New Delhi:The AIIMS Ethics Committee has given its nod for a human clinical trial of the indigenously developed Covid-19 vaccine candidate Covaxin following which the premier hospital is set to begin the exercise by enrolling healthy volunteers from today.
Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS said, “The AIIMS Ethics Committee gave its approval for starting the human clinical trial of the indigenously developed Covaxin today. Healthy volunteers having no comorbid conditions and without a history of Covid-19, aged more than 18 years and less than 55 years, would be eligible to participate in the randomised, double-blind, placebo-controlled clinical trial”.
AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II human trials of Covaxin. In phase I, the vaccine would be tested on 375 volunteers and the maximum of 100 of them would be from AIIMS.
Rai, who is also the principal investigator of the study, said, “Few volunteers have already registered for the trial. We would start the screening of the individuals and evaluate their health condition from Monday onwards before vaccinating them.”
Anybody willing to participate in the trial can send an email to Ctaiims. [email protected] or an SMS to or call on 7428847499, he said. The institute may also put up these contact details on its website.
Rai said the Ethics Committee had raised few concerns in the protocol submitted for carrying out of the trial.
“Those concerns were addressed to following which the EC gave its approval to begin the trial by the premier institute,” he added.
Covid-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the Drugs Controller General of India (DCGI).