Covid-19: Corbevax Phase 3 trial at JJ, but five hospitals in Maharashtra miss chance

PUNE: Five out of the seven hospitals in Maharashtra chosen as sites for Biological E’s Corbevax Phase 3 clinical study missed out on the opportunity, said authorities.
Officials from the selected hospitals in Pune, Mumbai and Nagpur said the trial investigators recently emailed them about reaching the limit of trial volunteers before these sites could get the necessary documentation in place as well as the Ethics Committee approval.
An official from Biological E in Hyderabad declined comment on the matter, citing confidentiality.
According to the information on Clinical Trials Registry - India (CTRI), the Phase 3 clinical study to evaluate the immunogenicity and safety of Biological E’s Corbevax vaccine for protection against Covid was to be conducted at 30 sites, including seven in Maharashtra. Only two hospitals in the state — Grant Medical College and Sir JJ Hospital in Mumbai, and Mahatma Gandhi Institute of Medical Sciences in Wardha — could participate in the Phase III trial for adults.
This was the first time in Maharashtra that a trial for Corbevax, India’s third indigenous vaccine against Covid-19, was to be conducted for adults. Phase 1 and 2 trials of the vaccine were conducted at sites in other states.
Hospitals earlier chosen from Pune were YCM Hospital and BJ Government Medical College, and Sassoon General Hospitals College. In Mumbai, three hospitals were selected: Grant Medical College and JJ Hospital, TN Medical College and BYL Nair Hospital, and Tata Memorial Centre.
An official from a hospital selected for the trial in Nagpur said: “Before we could complete the necessary paperwork and get an approval from the Ethics Committee, the sample size was achieved at other sites. We received a communication in October to not take the process forward further.”
The official said the enrolment was the first step of a clinical trial. “Different sites enter the study at different time during the trial period. The sample size is simultaneously calculated as and when volunteers are enrolled. There is no fixed site-specific volunteer number. If the sample size is 3,000, it is not necessary that all the sites should enrol an equal number of volunteers. Therefore, once the sample size was achieved in this case, other selected sites were asked not to go ahead with the process,” he said.
The principal investigator for the trial in a Mumbai hospital said: “We were in the process of getting the Ethics Committee approval, when we were informed that the volunteer enrolment process had been completed. It was in first week of October. Our site was thus not required to undertake the trial.”