The All India Institute of Medical Sciences (AIIMS) in Delhi will start enrolling healthy individuals from Monday for conducting the human clinical trial of Covaxin, the indigenously developed Covid-19 vaccine candidate.
This comes after AIIMS’s Ethics Committee gave its nod for a human clinical trial of Covaxin on Saturday.
AIIMS Delhi is among the 12 institutes selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II human trials of Covaxin. The vaccine would be tested on 375 volunteers during phase I and the maximum of 100 of them would be from AIIMS.
“We are launching the enrollment process from Monday. We are going to select healthy participants with no comorbidities and without a history of Covid-19,” Dr Sanjay Rai, a professor at AIIMS’ Centre for Community Medicine, said, according to news agency ANI.
Any healthy individual, who wishes to participate in the trial, can send in an email on Ctaiims.covid19@gmail.com or send an SMS or call on 7428847499.
“The age group of the study population is 18 to 55 years. This would be a randomised, double-blind, placebo-controlled clinical trial,” he said.
He said that in the first and second phase AIIMS Delhi will choose only 100 participants out of 375 volunteers and the remaining will participate at other sites.
“We have already registered a few volunteers for the trial. From Monday onwards, our team will start their health screening before giving them vaccination,” he said.
Covaxin, India’s first potential indigenous Covid-19 vaccine, has been jointly developed by the Indian Council of Medical Research (ICMR) and Bharat Biotech International Limited (BBIL).
Hyderabad-based Bharat Biotech is among the seven Indian firms working on Covid-19 vaccines. It was the first to get the regulatory nod to begin phase 1 and phase 2 human trials to test the vaccine for efficacy and safety.
Bharat Biotech said in a statement on Friday that this is a randomised, double-blind placebo-controlled clinical trial with 375 volunteers. Bharat Biotech has said that human trials of Covaxin started on July 15.
“Eventually, we plan to enrol 1,125 for both phase I and II. The human clinical trials commenced at AIIMS, Patna,” the statement said.
Zydus Cadila has also got an approval from the Drugs Controller General of India (DCGI) for human clinical trials for ZyCov-D, its indigenously developed vaccine candidates against Sars-Cov-2, which causes Covid-19.