The clinical trials of MTBVAC, a novel tuberculosis vaccine, commenced in India, marking a significant milestone in the fight against this deadly infectious disease. Developed by Biofabri in collaboration with Bharat Biotech, MTBVAC is derived from a human strain of Mycobacterium tuberculosis bacteria. It aims to provide a more effective and long-lasting alternative to the BCG vaccine, the only currently available TB vaccine.
The clinical trials will evaluate the safety, immunogenicity, and efficacy of MTBVAC in adults and adolescents. TB remains a major global health concern, claiming over 1.6 million lives annually and infecting more than 10 million worldwide. India, with the highest TB burden, serves as a crucial testing ground for MTBVAC.
MTBVAC's development is the culmination of over three decades of research. It has undergone Phase 3 clinical trials in newborns, comparing its efficacy with the BCG vaccine. Additionally, trials in HIV-uninfected and HIV-infected adults are underway to assess safety and immunogenicity, with plans for further efficacy studies in adolescents and adults in Sub-Saharan Africa.
The global public-private partnership supporting MTBVAC's development includes the European Union, American institutions such as the International AIDS Vaccine Initiative (IAVI), and the National Institutes of Health. Their contributions have been instrumental in funding and conducting various stages of the trials.