The Central Drug Standard Control Organisation’s (CDSCO) Subject Expert Committee (SEC) has approved Bharat Biotech International’s proposal to conduct the phase II clinical trial of the Mycobacterium Tuberculosis (Live Attenuated) Vaccine to assess the safety and immunogenicity in healthy adolescent and adult populations.
According to a release issued by the Company, the MTBVAC is the first vaccine against TB derived from a human source to begin clinical trials in adults in India.
“Studying the safety, immunogenicity, and efficacy of MTBVAC in the most populated country in the world and the one with the highest number of cases of this infectious disease is key to continue advancing in this vaccine. Bharat Biotech International Limited in collaboration with Spanish biotechnology company Biofabri have started a series of clinical trials to evaluate the safety, immunogenicity, and efficacy of MTBVAC in India. MTBVAC is being developed for two purposes - as a more effective and potentially longer-lasting vaccine than BCG for newborn children, and for the prevention of TB in adults and adolescents, for whom there is currently no effective vaccine,” the statement said.
It added that 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, 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.
“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,” the statement by the Company added.
Meanwhile, the most recent announcement by the SEC on the next stage of trial comes with the condition that the firm should revise the exclusion criteria and the expert panel also suggested performing Molecular-based RT-PCR (Real-Time Reverse Transcription – Polymerase Chain) tests instead of Sputum AFB (Acid-Fast Bacilli) smear tests for diagnosis of TB. The committee further added that DSMB (Data and Safety Monitoring Board) review should be performed after day 28 and day 56 follow up and the same should be submitted to CDSCO at the time of phase III clinical trial application.
At the recent SEC meeting for the vaccine held on April 30, 2024, the expert panel reviewed the phase I clinical trial report with 28 days of safety results along with the phase II clinical trial protocol titled “A phase II, randomised, double-blind trial to assess the Safety and Immunogenicity of MTBVAC (BBV169), with BCG vaccine as a comparator in Healthy adolescent and adult populations”.
