The COVID-19 vaccine candidate Covaxin is developed by Bharat Biotech (representation)
New Delhi:
The phase I human clinical trial of the first vaccine developed in India against the novel coronavirus, Covaxin, began on Friday in Delhi AIIMS and the first dose of the injection was given to a man in his 30s.
More than 3,500 volunteers have signed up for the AIIMS trial since last Saturday, of which at least 22 are being screened, said Dr Sanjay Rai, professor at the AIIMS Community Medicine Center and principal investigator of AIIMS. study.
“The first volunteer, a Delhi resident, was screened two days ago and all of his health parameters were found to be within the normal range. He also does not have any comorbid conditions.
“The first dose of 0.5 ml intramuscular injection was given to him at around 1:30 p.m. No immediate side effects have been observed so far. He has been observed for two hours and will be monitored for the next seven days. next few days, ”Dr Rai said.
Few of the participants will receive the vaccine on Saturday after receiving their screening reports.
AIIMS-Delhi is one of 12 sites selected by the Indian Council for Medical Research (ICMR) to conduct Phase I and II of the randomized, double-blind, placebo-controlled clinical trials of Covaxin.
In phase I, the vaccine will be tested on 375 volunteers and a maximum of 100 of them will come from AIIMS. The second phase will include around 750 volunteers from the 12 combined sites, Dr Rai said.
Phase I of the vaccine trial will be conducted in healthy people between the ages of 18 and 55 who do not have co-morbid conditions. Women without pregnancy will also be selected to be part of the trial in the first phase.
In the second phase, 750 people will be recruited between the ages of 12 and 65, said AIIMS director Dr Randeep Guleria.
Already, around 1,800 volunteers have signed up for the AIIMS trial, he said.
“In the first phase we see the safety of the vaccine which is of paramount importance and the dose range is also calculated,” he said.
There are three vaccine formulations, and each subject will receive any one of the formulations in two doses two weeks apart. The first 50 will receive the lowest dose of the vaccine. If they are found to be safe, they will be given to 50 other patients in high doses, according to Dr Rai.
The COVID-19 vaccine candidate Covaxin, developed by Hyderabad-based Bharat Biotech in collaboration with ICMR and the National Institute of Virology (NIV), had recently obtained approval for human clinical trials from the Drugs Controller General of India (DCGI).
