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.
MTBVAC is a global public-private project that will be a milestone in the field of vaccinology and in the approach to this highly communicable disease global epidemic with high morbidity and mortality. MTBVAC is one of the most promising vaccine candidates in the current global TB vaccine pipeline. The only currently available TB vaccine, the Bacillus Calmette-Guérin vaccine (BCG), was developed 100 years ago and has limited efficacy in preventing pulmonary TB in adults, who, along with adolescents, are the biggest spreaders of the disease.
The committee noted the Phase I Clinical trial report results with 28 days of safety results as per the approved protocol.
After detailed deliberation of the Phase II protocol, the committee recommended the grant of permission to conduct Phase II clinical trial as per protocol presented with the following conditions:
1) Exclusion criteria should be revised to mention clearly(a) HIV-positive subjects will be excluded from the study.(b) Diabetic subjects will be excluded.2) Molecular-based RT-PCR test should be performed instead of Sputum AFB smear test for diagnosis of TB.3) DSMB 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.
Accordingly, the expert panel stated that the revised Phase II protocol should be submitted to CDSCO for approval.
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