Bharat Biotech Begins Clinical Trials Of TB Vaccine 'MTBVAC' On Adults In India

Hyderabad [India]: Bharat Biotech International Ltd has started clinical trials of the Tuberculosis vaccine MTBVAC on adults in India, the company said on Sunday.

As per Bharat Biotech, MTBVAC is the first vaccine against Tuberculosis derived from a human source by the Spanish biopharmaceutical company, Biofabri.

The trials are being 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.

The official release from Bharat Biotech said that MTBVAC is being developed for two purposes; firstly, as a more effective and potentially longer-lasting vaccine than BCG (Bacillus Calmette Guerin) for newborns and secondly, for the prevention of TB in adults and adolescents, for whom there is currently no effective vaccine.

Esteban Rodriguez, CEO of Biofabri while terming the trail as a 'giant step', said, "It is a giant step to test in adults and adolescents in the country where 28 per cent of the world's TB cases accumulate. More effort and funding is needed to combat TB, which remains one of the world's leading infectious causes of death, especially in India."

"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," Dr Krishna Ella, Executive Chairman of Bharat Biotech said.
As per the statement, 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. 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," it added.

The company further said that the MTBVAC is the only vaccine against tuberculosis in clinical trials based on a genetically modified form of the pathogen isolated from humans Mycobacterium tuberculosis which, unlike BCG, contains all the antigens present in strains that infect humans.
This vaccine was developed in the laboratory of the University of Zaragoza, which has been part of CIBERES since its creation, in collaboration with Dr Brigitte Gicquel of the Pasteur Institute in Paris. The University of Zaragoza has the Spanish biotechnology company BIOFABRI as an industrial partner.

Tuberculosis, which is transmitted through the respiratory tract, kills more than 1.6 million people and infects more than 10 million worldwide each year. In 90 per cent of TB infections, the immune system recognises and controls the bacillus without causing disease.

However, in 5-10 per cent of infected people, the bacillus develops tuberculosis, which is fatal in half of patients without treatment with several drugs over 6 months. If TB is in the lungs, it can find a free path to progress, multiply and spread the disease.