AIIMS Delhi, on Friday, has begun the phase-1 human clinical trials of the first indigenous vaccine candidate "COVAXIN" against novel coronavirus.
Reportedly, the first shot of the vaccine has been injected to a man, who is in his 30s.
The volunteer will be kept in observation for two hours in the hospital. He will then be sent home and be monitored for the next seven days, sources in the AIIMS said.
Already, more than 3,500 volunteers have registered themselves for the trial at AIIMS since last Saturday, of whom the screening of at least 22 people is still underway, said Dr. Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS and the principal investigator of the study.
“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.
Covaxin, being developed by the Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology, recently got the nod for human clinical trials from the Drugs Controller General of India.
AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research for Phase I and II randomised, double-blind and placebo-controlled clinical trials of Covaxin.
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In phase I, the vaccine would be tested on 375 volunteers and 100 of them, the highest, would be from AIIMS. The second phase, would include around 750 volunteers from all 12 sites.
Phase I of the trial will be done on healthy people, aged between 18 and 55 years, having no co-morbid conditions. Women with no pregnancy will also be selected for the trial in the first phase.
In the second phase, 750 people will be recruited and they will be between 12 and 65 years of age, he said.