New Delhi: Bharat Biotech International Ltd announced the commencement of clinical trials for the Tuberculosis (TB) vaccine Mtbvac on adults in India.
The vaccine, developed by the Spanish biopharmaceutical company Biofabri, marks a significant milestone in combating TB, particularly in a country like India where a substantial portion of global TB cases are reported.
Mtbvac is being developed with dual objectives: to provide a more effective and durable alternative to the Bacillus Calmette Guérin (BCG) vaccine for newborns, and to offer protection against TB for adults and adolescents, for whom no effective vaccine currently exists. The trials are being conducted by Bharat Biotech in collaboration with Biofabri.
Esteban Rodriguez, CEO of Biofabri, emphasized the importance of testing the vaccine in adults and adolescents, given that India accounts for 28% of the world's TB cases. TB remains a significant cause of mortality globally, with India being particularly affected.
Krishna Ella, Executive Chairman of Bharat Biotech, expressed optimism about the progress made in developing a more effective TB vaccine. He highlighted the significance of conducting clinical trials in India, underscoring the company's commitment to preventing TB in adults and adolescents.
The Mtbvac vaccine has undergone several milestones before entering clinical trials in India.
Following the completion of a Phase-2 dose finding trial, a Phase-3 clinical trial was initiated in 2023 to compare the vaccine with the current BCG vaccine in newborns. The trial involves vaccinating thousands of newborns from South Africa, Madagascar, and Senegal, with over 1,900 babies vaccinated to date.
The pivotal safety, immunogenicity, and efficacy trials for Mtbvac are scheduled to commence in 2025, aiming to assess the vaccine's effectiveness in preventing TB in adults and adolescents. This initiative represents a significant step forward in the global effort to combat TB and reduce its burden, particularly in high-burden countries like India.