Tribune News Service
Chandigarh, August 3
The Post Graduate Institute of Medical Education and Research (PGI) is expected to start the clinical trials of the Oxford University-Astra Zeneca Covid-19 vaccine (Covishield) by August-end after recruiting volunteers.
The Drugs Controller General of India granted approval to the Serum Institute of India, Pune, for conducting the vaccine trials in the country yesterday.
The PGI is among the trial sites listed in the study, which will involve administration of the vaccine to 1,600 healthy adults across 17 trial sites.
The principal investigator of the trials, Dr Madhu Gupta, Professor, Community Medicine and School of Public Health, PGI, said, “The protocol has been finalised and will be sent to the ethics committee for clearance before starting the trials as patients’ safety is of utmost importance. We will assess the benefit and harm and get it approved from the institute.”
The protocol has been finalised and will be sent to the ethics committee for clearance before starting the trials as patients’ safety is of utmost importance. We will assess the benefit and harm and get it approved from the institute. — Dr Madhu Gupta, PGI Professor
“We will assess the safety of the trials and see whether antibodies are formed after the vaccine is administered in the body. The vaccine stimulates the virus for protection but does not cause the disease,” said Dr Gupta.
The participants will be recruited after a thorough medical screening. The inclusion criterion is that the participant must be a healthy adult above 18 years of age. Moreover, the adult must not have contracted Covid-19 in the past or no family member should have a history of coronavirus.
Dr Gupta said, “We have committed about 250 participants from the PGI. The recruitment will be done in the first month and the duration of the trials will be six months. For recruitment, we will advertise for Chandigarh-based residents to participate in the vaccine trials.”
Currently, the phase 2 and 3 clinical trials of the Oxford vaccine candidate are going on in the UK, the phase 3 clinical trials in Brazil and the phase 1 and 2 clinical trials are under way in South Africa.
As per the study design, each subject will be administered two doses four weeks apart (the first dose on day one and the second on day 29) following which the safety and immunogenicity will be assessed at predefined intervals.
Medical screening for participants
The participants will be recruited through medical screening. The inclusion criterion is that the participant must be a healthy adult. Moreover, the adult must not have contracted Covid-19 in the past and no family member should have a history of the virus.
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