A new Tuberculosis (TB) vaccine candidate of Bharat Biotech International is on the verge of entering phase III clinical trials.

“Two separate Phase II trials of Mycobacterium Tuberculosis Vaccine (MTBVAC) of Bharat Biotech have been completed,” a source in the Hyderabad-based vaccine maker told businessline.

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Of the two trials, one was supported by The European & Developing Countries Clinical Trials Partnership (EDCTP) and was sponsored by Biofabri in infants in South Africa, while the other was sponsored by International AIDS Vaccine Initiative (IAVI) and supported by the US National Institutes of Health and the US Department of Defence through its Congressionally Directed Medical Research Program, the source added. 

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TB infects more than 20 per cent of the global population and is the second leading cause of deaths from infectious disease after Covid19. TB is a highly contagious disease where vaccines are seen as the ‘best’ solution to prevent disease, reduce transmission and combat multi-drug resistant strains.

If successful, the collaboration between Bharat Biotech and Biofabri (which was announced last year) is expected to result in the worldwide production and the supply of the future vaccine in more than 70 countries with a high TB incidence, such as India, country with the highest TB burden in the world, with a 25 per cent of all cases.

“MTBVAC is being developed for two purposes – as a more effective vaccine than Bacille Calmette-Guerin (BCG) for newborns and for the prevention of TB disease in adults and adolescents, for whom there is currently no effective vaccine. It has a unique feature of preventing transmission or spread of the disease,’‘ the source said. 

Safety study

With the completion of phase II trials, Bharat Biotech is now planning to take up Phase II safety/immunogenicity study of the vaccine in people living with HIV (PWHIV) soon. The phase III trials of it will follow. 

 MTBVAC is being seen by the industry is one of the `promising’ vaccine candidates in the current global TB vaccine pipeline. “The only currently available TB vaccine, the Bacillus Calmette-Guérin vaccine (BCG), was developed 100 years ago and has limited efficacy in preventing pulmonary TB in adults, who, along with adolescents, are the biggest spreaders of the disease. 

Apart from Bharat Biotech’s Mycobacterium Tuberculosis Vaccine, currently there is only one vaccine candidate developed by GSK along with Aeras and the International AIDS Vaccine Initiative (IAVI)- M72- is likely to enter phase III trials in 2024. Bharat Biotech will be ahead in the race for phase III trials if it begins them soon.