2nd phase of Covaxin trial to start at AIIMS-Patna today

PATNA: After the successful completion of the first phase of human trial of Covaxin, a proposed Covid vaccine, on 44 volunteers, AIIMS-Patna is now set to start the second phase of the trial from Wednesday (September 9).
The human trial of the first indigenous BBV152 vaccine in the country, jointly developed by the National Institute of Virology-Pune and Hyderabad-based Bharat Biotech International Limited in collaboration with ICMR, had commenced at AIIMS-Patna on July 15.
AIIMS-P officials said all necessary preparations have been made to carry out the second phase of trial from Wednesday.
AIIMS-P superintendent Dr C M Singh said 31 volunteers approached the hospital on Monday for the second phase of trial. “The medical examination and screening of all 31 volunteers were done on September 7,” he added.
Dr Singh said clinical trial on healthy and physically fit volunteers would start from Wednesday. “Two doses of the vaccine would be administered to each volunteer after they are selected through a screening process and medical examination. The first dose will be given on zero day and the second on day 28. The trial protocol requires follow-ups on days 28, 42, 104 and 194,” he said.
Dr Singh added, “We are only selecting healthy people (never infected with Covid-19) between 12 and 65 years of age for the second phase of trial. In the first phase, people in the age group of 18 to 50 years had been invited. Those keen to participate in the trial can contact on 9471408832. The enrolment process will continue for a week.”
Altogether 750 volunteers will participate in the phase II of the vaccine trial at 12 selected health facilities in the country, including 50 at AIIMS-Patna.
Dr Singh said while the first phase of trial focused on safety, the second phase would take into account efficacy in terms of level of antibodies developed and immune response in the body. “The results of the first phase of trial were encouraging and no volunteer complained of side effects. Altogether 44 people had received two shots of vaccine in the first phase and 15 of them have completed 42 days of trial,” Dr Singh said.