The phase-I human clinical trial of India’s first indigenously-developed vaccine against novel coronavirus, Covaxin, began at the AIIMS in New Delhi on Friday.
The first dose of the injection was given to a 30-year-old man.
Already, 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, 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,” Rai said.
- In phase I, the vaccine would be tested on 375 volunteers and the maximum of 100 of them would be from AIIMS.
- The second phase would include around 750 volunteers from all 12 sites together.
- In the second phase, 750 people will be recruited between 12-65 years.
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, acording 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).
