The All India Institute of Medical Sciences (AIIMS) in Delhi administered its first dose of Bharat Biotech's vaccine candidate against the novel coronavirus as part of its combined Phase 1 and 2 trials for the drug. The vaccine candidate was administered to a healthy 30 year old man.
One of the investigators of the trial and a professor of community medicine at AIIMS, Dr Puneet Misra, said, “The vaccine candidate was administered to the first trial participant - a healthy 30-year-old man - around noon on Friday. He was monitored for two hours to check for any adverse reactions. All trial participants will be monitored every day for the first seven days. They will then be followed-up on day 14 and day 28. They will be tracked for up to a year to observe any long-term impacts.”
The centre has received nearly 3,500 applications for the trials so far, and 100 healthy participants will be enrolled from among them. Participants have to be between the ages of 18 and 55 years. They should not have comorbidities like diabetes, hypertension, heart or kidney disease. The centres are conducting simultaneous phase 1 and phase 2 clinical trials to study the safety and immunogenicity of different doses and adjuvant combinations of the vaccine developed by the biotechnology company, in collaboration with the Indian Council of Medical Research’s National Institute of Virology.
“Our priority is safety and hence we need healthy participants. Those who are called in for the trial have to undergo a battery of tests to determine their general health. They are tested for a current infection using RT-PCR test and for past infections using an antibody test. Participants are given the vaccine only if they are free of Covid-19. For now, we are also selecting participants only from Delhi and the National Capital Region for the ease of follow-ups,” said Dr Misra. The vaccine is currently being administered in two doses - 0.3 and 0.5 microgram.
