Bharat Biotech begins clinical trials of Spanish TB vaccine, MTBVAC in India

New Delhi: MTBVAC, the Spanish tuberculosis vaccine, the first live attenuated vaccine of Mycobacterium tuberculosis isolated from a human, reaches a new milestone by starting clinical trials in India, the most populated country in the world and the one with the highest number of cases of this infectious disease.

The trials are carried out by Bharat Biotech in close collaboration with Biofabri. Trials to evaluate the safety and immunogenicity of MTBVAC have started with a pivotal safety, immunogenicity and efficacy trial planned to start in 2025.

After more than three decades of research, Esteban Rodriguez, CEO of Biofabri says: «It is a giant step to test in adults and adolescents in the country where 28% of the world’s TB cases accumulate» and concludes that more effort and funding is needed to combat TB, which remains one of the world’s leading infectious causes of death, especially in India.

It should be remembered that the only vaccine in use today, BCG (Bacillus Calmette and Guérin), is an attenuated variant of the bovine TB pathogen. It is

more than a hundred years old and has a very limited effect on pulmonary tuberculosis, which is responsible for the transmission of the disease, hence the need to make progress on this new vaccine, which will be a milestone in global vaccinology and is an example of public-private, national and international collaboration.

Dr. Krishna Ella, Executive Chairman Bharat Biotech added, “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. We are honoured to partner with BioFabri, Dr. Esteban Rodriguez and Dr. Carlos Martin in this noble effort to reinvent TB vaccines.”

A long process, an example of public-private collaboration

The MTBVAC vaccine has passed several milestones before entering clinical trials in India.

The first is that after the recent completion of a Phase2 dose finding trial, a double-blind, controlled Phase3 clinical trial in newborns has started in 2023, comparing the vaccine with the current BCG vaccine. 7,000 newborns from South Africa, 60 from Madagascar and 60 from Senegal will be vaccinated. To date, more than 1,900 babies have been vaccinated.

The aim is to assess the immunogenicity and efficacy of MTBVAC which is administered intradermally to infants on the first day of life.

Vaccination began at a time of setback in the global fight against TB. Health restrictions imposed during the COVID-19 pandemic led to an increase in infections and a decrease in diagnosis and treatment. As a result, annual TB deaths have risen to over 1.6 million.

This Phase3 neonatal project, partially funded by the European Union through its EDCTP (European & Development Countries Clinical Trial Partnership) programme, is being coordinated by Biofabri, as part of a consortium that also includes the University of Zaragoza (Unizar), TuBerculosis Vaccine Initiative (TBVI), The University of Cape Town (UCT)/SATVI, Wits VIDA Health Consortium (WHC), Stellenbosch University (SUN-FAMCRU), Enhancing Care Foundation (ECF), Center de Recherche Biomedicale Espoir Pour La Santé (CRB-EPLS, Senegal) and Institut Pasteur de Madagascar (IPM).

Another important milestone is that after completing a dose escalation trial in HIV uninfected adults, a Phase2 study in HIV infected adults has started in 2024 to determine whether MTBVAC is safe in this population. This ongoing trial at 16 sites in South Africa – involving the vaccination of 276 adults – is evaluating safety and immunogenicity in HIV-negative and HIV-positive adults and adolescents vaccinated with MTBVAC.

A Phase2b efficacy study in adolescents and adults is planned to start in the second half of 2024 in Sub-Saharan Africa.

The studies in adolescents and adults in Sub-Saharan African are led by the American institution IAVI. The Phase2 HIV safety study is carried out by HIV Vaccine Trials Network (HVTN) and is funded by the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS). The Phase2b efficacy study will be carried out by IAVI and will be funded by BMGF and Open Philanthropy.