INDIA—Bharat Biotech, an Indian multinational biotechnology company headquartered in Hyderabad, has initiated clinical trials of MTBVAC in India, marking a significant milestone in tuberculosis (TB) vaccine development.
MTBVAC, derived from a human source, is the world’s first live-attenuated vaccine for Mycobacterium tuberculosis, originating from Spain
These trials are being conducted by Bharat Biotech in close collaboration with Biofabri, with the objective of evaluating the safety and immunogenicity of MTBVAC.
A pivotal trial encompassing safety, immunogenicity, and efficacy is planned to commence in 2025.
The primary goal is to assess the immunogenicity and efficacy of MTBVAC, administered intradermally to infants on the first day of life.
Bharat Biotech will hold exclusive global manufacturing rights for the live attenuated vaccine developed for newborns, adolescents, and adults.
MTBVAC is being developed as a potentially more effective and longer-lasting alternative to the Bacillus Calmette–Guérin vaccine (BCG vaccine), which is over a century old.
It aims to address the prevention of TB in newborns and adults and adolescents, for whom no effective vaccine currently exists.
While the existing BCG vaccine offers limited protection against pulmonary TB, the primary form responsible for disease transmission, MTBVAC seeks to offer enhanced efficacy.
The safety, immunogenicity, and efficacy studies of MTBVAC in India, the world’s most populous country and one with the highest number of TB cases, are crucial for advancing the vaccine’s development after over three decades of research.
In his speech, Esteban Rodriguez, CEO of Biofabri, emphasized on the significance of testing MTBVAC in adults and adolescents in a country where 28% of the world’s TB cases accumulate, highlighting the need for increased efforts and funding to combat TB.
Dr. Krishna Ella, Executive Chairman of Bharat Biotech, for his part , expressed honor in partnering with BioFabri, Dr. Esteban Rodriguez, and Dr. Carlos Martin in the noble effort to innovate TB vaccines.
He noted that this new vaccine addresses the quest for a more effective tuberculosis vaccine, with clinical trials in India aimed at preventing TB in adults and adolescents.
MTBVAC has achieved several milestones prior to its clinical trials in India, including completing a Phase 2 dose-finding trial and initiating a Phase 3 clinical trial in newborns in 2023.
The Phase 3 trial, involving 7,000 newborns from South Africa, 60 from Madagascar, and 60 from Senegal, compares the vaccine with the current BCG vaccine.
This Phase 3 neonatal project, partially funded by the European Union through its EDCTP program, is coordinated by Biofabri as part of a consortium that includes several esteemed institutions.
Furthermore, a Phase 2 study in HIV-infected adults commenced in 2024 to determine MTBVAC’s safety in this population. This ongoing trial in South Africa evaluates safety and immunogenicity in both HIV-negative and HIV-positive adults and adolescents.
Additionally, a Phase 2b efficacy study in adolescents and adults in Sub-Saharan Africa is scheduled to begin in the second half of 2024. These studies, led by the American institution IAVI, aim to assess the efficacy of MTBVAC.
The Phase 2 HIV safety study is conducted by the HIV Vaccine Trials Network (HVTN) and funded by the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and the Department of Health and Human Services (DHHS).
The Phase 2b efficacy study will be carried out by IAVI and funded by BMGF and Open Philanthropy.
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