The All India Institute of Medical Sciences is likely to submit a proposal to start phase 3 clinical trials in the hospital to the Institute of ethics committee for Bharat Biotech’s anti Coronavirus (Covid-19) vaccine candidate by early next week.
Bharat Biotech last week got an approval from drugs controller general of India to conduct phase 3 clinical trials of its anti Covid-19 vaccine candidate, Covaxin, in India, and AIIMS Delhi is one of the sites selected for trials that will be conducted across India.
“The proposal is being prepared for the phase 3 trials, and within a couple of days we will be submitting it to the institute ethics committee for approval,” confirmed Dr Sanjay Rai, professor, department of community medicine, AIIMS Delhi.
Dr Rai is also the principal investigator for the Covaxin trials at the hospital.
For a trial to start at any of the approved sites, it is mandatory to secure clearance of the institute ethics committee.
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As per the rules laid down by country’s biomedical research regulator— the Indian Council of Medical Research (ICMR), it is required for an ethics committee to oversee clinical research and thoroughly review the proposal at any site before allowing the trial to start.
AIIMS ethics committee consists 15 members, and is expected to take about 10-14 days to grant the necessary approvals.
“The proposal will be at least 200-300 pages and it takes time to go through it properly. The idea is to review and look for gaps, if any, that would address all concerns. The concerns that are usually raised almost always are valid, which you might miss otherwise. It helps,” said Dr Rai.
For the phase 1 and 2 trials, Dr Rai’s team had submitted the proposal to the committee on June 30, and the clearance came through on July 18.
AIIMS plans to recruit anywhere between 2,000-5,000 participants for the upcoming phase 3 trial once they get the approval.
Bharat Biotech had submitted the phase 3 trial application for India to the national drugs controller on October 2, and received its approval on October 22, suggesting minor procedural changes to the trial plan.
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The company plans to enroll at least 26,000 participants for the phase 3 trials at 25 to 30 hospital sites across 13-14 states.
For phase 1 clinical trials, it had recruited 375 subjects, and as part of the phase 2 trials the vaccine candidate was administered to 400 participants.
Bharat Biotech has completed phase 1 trial, and the results were submitted to DCGI that showed no major safety concern. For phase 2, the safety test has been completed, and the immunogenicity test to know body’s immune response to the vaccine, is currently underway.
Covaxin is India’s first vaccine candidate against Covid-19. Bharat Biotech has developed the vaccine candidate in collaboration with ICMR- National Institute of Virology (NIV) using an inactivated Sars-Cov-2 virus, the virus that causes Covid-19.
“Phase 3 trial results will eventually decide which vaccine would work and which wouldn’t,” said Dr GC Khilnani, former head, pulmonary medicine department, AIIMS, Delhi.