Pune: The Phase II human clinical trial of the Oxford COVID-19 vaccine candidate began at a medical college and hospital in Pune on Wednesday. The vaccine is being manufactured by the Pune-based Serum Institute of India (SII).
Two male volunteers were administered with the vaccine at Bharti Vidyapeeth’s Medical College and Hospital, a senior office-bearer of the hospital said.
The trial began around 1 pm, he informed.
“Doctors at the hospital administered the first shot of the ‘Covishield’ vaccine to a 32-year-old man after his reports of COVID-19 and antibodies tests came out negative,” Dr Sanjay Lalwani, Medical Director of Bharti Vidyapeeth’s Medical College, Hospital and Research Centre said.
Another 48-year-old male volunteer was also given the vaccine, he added.
Five volunteers had enrolled themselves for the trial after the doses were received from the SII on Tuesday, the doctor added.
“The COVID-19 and antibodies tests were conducted on all the five volunteers. Of them, the reports of three volunteers’ antibodies test came out positive. So they became ineligible for the trial,” Dr. Lalwani said.
“The two other volunteers, who were administered the vaccines are being monitored,” he said.
According to Dr. Lalwani, in all, 25 candidates will be given the vaccine in the next seven days.
Dr. Lalwani also said that the vaccine dose will be repeated on both the volunteers after one month.
“Thereafter, the volunteers who have been given the dose of the (potential) vaccine will be observed for any reaction to the vaccine and also for the generation of antibodies against coronavirus,” he said.
The phase-2 trial will be conducted on 100 volunteers at some sites across the country, he said.
“After ensuring that there are no safety concerns in these 100 trials, 1,500 people will be administered the (potential) vaccine across the country in the next phase and generation of antibodies will be observed,” Dr. Lalwani said, adding that if results are positive, the vaccine is likely to be made available.
According to the Bharti Vidyapeeth’s Medical College and Hospital, a total of 350 volunteers will be administered the potential vaccine.
SII, the world’s largest vaccine maker has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute of Oxford University in collaboration with British-Swedish pharma company AstraZeneca.