New TB vax clinical trials begin in India | Hyderabad News

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HYDERABAD: The world’s first Mycobacterium tuberculosis vaccine (MTBVAC) from a human source has begun clinical trials in India to evaluate its safety, immunogenicity and efficacy. The live attenuated vaccine is for newborns, adolescents and adults, sources said.
The clinical trials in the most populated country in the world with the highest number of cases is key to continuing advancement of the vaccine, which has undergone over three decades of research, officials said.

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A pivotal safety, immunogenicity and efficacy trial is also planned for 2025, company officials said on Sunday. It is developed by Spanish biopharma player Biofabri in collaboration with Hyderabad-based Bharat Biotech, which will have exclusive global manufacturing rights.
MTBVAC is meant as a more effective and potentially longer-lasting vaccine than the over 100-year-old BCG (Bacillus Calmette and Guerin) vaccine for newborns as well as for prevention of TB in adults and adolescents, for whom there is currently no effective vaccine, the manufactures said. The existing BCG vaccine is an attenuated variant of the bovine TB pathogen and has limited effect on pulmonary tuberculosis responsible for disease transmission.
MTBVAC is currently the only TB vaccine undergoing clinical trials based on a genetically modified form of the pathogen, Mycobacterium tuberculosis, which, unlike BCG, contains all antigens present in strains that infect humans.
Biofabri CEO Esteban Rodriguez called it a “giant step to test in adults and adolescents in the country with 28% of the world’s TB cases. Bharat Biotech executive chairman Dr Krishna Ella added: “Our quest for a more effective vaccine against TB received a big boost today with clinical trials in India.”



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