The release said that Mtbvac is being developed for two purposes; firstly, as a more effective and potentially longer-lasting vaccine than BCG ( Bacillus Calmette Guerin) for newborns and secondly, for the prevention of TB in adults and adolescents, for whom there is currently no effective vaccine.
The trials are carried out by Bharat Biotech in close collaboration with Biofabri. Trials to evaluate the safety and immunogenicity of Mtbvac have started with a pivotal safety, immunogenicity and efficacy trial which has been planned to start in 2025, the release said. It is a giant step to test in adults and adolescents in the country where 28 per cent of the world’s TB cases accumulate.
TB remains one of the world’s leading infectious causes of death, especially in India, Esteban Rodriguez, CEO of Biofabri said. Krishna Ella, Executive Chairman Bharat Biotech said “Our quest for a more effective vaccine against Tuberculosis received a big boost today, with clinical trials in India. Our goal to develop TB vaccines to prevent disease in adults and adolescents has taken a big step today.”
The Mtbvac vaccine has passed several milestones before entering clinical trials in India. After the recent completion of a Phase-2 dose finding trial, a double-blind controlled Phase-3 clinical trial in newborns has been started in 2023 to compare the vaccine with the current BCG vaccine.
As many as 7,000 newborns from South Africa, 60 from Madagascar and 60 from Senegal will be vaccinated. To date, more than 1,900 babies have been vaccinated, the release added.
