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Clinical trials for Covaxin start at PGIMS-Rohtak; 3 given doses
The Phase-1 of human clinical trials for Covaxin — one of the two indigenous vaccine candidates for Covid-19— started at the Post Graduate Institute of Medical Sciences
The Phase-1 of human clinical trials for Covaxin — one of the two indigenous vaccine candidates for Covid-19— started at the Post Graduate Institute of Medical Sciences (PGIMS)-Rohtak on Friday. Haryana’s health minister Anil Vij took to Twitter to break the news on Friday afternoon.
“Human trial with Corona vaccine (COVAXIN) of Bharat Biotech started at PGI Rohtak today. Three subjects were enrolled today. All have tolerated the vaccine very well. There were no adverse efforts (sic),” wrote Vij on Twitter.
Covaxin is an indigenous Covid-19 vaccine, which is being developed by Bharat Biotech and ICMR’s National Institute of Virology, Pune. It is one of the two Indian vaccine candidates that have received the Drug Controller General of India’s nod to proceed with the Phase-1 and Phase-2 human clinical trials. In Rohtak, the sample size for Phase-1 trials is expected to around 8 to 10 people, officials said. In the past 10 days since PGIMS-Rohtak began enrolling subjects for trials, close to 100 individuals from Haryana have registered to be a part of the study.
Officials at PGIMS Rohtak said that 22 of these volunteers have already been screened for their medical history, and three of them received the vaccine on Friday.
Human dosing began at 10:30am, when one of the three subjects was first given a 3ug dose of Covaxin, via an intramuscular injection. After observing the subject for 30 minutes, the remaining two subjects received their vaccine doses between 11am and 12pm. “The subjects are in the age group of 22 to 35. They were kept under observation at PGIMS for three hours before being sent home. During follow-up calls in the evening, the subjects were not showing any adverse reactions. We are quite relieved and happy at today’s progress,” said Dr Savita Verma, principal investigator of the Covaxin clinical trial at PGIMS-Rohtak.
The subjects will now be given a second dose of the vaccine in 14 days, provided no adverse reactions are reported prior to the date. Blood samples, to check for the presence of antibodies, will also be taken from the subjects at 14 days and 28 days, officials at PGIMS confirmed. “There are two proposed doses of the final vaccine — 3ug and 6ug. These are extrapolated from data obtained from pre-trial tests on animals. We have administered the lower dose today,” Verma added.
Doctors at PGIMS explained that, at this point in the double-blind trial, it is unknown whether any of the three subjects received a placebo. “The vials we received are not marked. There is a 4:1 ratio, where for every four persons who receive the vaccine, one person gets a placebo, but as the administrator, we will not know who gets what. We may know in 14 days, depending on seroconversion,” Verma said.
