KOLKATA: The phase III clinical trial of Sputnik V — the Russia-made candidate vaccine for Covid-19 — will be conducted in the city at Peerless Hospital. The institute is expecting a DCGI (Drug Control General of India) clearance soon for it to start from the first week of January.
The hospital’s ethics committee met on Thursday and approved the trial. “The phase III trial of Sputnik V vaccine will be conducted on 1,500 healthy volunteers from acro-ss the country,” said Snehendu Koner, head of business development with CliniMed LifeSciences, a site management organization for drug and vaccine trials which is looking after site selection in Bengal on behalf of Dr Reddy’s, the pharma major that has joined hands with Russian Direct Investment Fund (RDIF) for the trial of Sputnik V, as well as its distribution in India. “It will involve 100 volunteers at Peerless,” he added.
The approval by the hospital’s ethics committee will be forwarded to Dr Reddy’s on Friday. The latter, in turn, will forward it to the DCGI.
“We will start the trial once we get DGCI’s nod. The vaccines should hopefully arrive by the first week of January,” said Subhrojyoti Bhowmick, clinical research director at Peerless Hospital, who will be the principal investigator of the trial.
Like the Covaxin phase III trial, currently on at ICMR-NICED Kolkata, the Sputnik V trial will be double-blinded placebo-controlled, where half of the volunteers would get the actual vaccine and the others a placebo. The Covaxin trial period is a year, but the Spuntnik V trial woluld be a six-month study.
“Each volunteer will get a second shot 21 days after the first shot. There will be an antibody test on day 42, and the volunteer will be followed up for 180 days,” said Bhowmick.
Koner said the volunteers who get the placebo “would not be denied the actual vaccine after analysis of the trial opens up.”
CliniMed LifeSciences has already started mobilizing volunteers in anticipation. Peerless, too, will start enrolling volunteers. Apart from Peerless, 15 other sites across the country would be conducting phase III trials of Sputnik V on a total of 1,500 volunteers.
College of Medicine and Sagore Dutta Hospital was the first institute in Bengal that was selected for phase II trial of this candidate vaccine. But the government-run medical college missed the phase II trial as approvals did not arrive on time. But it is likely to be part of the phase III trial as the college’s ethics committee meeting is likely to take place soon.