Clinical trials of Spanish tuberculosis (TB) vaccine MTBVAC have begun in India.
Vaccine maker Bharat Biotech is conducting the trials in partnership with Spanish biopharmaceutical company Biofabri that 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 in clinical trials based on a genetically modified form of the pathogen isolated from humans Mycobacterium tuberculosis which, unlike the BCG vaccine, contains all the antigens present in strains that infect humans. While the trials to evaluate the 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 on March 24.
Bharat Biotech will be conducting Phase 3 trial as Biofabri has completed the Phase 1 and 2 trials in other countries, a spokesperson replied to a query.
“Our quest for a more effective vaccine against tuberculosis received a big boost today, with clinical trials in India. 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 being developed to be a more effective and potentially longer-lasting vaccine than BCG for newborns and for prevention of TB in adults and adolescents, for whom there is currently no effective vaccine, the Hyderabad-based 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 transmission of the disease, he said.
