PGIMER Chandigarh has been chosen as one of the 17 sites in India to conduct phase 2 and 3 clinical human trials of the Oxford University-Astra Zeneca Covid-19 vaccine (Covishield).
The trials are expected to begin by August-end after recruiting 250 volunteers.
Phase 2 and 3 trials will be done on larger population
Citing the promising results of phase 1 trials in UK, Prof. Jagat Ram, Director PGIMER said that the trials did not present any serious adverse side effects. Further, he added that Phase II and III trials will be done on a larger human population to see its efficacy.
PGIMER will further strengthen its capacities and a core group will be constituted to work out the modalities and form a comprehensive plan.
Ethics committee to review
The institute’s ethics committee will review the protocol keeping in view the safety of the patient, said Dr Madhu Gupta, Principal Investigator of the trials, PGIMER.
The committee will see the harms and the benefits and after approval, we will look for a site, recruit staff and start the trial.
Volunteers to be recruited
Volunteers will be recruited for carrying out the trial.
The institute will adopt a proper detailed procedure which is yet to be disclosed.
Around 1,600 volunteers will be tested across all the centers in India and PGI will recruit 250 individuals.
Dr Gupta said that PGIMER will mainly look at the safety of the vaccine during trial and not at its efficacy. It will check for antibody production in volunteers.
Dr. Gupta also added that there are more chances of antibody monitoring being done at National Institute of Virology, Pune.
Certain conditions have to be met
Dr. Gupta while sharing the eligibility conditions said that those volunteering for trials must be healthy and above 18 years of age. Further, in case, anyone is undergoing treatment for any disease currently or have Covid, then he/she won’t be eligible because side effects could result when the vaccine interacts with the health condition in an individual’s body.
Trial to start by third week of August
Dr. Gupta said after getting approval from the ethics committee, the institute will look for a site and then recruitment will start. Hopefully, by the end of August, trials will be started. It will continue for six months.
Also, two doses will be administered to the participant with a four-week gap between the two jabs.
Source: The Tribune, The Indian Express
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