The AIIMS Ethics Committee on Saturday gave its nod for a human clinical trial of the indigenously developed COVID-19 vaccine candidate Covaxin following which the premier hospital is likely to begin the exercise by enrolling healthy volunteers from Monday.
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 a maximum of 100 of them would be from AIIMS.
"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," Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS 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," Rai, who is also the principal investigator of the study, said.
Anybody willing to participate in the trial can send an email to Ctaiims.firstname.lastname@example.org or an SMS to or call on 7428847499, he said. The institute may also put up these contact details on its website.
According to Rai, the Ethics Committee had raised few concerns in the protocol submitted for carrying out of the trial.