PGI starts enrolling volunteers for Oxford Covid vaccine trials
Post Graduate Institute of Medical Education and Research (PGIMER) on Friday put out an advertisement for enrolment of healthy individuals for Oxford Covid-19 vaccine trials.
The principal investigator for the trials, Dr Madhu Gupta, in a circular, said, “We are going to start the ICMR/SII-Covi Shield study titled: A phase 2/3 observer-blind, randomised, controlled study to determine the safety and immunogenicity of Covishield (Covid-19 vaccine) in healthy Indian adults’, sponsored by Serum Institute of India Pvt Ltd and co-sponsored by Indian Council of Medical Research.”
She added that participation in this vaccine trial is purely on a voluntary basis. All healthy volunteers above the age of 18 (not involved in patient care), who are interested in participating in the study, are requested to send a registration form by email or send a text messages at: email@example.com and +917696148362. The registration form will be made available on the website.
Another important eligibility criterion is that the volunteers should not have contracted Covid-19 so far.
Those who are not eligible include people with acute illnesses with or without fever at the time of study; those having a history of laboratory-confirmed Covid-19 disease in household contacts or close workplace contacts; seropositivity (antibodies) to Sars-Cov-2; history of or currently positive for Sars-Cov-2 confirmed by real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) test; history of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines; any confirmed or suspected condition with impaired/altered function of immune system; and pregnant women.
PGIMER director Professor Jagat Ram said they are expecting the participation of around 250 individuals.
The institute will assess immunogenicity along with the safety of the vaccine. PGIMER is among the 17 sites across the country to participate in the second and third phases of human clinical trials of Covishield.