Serum Institute registers Covid vaccine trial; AIIMS Delhi one of the trial sites
The date of the first enrolment will be August 24, according to CTRIUpdated: Aug 20, 2020 11:13 IST
The Serum Institute of India (SII) has registered its phase II/III clinical trials of the Oxford-AstraZeneca coronavirus disease (Covid-19) vaccine candidate, Covishield, with the Clinical Trials Registry of India (CTRI). The trails will be conducted on 1,600 healthy participants across India.
New Delhi’s All India Institute of Medical Sciences is one of the 17 sites selected to conduct Phase II/III, observer-blind, randomized, controlled study, to check the safety and immune response of the vaccine in healthy Indian adults. The study is planned for seven months. The date of the first enrolment will be August 24, according to CTRI.
SII is the world’s largest vaccine manufacturer by the number of doses produced and sold globally. It has a manufacturing partnership with AstraZeneca to produce the Oxford-AstraZeneca vaccine.
Dr Prasad Kulkarni will be the principal investigator for SII, who will spearhead the trials at 17 hospitals across the country. The hospitals include Andhra Medical College (Visakhapatnam), JSS Academy of Higher Education and Research (Mysore), Seth G. S. Medical College and KEM Hospital (Mumbai), KEM Hospital Research Centre (Vadu), B J Medical College and Sassoon General Hospital (Pune).
KEM Hospital Research Centre’s Ethics Committee has received the mandatory approval for the trials. The approval is under process for the rest of the 16 hospitals.
Institute Ethics Committee clearance is mandatory to begin any clinical studies in India.
Covishield will be administered as a two-dose schedule on days 1 and 29 as 0.5 ml dose intramuscularly. Placebo will be administered as a two-dose schedule on days 1 and 29 as 0.5 ml dose intramuscularly.
Healthy participants, both men and women, selected for the trials are above 18.
Those, who are ineligible, include people with acute illnesses with or without fever at the time of study vaccine administration, history of laboratory-confirmed Covid-19 disease in household contact or close workplace contact, etc.