Three Kolkata institutes queue up for corona vaccine trials – Times of India

Kolkata News

Image used for representational purpose

KOLKATA: The first lot of Covaxin, the indigenous Covid vaccine candidate, is expected to reach a city hospital — National Institute of Cholera and Enteric Diseases (NICED) — in about a week for phase III clinical trials that could, if all goes well, start as early as next month.
NICED is one of three Kolkata hospitals in the vanguard of the vaccine trials being conducted across the country, the other two being School of Tropical Medicine (STM) and College of Medicine & Sagore Dutta Hospital, where different vaccine candidates are scheduled to be tested shortly.
At NICED, as a part of the pan-India phase III trials of Covaxin being conducted across multiple centres, 1,000 volunteers will be part of the study, said Shanta Dutta, director, ICMR-NICED. “If all goes well, we should be able to kick of the trials by the first week of December,” she added.
As many as 28,500 volunteers across the country will be part of the third phase of the trial for Covaxin, developed by Bharat Biotech and ICMR.
The trial at NICED will be placebo-controlled: half the participants will receive inert placebos; the rest will be administered the vaccine candidate.
“Many have shown interest in volunteering for the study,” Dutta said. “We will soon start screening the volunteers to select those who fit our criteria.”
STM will be part of the phase III trial of Covovax, another Covid-19 vaccine candidate. The institute’s ethics committee is expected to meet on Tuesday to clear the decks for the trial. Here, 100 volunteers will be part of the trial. Many, including doctors, have expressed interest in becoming volunteers, said insiders.
Originally developed by US-based vaccine manufacturer Novavax, Covovax is the Indian version of the original vaccine formulated at Serum Institute of India (SII) in collaboration with Novavax. In addition to SII and Novavax, ICMR will be sponsoring the trial at STM.
Unlike other vaccine trials, no placebo will be given to volunteers at the STM study.
Sources at the hospital said this would be a ‘two-arm trial’, where all volunteers will be given active vaccines: either SII’s Covovax or NVX-CoV2373 by Novavax.
“While the trials at NICED and STM have been finalized, we are open to any good proposal for Covid vaccine trials,” said Narayan Swaroop Nigam, the state health secretary.
The trial at Sagar Dutta hospital — of the Russian Sputnik V — will be part of a pan-India clinical trial being conducted by Indian pharma company Dr Reddy’s.
Dr Reddy’s Lab has joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V, as well as its distribution.
“An expert team has been asked to look into the proposal of conducting stage III trials at the hospital,” said a senior health department official.
“Of the more than 150 Covid-19 candidate vaccines that are at various pre-clinical or clinical development stages, nine are either undergoing, awaiting or just completing phase III trials. These belong to four broad categories, based on their mode of discovery. Covovax is a protein-based nanoparticle (virus-like protein) vaccine. It is likely to be a safer vaccine as it contains a synthetic protein component and not a whole virus nor a carrier (vehicle) virus,” said Santanu Kumar Tripathy, who heads the department of clinical and experimental pharmacology at STM.
Covaxin is an inactivated whole-virus vaccine which uses a fully destroyed virus. Sputnik V falls into the category of viral vector vaccine, in which another virus is used to carry the DNA encoding of the needed immune response.