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The clinical trials of MTBVAC, the Spanish tuberculosis vaccine candidate, the first live attenuated vaccine of Mycobacterium tuberculosis isolated from a human, commenced in India.
The trials are carried out by Hyderabad-based 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.
“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,’‘ Krishna Ella, Executive Chairman Bharat Biotech said.
After more than three decades of research, Esteban Rodriguez, CEO of Biofabri, 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 accumulates 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.’‘
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.
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 Phase 3 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 Phase 2 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 Phase 2b efficacy study in adolescents and adults is planned to start in the second half of 2024 in Sub-Saharan Africa.
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 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.
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