The University of Oxford is set to initiate its COVID-19 vaccine phase-II and III clinical trials in India. The Serum Institute of India has undertaken all the necessary processes as per the report by ANI.
The Jenner Institute of Oxford University has developed the COVID-19 vaccine (1).
The British-Swedish pharma company has backed the formulation of the new vaccine. They have collaborated with Serum Institute of India, Indian vaccine maker, to manufacture the COVID-19 vaccine for low and middle-income nations.
In early August, DCGI gave the nod to conduct clinical trials in India. These trials will be observer-blind, randomized, and control studies. The aim will be to determine the safety and the immunogenicity of Covishield in healthy Indian adults.
Clinical Trials to be Conducted in 17 Indian Cities
The drug markers have shortlisted 17 cities in India for the clinical trial. As per the study design, a total of 1,600 candidates will participate in the study.
The some of the cities included for the clinical trials are
- 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)
- All India Institute Of Medical Sciences (Jodhpur)
- Rajendra Memorial Research Institute of Medical Sciences (Patna)
- Institute of Community Medicine ( Madras)
- Post Graduate Institute of Medical Education & Research (PGIMER)
- Bharati Vidyapeeth Deemed University Medical College and Hospital (Pune)
- Jehangir Hospital ( Pune)
- AIIMS (Delhi)
- ICMR- Regional Medical Research Centre (Gorakhpur)
- TN Medical College & BYL Nair Hospital (Mumbai)
- Mahatma Gandhi Institute of Medical Sciences (Sewagram)
- Government Medical College (Nagpur)
400 participants of 1600 candidates to be part of the immunogenicity cohort. These candidates will be assigned randomly to a 3:1 ratio. They will either receive Covishield or Oxford/AZ-ChAdOx1 nCoV-19, respectively. The remaining participants will either receive Covishield or Placebo as per the reports of ANI.
Once the phase II trial of Covishield is completed, reports will be submitted to the Data Safety Monitoring Board. After that, the Central Drugs Standard Control Organization will initiate the procedures for the next phase of the trial as per the statement of Dr. Hemant Deshmukh, King Edward Memorial Hospital.