The human phase I clinical trial of the first novel vaccine developed in India against the novel coronavirus, Covaxin, started in Delhi AIIMS on Friday and the first dose of the injection was given to a man in his 30s.
More than 3,500 volunteers have registered for the trial at AIIMS since last Saturday, of which at least 22 are being screened, said Dr. Sanjay Rai, a professor at the AIIMS Center for Community Medicine and the study's principal investigator.
"The first volunteer, a Delhi resident, was examined 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."
"He was given the first dose of 0.5 ml intramuscular injection around 1:30 pm. So far no immediate side effects have been observed. He was under observation for two hours and will be monitored for the next seven days," he said. Dr. Rai.
Few participants will receive the vaccine on Saturday after their screening reports arrive.
AIIMS-Delhi is among 12 sites selected by the Indian Council for Medical Research (ICMR) to carry out phases I and II of Covaxin's randomized, double-blind, placebo-controlled clinical trials.
In phase I, the vaccine will be tested on 375 volunteers and the maximum of 100 of them will be from AIIMS. The second phase will include about 750 volunteers from the 12 sites together, 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 comorbid conditions. Women without pregnancy will also be selected to be part of the test in the first phase.
In the second phase, 750 people between the ages of 12 to 65 will be recruited, said AIIMS director Dr. Randeep Guleria.
Some 1,800 volunteers had already registered 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.
From NDTV News
From NDTV News
No comments:
Post a Comment