The Indian Council of Medical Research (ICMR) and Serum Institute of India (SII) will conduct a virtual meeting with principal investigators of 17 trial sites across the country on Friday, to discuss how to go ahead with the Covishield vaccine trial.
ICMR officials told The Indian Express this was a routine meeting, which will touch upon aspects such as how to conduct the trial in strict compliance with protocols, apart from detailing the standard operating procedures, and other regulations.
The process of getting the ethics committee’s approvals, followed by site initiation visits and enrolling volunteers, is likely to take another two weeks, following which, the trial is expected to start between August 25 and 28, officials added.
The SII had received approval from the Drug Controller General of India to conduct phase two and three human clinical trials of the vaccine candidate – developed by Oxford University and biopharmaceutical firm AstraZeneca. The vaccine candidate is officially known as AZD1222, and has been developed by the Jenner institute – part of the Nuffield Department of Medicine at the University of Oxford. Pune-based SII, which has supported these efforts, has named the vaccine Covishield.
In Pune, there are four clinical trial sites which have been approved for the study. Dr Sanjay Lalwani, principal investigator for the clinical trial at Bharati Hospital, said their ethics committee approved the revised protocol on Wednesday, while Dr Ashish Bawdekar, principal investigator at KEM Hospital and Research Centre, said their ethics committee approved the revised protocol on Thursday.
“There will be a virtual meeting with principal investigators of all clinical trial sites on Friday,” Dr Lalwani said. “This is a routine meeting, where investigators will be trained about the observer-blind randomised controlled study that will determine the safety and immunogenicity of the Oxford vaccine on healthy Indian adults.”
Other trial sites include Jehangir Hospital and Sassoon General Hospital in Pune
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