Bharat Biotech commenced clinical trial of MTBVAC vaccine in India

by Psu Connect
Date: 26-03-24

MTBVAC is the only vaccine for tuberculosis in clinical trials based on a genetically modified form of pathogen isolated from humans Mycobacterium TB which is unlike the BCG vaccine.

Bharat Biotech International Ltd said it started clinical trials of the Tuberculosis vaccine MTBVAC on adults in India. This is the first vaccine against Tuberculosis derived from a human source by the Spanish bio-pharmaceutical company, Biofabri.

The trials are initiated by Bharat Biotech in close collaboration with Biofabri, as per information. After completing a dose escalation trial in HIV uninfected adults, a Phase 2 study in HIV-infected adults started in 2024 to determine whether MTBVAC is safe in this population. The companies are optimistic that the new vaccine will be a milestone in global vaccinology and call it an example of public-private, national, and international collaboration.

Bharat Biotech will be conducting a Phase 3 trial as Biofabri has completed the Phase 1 and 2 trials in other countries. MTBVAC is the only vaccine for tuberculosis in clinical trials based on a genetically modified form of pathogen isolated from humans Mycobacterium TB which is unlike the BCG vaccine.

On the auspicious day of World Tuberculosis Day, March 24, Bharat Biotech has announced the evaluation of the trials for the safety and immunogenicity of MTBVAC in India, and similarly, a pivotal safety trial is planned in 2025.