Bhubaneswar: Preparations are underway at a hospital here for the commencement of the second phase of human clinical trial of ‘Covaxin’. It should be stated that ‘Covaxin’ is, India’s indigenous COVID-19 vaccine, officials said.
“The Phase I of the trial is still continuing as we are planning for the start of the Phase II trial shortly,” said Dr E Venkata Rao. He is the principal investigator of the trial being conducted at the Institute of Medical Sciences and SUM Hospital.
“The blood samples have been collected from the volunteers who received the vaccine in the first phase. It was done to ascertain how effective the vaccine was in terms of the level of antibodies developed,” Dr Rao said. He added that there had been ‘no side effects’ in the first phase trial of the vaccine.
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The IMS and SUM Hospital is one of the 12 medical centres in India chosen by the Indian Council for Medical Research (ICMR) for conducting human trials. The ‘Covaxin’ vaccine has been developed by Hyderabad-based Bharat Biotech.
“Two doses of the vaccine were administered to each volunteer after they were selected through a screening process conducted. The screening process was conducted over a period of three to seven days prior to vaccination. The first dose was administered on ‘Day Zero’ while the blood sample was collected. The second dose was given on ‘Day 14’ and the blood sample was also collected,” Dr Rao said.
“Blood samples of the volunteers will also be collected on day 28, 42, 104, 194 for estimating the duration of protection subsequently,” Dr Rao added.
Dr Rao said there was a lot of enthusiasm among people to be part of the second phase of the human trial. Those who wish to be part of this trial could contact the centre at http://ptctu.soa.ac.in, he said.
