Bharat Biotech International Gets CDSCO Panel Nod to Study Mycobacterium Tuberculosis Live Attenuated Vaccine

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved vaccine major Bharat Biotech International's proposal to conduct the Phase II clinical trial of Mycobacterium Tuberculosis (Live Attenuated) Vaccine to assess the safety and immunogenicity in healthy adolescent and adult populations.

This came after Bharat Biotech International presented a Phase I clinical trial report with 28 days of 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 and Diabetic subjects from the study. In addition, the expert panel 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 the day 28 and day 56 follow up and the same should be submitted to CDSCO at the time of Phase III clinical trial application.