The Post Graduate Institute of Medical Education and Research (PGIMER) in Chandigarh will be beginning the Phase II trial of oxford Covid-19 vaccine candidate — Covishield from the first week of September.
The premier institute has received approval from its internal ethical committee and is awaiting the signing of the tripartite agreement between the Indian Council of Medical Research (ICMR) and Serum Institute of India (SII) within the next two days, Madhu Gupta, principal investigator appointee of the vaccine-trial, told IANS.
Dr Gupta said that the signing of the agreement would be followed by a site inspection and hands-on training to a 16-member staff selected to conduct the trial by Clinical Research Organisation (CRO), which is expected by September 2.
“The staff conducting the trial includes nine investigators who are faculty members of different departments like general medicine, microbiology, pathology, and rest are statistical assistants,” Dr Gupta said.
The institute will conduct the phase II trial on more than 250 candidates. The advertisement for volunteering in the trial would be released after the agreement is signed.
Gupta said that at least 350 volunteers would have to be screened to get the desired number of volunteers. “Our commitment is 253 candidates, and to get that figure, we would at least have to screen 350 volunteers,” she added.
The doctors say that they are expecting volunteers from Chandigarh itself so they can be called quickly whenever the institute requires them for follow up.
Gupta informed that the vaccine would be administered in two doses in 4 weeks. A gap of 28 days would be maintained between the doses.
“0.5 ml of each dose would be given to the candidates first. It would be repeated after 28 days, and then the candidates would be observed for further two to four weeks,” she added.
The volunteers would have to pass specific criteria before enrollment for the trial.
The prerequisites for the candidates’ eligibility include a minimum age of 18 years, no underlying medical condition and they should not have contracted Covid-19 already. Besides, the family members of the candidates should also be Covid negative, Gupta listed.
She also said that the candidates would undergo the test and would only be recruited after testing negative for Covid-19.
While the institute has put a bar on the lower age limit for eligibility, the upper age limit has been kept open. “We have kept open the upper age limit to study heterogeneity of the vaccine. It is observed that the vaccine enables the creation of varied antibodies depending on age. We would also include this factor in our study,” Dr Gupta told.
The age limit is bracketed in other vaccine trials of Covid-19.In clinical trials of COVAXIN, a Covid-19 vaccine candidate by ICMR and Bharat Biotech, A test subject needs to be between the ages of 12 and 65.
Any of the following conditions would render volunteers ineligible for the trial – acute illnesses with or without fever at the time of the study, confirmed cases of Covid-19 in household contacts or at workplace contacts, seropositivity (presence of antibodies) to Sars-Cov-2, history of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines.
Besides, a confirmed or suspected condition of malfunctioning immune system and pregnant women are also barred from volunteering.
The SII is conducting the Phase 2/3 clinical trials for the adenovirus-based Covid-19 vaccine developed jointly by AstraZeneca and the University of Oxford. PGIMER is among the 17 sites across the country to participate in the second and third phases of this vaccine’s human clinical trials.
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