New Delhi [India], May 7 : The Subject Expert Committee (SEC), which comes under the Central Drug Standard Control Organisation (CDSCO), has approved vaccine major Bharat Biotech International's proposal to conduct the Phase II clinical trials of Mycobacterium Tuberculosis (Live Attenuated) Vaccine to assess the safety and immunogenicity in healthy adolescent and adult populations.
According to sources, in the minutes of the meeting of Subject Expert Committee (SEC) held on March 30, 2024, the firm presented Phase I clinical trial report with 28 days safety results along with Phase II clinical trial protocol titled, "A Phase II,
randomized, double-blind trial to assess the Safety and Immunogenicity of MTBVAC (BBV169), with BCG vaccine as a comparator in Healthy adolescent and adult populations".
However, this approval is subject to the condition that the firm should revise the exclusion criteria by excluding HIV positive subjects, diabetic subjects, and Molecular based RT- PCR test should be performed instead of Sputum AFB smear test for diagnosis of TB.
The committee further added that DSMB review should be performed after day 28 and day 56 follow up and same should be submitted to CDSCO at the time of Phase III clinical trial application.
Accordingly, revised Phase II protocol should be submitted to CDSCO for approval.
Earlier, Bharat Biotech issued a press release "MTBVAC, the first vaccine against Tuberculosis derived from a human source, begins clinical trials in adults in India."
"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," it said.
"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," it said further.
Bharat Biotech International Limited in collaboration with Biofabri have started a series of clinical trials to evaluate the safety, immunogenicity and efficacy of MTBVAC in India.
Tuberculosis, which is transmitted through the respiratory tract, kills more than 1.6 million people and infects more than 10 million worldwide each year.
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