Bharat Biotech commences clinical trials of Spanish tuberculosis vaccine in India

Clinical trials of the Spanish tuberculosis (TB) vaccine MTBVAC have begun in India.

Vaccine maker Bharat Biotech is conducting the trials in partnership with Spanish biopharmaceutical company Biofabri which is responsible for clinical and industrial development of the vaccine “developed in the laboratory of the University of Zaragoza, with Dr. Brigitte Gicquel of the Pasteur Institute, Paris”.

MTBVAC is the only vaccine against tuberculosis undergoing clinical trials based on a genetically modified form of Mycobacterium tuberculosis, the pathogen that causes the disease. Unlike the BCG vaccine, the new vaccine contains all “the antigens present in strains that infect humans”. While trials to evaluate safety and immunogenicity of MTBVAC in India have begun, a pivotal safety, immunogenicity and efficacy trial is planned in 2025, Bharat Biotech said in an announcement coinciding with World Tuberculosis Day.

Bharat Biotech will be conducting a Phase 3 trial as Biofabri has completed the Phase 1 and 2 trials in other countries, a spokesperson said. “The MTBVAC vaccine has passed several milestones before entering clinical trials in India,” executive chairman Krishna Ella said in a release.

Studying the safety, immunogenicity and efficacy of the vaccine in the most populated country and the one with the highest number of cases of the infectious disease is key to continue advancing this vaccine.

MTBVAC has been developed to be a more effective and potentially longerlasting vaccine than BCG for newborns and for prevention of TB in adults and adolescents, for whom there is currently no effective vaccine, the Hyderabadbased company said. “It is a giant step to test in adults and adolescents in the country where 28% of the world’s TB cases accumulate,” Biofabri CEO Esteban Rodriguez said.

BCG is an attenuated variant of the bovine TB pathogen and more than a hundred years old with a limited effect on pulmonary tuberculosis that is responsible for the transmission of the disease, he said.

MTBVAC has been developed for the prevention of TB in adults and adolescents