As soon as AIIMS announced to start the human trial of Covaxin, around 3,500 volunteers registered themselves for the same, of whom the screening of at least 22 people is underway, Dr Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS and the principal investigator of the study told news agency PTI.
“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," Dr Rai said.
He further informed that the first dose of 0.5 ml intramuscular injection was given to him around 1.30 pm and no immediate side-effects have been observed so far.
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The volunteer was under observation for two hours and will be monitored for the next seven days,” Rai said adding that more participants would be given the vaccine on Saturday after their screening reports come.
AIIMS-Delhi is among the 12 sites selected by the Indian Council for Medical Research (ICMR) for conducting phase I and II randomised, double-blind, placebo-controlled clinical trials of Covaxin.
The national medical institute had last week announced that it will begin human trials of India's first indigenous Covid-19 vaccine from next week on 100 healthy volunteers aged between 18 and 55.
These volunteers will be kept under observation for a period of nearly 150 days. Covaxin is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
According to Bharat Biotech, The Phase 1 clinical trial for Covaxin has been initiated across the country from July 15 onwards, and this is a randomised, double-blind, placebo-controlled clinical trial on 375 volunteers across the country.
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Rai also informed that the second phase would include around 750 volunteers from all 12 sites together.
Phase I of the vaccine trial will be done on healthy people aged 18-55 years having no co-morbid conditions. Women with no pregnancy will also be selected to be a part of the trial in the first phase.
There are three formulations of the vaccine, and each subject will be given any one of the formulation 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, according to Rai.
The Drug Controller General of India, Central Drugs Standard Control Organisation (CDSCO), and the Ministry of Health & Family Welfare granted permission to initiate Phase-I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.