The Post Graduate Institute of Medical Education and Research (PGIMER) was approved by the ICMR as a site for conducting the concurrent Phase 2 and Phase 3 clinical trial of the Oxford Covid-19 vaccine in the first week of August.
Now, the stage is finally set for the Phase 2 trial to begin, as the ethics committee of PGIMER has approved and signed the final proposal and agreement for the trial, with the project staff also having been finalised by the internal committee.
The team of the project staff will include a study physician, clinical researchers, lab technicians, staff nurses, data operators, with every minute detail of the clinical trial being documented.
“It is very prestigious that the vaccine will undergo trials at PGIMER, one of the 17 approved sites in India. I am very proud of my institute and the support of our director and doctors, with all the facilities and safety protocols for trials in place,” says Dr Madhu Gupta of the Department of Community Medicine, the Principal Investigator for the trial at PGIMER.
The Oxford Covid-19 vaccine has been developed in association with the firm AstraZeneca and in India, the vaccine will be marketed by Pune-based Serum Institute as COVISHEILD.
The results of the Phase 1 trials in the UK have been positive, with the Oxford Covid-19 vaccine not presenting any adverse side-effects.
“The Phase 2 of the trials at PGIMER will focus on the safety aspects of the vaccine, and to see if the new vaccine is as good at the Oxford Covid-19 vaccine,” says Dr Gupta, adding that there will be 1,600 participants in centres across the country.
The PGIMER will soon publish advertisements in English, Hindi and Punjabi newspapers, on its website and other social media, inviting people to join as volunteers for the Phase 2 clinical trials.
Anyone above the age of 18 can volunteer for the trial (no upper age), provided they do not have any disease or are on medication.
The volunteers will sign a consent form, after understanding and reading a detailed information sheet which will include the protocols of the trial, sampling details, time frame etc. The study physician will undertake detailed medical examinations of the volunteers and an RT-PCR and antibody test will be done to rule out Covid-19.
“The test has to be negative for us to proceed further and we will give a randomised placebo or vaccine and will ask the volunteer to wait for half an hour to observe if there are any side effects and then the person can go home and resume normal activity. We hope to screen 350 people, out of which 250 will be recruited. We will be giving appointments to people and our target is not to screen more than 15-20 people daily, for we want to maintain social distancing and avoid any crowding. We hope to start the screening process by August 28. I think the process will take a month, and we would prefer to recruit volunteers from the Tricity as we will need to follow up on their health etc,” says Dr Gupta.
The travel cost will be reimbursed to volunteers and if at some stage of the trial they are tested positive for Covid-19 due to exposure from an infected person or family member, their treatment will be done free of cost.
As two doses have to be administered, the volunteers will be called for the second dose a month later and then for the next six months, they will be observed for any side effects. The trial is initially focused at seeing how safe the vaccine is in a larger pool of people, and checking for antibody production.
As for Phase 3 of the trial, Dr Gupta says that it will be a new process of selection of sites and that will focus on the study of antibody efficacy and disease prevention.
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