Bhubaneswar: The third-phase human trial ofhas begun at IMS & SUM Hospital here.
The vaccine was administered to two recruits at the Preventive and Therapeutic Clinical Trial Unit (PTCTU) at the hospital, Dr E Venkata Rao, Principal Investigator in Covaxin human trial, said.
He further said the vaccine’s first phase trial primarily looked at its safety aspect for human use without any significant side effect, while Phase 2 measured the antibody level in the human blood and checked whether it was sufficient to protect the person from the infection. The third phase trial would check the efficacy of the vaccine.
“In fact, phase three of the trial is crucial and tedious as we have to wait till the development of the disease which was dependent on the frequency of the disease in the population. So we need to recruit a large number of subjects and more than 25,000 volunteers were being recruited for the trial across the country,” Prof Rao said.
In phase three, two doses would be administered to each volunteer 28 days apart but the follow-up period would extend to 12 months to look at its long term and side effects, he said.
Prof. Rao said that Covaxin was an inactivated whole-cell virion without the ability to produce the disease but helped in developing antibodies against the infection. These are time-tested vaccines while the others being developed were mRNA vaccines, new to the human population, which send a signal into the human cell for the production of antibodies against the disease.
While recruiting volunteers for the phase three trial, the restriction of being
a healthy volunteer was not mandatory. Anyone with diabetes or hypertension or
with any other disease could participate in the trial provided the disease was
under control in them with medication, he said.
Volunteers desirous of participating in the trial could register on-line on the
portal http://ptctu.soa.ac.in or can send a message through WhatsApp with their
name, age, gender and the place of residence to 7849021450, he added
The institute is one of the 21 medical facilities selected across the country for the efficacy study. It is the only institute in Odisha, which has been picked for this purpose.