On Friday, PGIMER, Chandigarh, issued a circular inviting healthy volunteers for Phase-2 clinical trials of Oxford Covid vaccine, Covishield. The human trial is aimed to test the safety and immunogenicity of the vaccine.
Dr Madhu Gupta, Principal Investigator of the trails giving more information on the ICMR/SII-Covi Shield said, the study is 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’. It has been sponsored by Serum Institute of India Pvt Ltd and co-sponsored by Indian Council of Medical Research.
Eligibility Criteria for participants:
• Voluntary participation
• Must be above 18 years of age
• Participant must not have history of COVID-19 contraction or involved in patient care.
Volunteers will be finalised once they and their family members test negative for COVID.
Following are ineligible to participate:
• Those with acute illnesses with or without fever at the time of study
• 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
• Pregnant women.
All those interested are required to send the registration form either by email on firstname.lastname@example.org or via a text message on +91 7696148362. The registration form is available on the institute’s website.
250 to be recruited
The institute is planning to screen around 350 people & out of those, 250 individuals will be recruited for the trials, said Dr Gupta.
In order to avoid crowding and maintain social distancing, appointments will be given to individuals for screening.
PGIMER has been chosen amongst the 17 sites in the country to conduct second and third phases of human trials of Covishield.