Health
Bharat Biotech begins clinical trials of tuberculosis vaccine in adults in India
This is the first human tuberculosis vaccine from a Spanish biopharmaceutical company. biofabriThis is stated in a press release from Bharat Biotech.
The release states that Mtbvac is being developed for two purposes. First, as a potentially more effective and longer-lasting vaccine than BCG (Bacillus Calmette-Guérin) for newborns, and second, as a prevention for tuberculosis in adults and adolescents, for which no effective vaccine currently exists.
The trial will be conducted by Bharat Biotech in close collaboration with Biofabri. Trials to evaluate the safety and immunogenicity of Mtbvac have begun with a pivotal safety, immunogenicity and efficacy study scheduled to begin in 2025, the release said.
Testing adults and adolescents is a major step in the country, where 28 percent of the world's tuberculosis cases are concentrated.
Esteban Rodríguez, CEO of Biofabri, said tuberculosis remains one of the leading infectious causes of death in the world, especially in India. Krishna Ella, Executive Chairman, Bharat Biotech, said: “The quest for a more effective vaccine against tuberculosis received a major boost today with clinical trials in India. Our goal of developing a vaccine has taken a major step forward today.” ”
The Mtbvac vaccine has passed several milestones before entering clinical trials in India. After the recent completion of a Phase 2 dose-finding study, a double-blind, controlled Phase 3 clinical trial in neonates will begin 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. More than 1,900 infants have been vaccinated to date, the statement added.
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Sources 2/ https://timesofindia.indiatimes.com/business/india-business/bharat-biotech-begins-clinical-trials-of-tb-vaccine-on-adults-in-india/articleshow/108750528.cms The mention sources can contact us to remove/changing this article |
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