Hederabad: Bharat Biotech International Ltd has embarked on clinical trials for the Tuberculosis vaccine MTBVAC on adults in India, marking a significant development in the fight against one of the deadliest infectious diseases globally.
Developed through a collaboration between the Spanish biopharmaceutical company Biofabri and Bharat Biotech, headquartered in Hyderabad, MTBVAC is derived from a strain of Mycobacterium tuberculosis found in humans, according to a press release issued by the company.
The trials are being conducted by Bharat Biotech in close partnership with Biofabri. Following the completion of a dose escalation trial in HIV uninfected adults, a Phase 2 study in HIV-infected adults has commenced in 2024 to assess the safety of MTBVAC in this population.
The companies view this vaccine as a potential milestone in global vaccinology, highlighting it as an example of public-private, national, and international collaboration.
The MTBVAC vaccine is considered a promising alternative to the current tuberculosis vaccine, BCG, which has been administered to newborns for over a century. While BCG offers limited protection against pulmonary TB, MTBVAC holds promise for a more efficient and long-term solution.
The trials, aimed at evaluating the safety and immune response of MTBVAC, have commenced, with a pivotal safety, immune response, and efficacy trial scheduled for 2025.
The initiation of clinical trials in India, a country where 28 percent of the world’s tuberculosis cases are concentrated, marks a significant advancement in TB research.
Before commencing clinical trials in India, the MTBVAC vaccine achieved several crucial milestones. A Phase 2 trial to determine the optimal dosage was recently completed, followed by the initiation of a double-blind controlled Phase 3 clinical trial in newborns in 2023. This trial seeks to compare the efficacy of MTBVAC with the existing BCG vaccine.
TB remains a leading infectious cause of death worldwide, particularly in India, remarked Esteban Rodriguez, CEO of Biofabri.
Krishna Ella, Executive Chairman of Bharat Biotech, expressed optimism about the progress, stating, “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 release also disclosed plans to vaccinate 7,000 newborns from South Africa, along with 60 from Madagascar and Senegal each. Notably, more than 1,900 babies have already received the vaccine as part of the ongoing efforts.
