Chandigarh: The Indian Council of Medical Research (ICMR) approved the Post Graduate Institute of Medical Education and Research (PGIMER) as a site for Phase 2 and Phase 3 clinical trial of the Oxford COVID-19 vaccine in early August.

The PGIME Rethics committee has now approved and signed the final proposal and agreement for the trial and the Phase 2 trial will soon begin. The project staff has also been finalized, which will include a study physician, clinical researchers, lab technicians, staff nurses, data operators, and every minuscule detail of the clinical trial will be archived.

Dr Madhu Gupta of the Department of Community Medicine is the Principal Investigator for the trial at PGIMER.

The Oxford vaccine has been developed in association with AstraZeneca. The vaccine will be marketed in India by Serum Institute under the name ‘COVISHEILD’. The Phase 1 trial results in the UK have been positive, with the Oxford vaccine not showing any adverse side-effects.

According to Dr Gupta, the Phase 2 trials at PGIMER will address vaccine safety. There will be 1,600 participants in centers across the country. PGIMER will soon publish advertisements in newspapers, on its website and other social media, to invite people to volunteer for the Phase 2 clinical trials.

Anyone above the age of 18 can volunteer for the trial, given that they do not have any disease or are on medication.

The volunteers will be required to sign a consent form, after understanding and reading an information sheet detailing the trial protocols, sampling details, duration, etc. Volunteers will undergo detailed medical examinations and an RT-PCR and antibody test to rule out COVID-19.

A placebo or vaccine will be given in a randomized manner and the volunteer will have to wait for half an hour for the team to see if there are any side effects and then the person will be allowed to go home and resume normal activity. Dr Gupta said that they expect to screen 350 people, out of which 250 will be recruited. The team aims to screen over 15-20 people every day, while trying to maintain social distancing and avoiding any crowding. The screening process is expected to begin by August 28.

The travel cost will be reimbursed to volunteers and if, during the trial, any of the volunteer is tested positive for COVID-19, they will be treated free of cost.

The trial will involve the administration of two doses. Therefore, the volunteers will be called for the second dose a month later, followed by observation for the next six months, to look for any side effects. The trial focuseson evaluating the vaccine safety in a larger pool of people, and looking for antibody production.

For Phase 3 of the trial, it will be a new process of selection of sites and will focus on the study of antibody efficacy and disease prevention, said Dr Gupta… (The Indian Express)

Source: The Indian Express