Covid-19: Patna AIIMS to enroll 1,000 volunteers for Covaxin phase 3 trial
The Indian Institute of Medical Sciences (AIIMS), Patna, plans to enroll between 1,000 and 1,200 volunteers as part of the third and final phase of the multi-center human trial of Covaxin, the Covid-19 vaccine indigenously developed by Bharat Biotech.
The trial is a double-blind, randomized, placebo-controlled trial, in which half of the volunteers will be given the vaccine and half will be given a placebo that does not contain the active ingredient that affects health, partner sources said. the test.
Since the trial is double blind, vaccinated volunteers will not know whether they received the vaccine or a placebo, to rule out biases on issues related to treatment and statistical analysis.
The placebo-vaccine ratio was 1: 3 in the first phase of the trial that focused on safety. It did not occur in the second stage, but would be administered in a 1: 1 ratio in the third stage, sources said.
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“We hope to start enrolling healthy volunteers between the ages of 18 and 55 from December 2 and tentatively begin the third phase of the trial from December 5 or 6,” said Dr. CM Singh, AIIMS Superintendent, Patna, who he is also the principal investigator of the trial.
Volunteers will receive two injections of the vaccine within 28 days. Over the next 194 days, medical experts will conduct regular follow-ups.
“The follow-up sampling to verify the level of immunogenicity (amount of antibodies produced in a healthy body to fight against the SARS virus CoV-2, which causes the disease) must be carried out on days 14, 28, 42, 104 and 194” added Dr. Singh.
The third phase will exclude volunteers in the first two phases of the trial, they said. Up to 46 volunteers had enrolled here out of a total of 375 at different centers during the first phase of the trial. In the second stage, 44 volunteers enrolled in AIIMS, Patna, out of 750 across India.