The PGIMER on Friday invited volunteers to be a part of the Phase 2 clinical trials of the Oxford Covid-19 vaccine, COVISHIELD. A circular published by the institute, which has been approved by the ICMR as a site for conducting the vaccine’s Phase 2 and 3 clinical trials, announced that it will start the ICMR/SII-COVISHIELD study titled, ‘A phase 2/3 observer blind, randomized, controlled study to determine the safety and immunogenicity of COVISHIELD (Covid-19 Vaccine) in healthy Indian adults.’ Sponsored by Serum Institute of India and co-sponsored by ICMR, participation in the vaccine trial will be on voluntary basis. The notice said that healthy volunteers above the age of 18 years (not involved in patient care), who are interested to participate in the study, may register themselves through email or text message.
The registration form for volunteers will ask for basic information including name, age, sex, phone number, address and Email ID. The Principal Investigator for the trial at PGIMER, Dr Madhu Gupta said trials will most likely begin in the first week of September. The project staff has already been finalised by the internal committee of the institute, with all the facilities in place. 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.
The minimum age for volunteers, said Dr Gupta, is 18 years of age, and volunteers need to be healthy adults with no comorbidity, and they must not have contracted Covid-19. The volunteers will be finalised after they and their family members test negative for the disease. Those with serious illnesses, allergies to vaccines and pregnant women, among others will not be able to volunteer for the trials. There will be no upper age limit for volunteers as the vaccine creates different antibodies in varied age groups. “We already have some registrations in place and we plan to screen 350 people, out of which 250 will be recruited for the trials. We will be giving appointments for screenings, to avoid crowding and maintain social distancing,” added Dr Gupta.
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