Oxford Covid-19 vaccine final trials to be held in 17 Indian hospitals
Phase 2 and phase 3 clinical trials of the Covid-19 vaccine developed by Oxford University will be held in 17 Indian hospitals with 1,600 candidates taking part in the study.
Indian pharmaceutical major Serum Institute of India has commenced final trials of the Covid-19 vaccine developed by Oxford University in several Indian hospitals including King Edward Memorial Hospital Parel, and BYL Nair Hospitals, Mumbai Central — which have received approval from Indian Council for Medical Research ICMR to start the trial.
Drugs Controller General of India has given the green light for the start of conducting advanced trials of the vaccine in India, "Phase 2/3 clinical trial will be observer-blind, randomized, controlled study to determine the safety and immunogenicity of Covishield (Covid-19 vaccine) in healthy Indian adults," according to the study design.
1,600 volunteers taking part in vaccine trial
17 Indian sites have been selected to be part of these trials, while 1,600 candidates are expected to participate.
400 participants will be picked for the immunogenicity cohort and will be randomly assigned in a 3:1 ratio to administer either the vaccine, Oxford AZD1222 nCoV-19 (previously called ChAdOx1), or placebo. The other 1,200 candidates will make up the safety cohort and will also be randomly assigned in a 3:1 ratio to receive either the vaccine or a placebo.
Over the period of 4 weeks, candidates will receive 2 doses, with the first dose given on the first day of the trial while the second one will be received on day 29.
“After the completion of the phase II trial, reports will be submitted to the Data Safety Monitoring Board, then to the Central Drugs Standard Control Organization for stage 3 of the trial," Dr. Hemant Deshmukh, King Edward Memorial Hospital said.
Brihanmumbai Municipal Corporation (BMC) is currently looking for candidates to participate in the trial after King Edward Memorial Hospital Parel, and BYL Nair Hospitals, Mumbai Central received approval from ICMR to commence the trial.