Countries across the world are in the race to develop a vaccine, and many of them, including India, are conducting human clinical trials to test the efficacy. The phase-I human clinical trial of Covaxin, India's first indigenously-developed vaccine against coronavirus, began at the All India Institute of Medical Sciences (AIIMS) in Delhi today.
THE FIRST DOSE
The first dose of the injection was 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 the screening of at least 22 people is underway.
"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. Sanjay Rai, Professor at the Centre for Community Medicine at AIIMS and the principal investigator of the study, said.
He told PTI that the first dose of 0.5 ml intramuscular injection was given to the man around 1.30 pm. Rai said no immediate side-effects have been observed since. He was under observation for two hours and will be monitored for the next seven days," he added.
A number of other participants will also be given the vaccine on Saturday after their screening reports come.
AIIMS-Delhi is among the 12 sites shortlisted by the Indian Council for Medical Research (ICMR) for conducting phase I and II randomised, double-blind, placebo-controlled clinical trials of Covaxin.
COVAXIN HUMAN CLINICAL TRIALS AT AIIMS: PHASE 1
At least 375 volunteers will be administered the vaccine in Phase I. The maximum of 100 of them would be from AIIMS. Phase 1 of the 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.
COVAXIN HUMAN CLINICAL TRIALS AT AIIMS: PHASE II
The second phase will have around 750 volunteers from all 12 sites together. These will be recruited between 12-65 years, AIIMS Director Dr Randeep Guleria said.
Already, around 1,800 volunteers have registered themselves for the trial at AIIMS, he said.
"In the first phase we see the safety of the vaccine which is of primary importance and the dose range is also calculated," he said.
There are three formulations of the vaccine, and 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, according to Rai.
COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the Drugs Controller General of India (DCGI). (With PTI inputs)