Bharat Biotech Innovates: TB Vaccine Trials Initiated in India

In Hyderabad, Bharat Biotech International Ltd announced the commencement of clinical trials for the Mtbvac tuberculosis vaccine on adult subjects in India. This groundbreaking vaccine, originating from human sources, is a product of the Spanish biopharmaceutical firm, Biofabri, as detailed in a press release by Bharat Biotech.

The Mtbvac vaccine is being developed with dual objectives: firstly, to serve as a more potent and potentially enduring alternative to the conventional BCG (Bacillus Calmette-Guérin) vaccine for newborns; and secondly, to combat tuberculosis among adults and adolescents, demographics currently lacking an efficacious vaccine.

These trials are being conducted in close collaboration between Bharat Biotech and Biofabri. A comprehensive assessment of the safety, immunogenicity, and efficacy of Mtbvac is underway, with plans for a pivotal trial slated to commence in 2025, according to the release.

This endeavor marks a significant stride forward, particularly in a nation where 28% of the global tuberculosis burden is concentrated. Tuberculosis continues to rank among the foremost infectious causes of mortality worldwide, with India being disproportionately affected, remarked Esteban Rodriguez, CEO of Biofabri.

Krishna Ella, Executive Chairman of Bharat Biotech, expressed optimism about advancing the quest for a more potent tuberculosis vaccine with the initiation of clinical trials in India. The endeavor to develop vaccines against tuberculosis for the prevention of disease in adult and adolescent populations has gained substantial momentum today.

Prior to embarking on clinical trials in India, the Mtbvac vaccine achieved several key milestones. Following the recent completion of a Phase-2 dose-ranging study, a double-blind controlled Phase-3 clinical trial in newborns was initiated in 2023, aimed at comparing the vaccine’s efficacy against the incumbent BCG vaccine.

The vaccination regimen will encompass 7,000 newborns from South Africa, along with 60 each from Madagascar and Senegal. Notably, over 1,900 infants have already received the vaccine, as highlighted in the press release.