Man given first dose as Phase-I human clinical trial of Covaxin begins at AIIMS Delhi

In a recent development, The phase-I human clinical trial of India's first indigenously-developed vaccine against novel coronavirus, Covaxin, began at the AIIMS here on Friday with the first dose of the injection given to a man, who is in his 30s.

Over 3,500 volunteers have registered themselves for the trial at AIIMS since last Saturday, of whom at least 22 are being screened, Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS and the principal investigator of the study, said.

"The first volunteer, a resident of Delhi, was screened two days ago and all his health parameters were found to be within the normal range. He also does not have any co-morbid conditions.

"The first dose of 0.5 ml intramuscular injection was given to him around 1.30 pm. No immediate side-effects have been observed so far. He was under observation for two hours and will be monitored for the next seven days," Dr Rai said.

“There are three formulations of the COVID-19 vaccine candidate. Each subject will be given any one of the formulations in two doses two weeks apart. The first 50 will get the lowest strength dose of the vaccine. If it is found to be safe in them, then it will be given to another 50 patients in high doses,” added Dr. Rai.

The vaccine has been developed by the Hyderabad-based pharmaceutical company in collaboration with National Institute of Virology (NIV) and Indian Council of Medical Research (ICMR). AIIMS, Delhi was selected by the ICMR for conducting phase I and II trials. Covaxin has been derived from a strain of the novel coronavirus isolated by the National Institute of Virology in Pune.

According to the Indian Council for Medical Research (ICMR), the trial is taking place at 12 sites for phase I and II randomised, double-blind, placebo-controlled clinical trials of Covaxin.

Apart from AIIMS Delhi, trials are taking place at AIIMS Patna and a few other sites.

"Any healthy individual who wishes to participate in the trial can send in an email on [email protected] or send an SMS or call on 7428847499," the AIIMS doctor said adding that for phases I & II phase- AIIMS (Delhi) will choose only 100 participants out of 375 volunteers and remaining participants will be studied at other sites.

The top drug regulator had earlier given its green signal for human clinical trials for Covaxin, which has been developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), Pune.

Written by Kumar Saurav, He is Journalism graduate from Indian Institute of Mass Communication New Delhi.

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