In a bid to help the country fight the tuberculosis menace, Hyderabad-based vaccine manufacturer Bharat Biotech will spearhead clinical trials of the Spanish tuberculosis vaccine MTBVAC in India. The trials are carried out in close collaboration with Spanish biopharmaceutical firm Biofabri with whom Bharat Biotech signed a partnership in 2022 to development and manufacture the vaccine.
According to World Health Organisation, India has the highest number of tuberculosis infections, accounting to almost a quarter of the world’s TB cases.
“Trials to evaluate the safety and immunogenicity of MTBVAC have started with a pivotal safety, immunogenicity and efficacy trial planned to start in 2025,” Bharat Biotech said.
It may be recalled that the only vaccine in use today, BCG (Bacillus Calmette and Guérin), is an attenuated variant of the bovine TB pathogen. 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.
BCG is more than a hundred years old and has limited effect on pulmonary tuberculosis, which is responsible for the transmission of the disease, the Hyderabad company 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» 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,” said Biofabri’s Chief Executive Officer Esteban Rodriguez.
After the recent completion of a Phase 2 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. Around 7,000 newborns from South Africa, 60 from Madagascar and 60 from Senegal will be vaccinated.
As part of the different Phases of the trial, so far about 1,900 babies were administered with the vaccine candidate, according to the company.
MTBVAC’s safety and immunogenicity is also being evaluated in HIV-negative and HIV-positive adults and adolescents.
The Phase 2 HIV safety study is carried out by HIV Vaccine Trials Network (HVTN), the company said.
“Our goal to develop TB vaccines to prevent disease in adults and adolescents has taken a big step today,” Bharat Biotech’s Executive Chairman Dr Krishna Ella said.