leading infectious causes of death, especially in India."

The only related vaccine currently in use is BCG (Bacillus Calmette–Guérin), which is an attenuated variant of the bovine tuberculosis pathogen. It is over 100 years old and has limited effect on pulmonary tuberculosis, which is responsible for disease transmission.

"Our quest for a more effective vaccine against tuberculosis received a major boost today with clinical trials in India," said Krishna Ella, executive chairman of Bharat Biotech. "Our goal to develop TB vaccines to prevent disease in adults and adolescents has achieved a major milestone today." Tuberculosis, which is transmitted through the respiratory tract, kills at least 1.6 million people and infects at least 10 million worldwide each year. In 90% of infections, the immune system recognizes and controls the bacillus without causing disease. However, in 5-10% of infected people, the bacillus develops into tuberculosis, which is fatal in half of patients without treatment. If the infection is in the lungs, it can spread easily, multiply and spread the disease.​