Indian pharmaceutical giant Serum Institute of India has initiated the phase 2, 3 clinical trials to evaluate the safety and immune response of coronavirus vaccine candidate on healthy Indian adults after the pharma company got approval from Drugs Controller General of India (DCGI) earlier this month.
According to the Clinical Trial Registry India, the scientific title of the study says that phase 2/3 clinical trial will be observer-blind, randomised, controlled study to determine the safety and immunogenicity of Covishield (COVID-19 vaccine) in healthy Indian adults.
A total of 1,600 eligible participants of more than or equal to 18 years of age will be enrolled in the study, which will be conducted on 17 sites in India.
These sites 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), 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) and Government Medical College (Nagpur).
Of the total 1,600 eligible participants, 400 participants will be part of the immunogenicity cohort and will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or Oxford/AZ-ChAdOx1 nCoV-19, respectively.
The remaining 1,200 participants from safety cohort will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or Placebo, respectively.
The Clinical Trial Registry India said that the Covishield (COVID-19 vaccine) will be administered as 2 doses schedule on Day 1 and 29 as 0.5 ml dose intramuscularly.
"Oxford/AZ- ChAdOx1NcOV-19 vaccine will be administered as dose 2 schedule on Day 1 and 29 as 0.5 ml dose intramuscularly," it said.
"Placebo will be administered as 2 doses on scheduled Days 1 and 29 as 0.5 ml dose intramuscularly," it added.
The clinical study is based on two criteria -- inclusion and exclusion.
In the inclusion criteria -- healthy adults aged more than or equal to 18 years of either sex will participate in the study. A written informed consent has to be taken by the participants and they have to be a resident of the study area and willing to comply with the study protocol requirements. Healthy as determined by medical history and physical examination. Female participants of childbearing potential must have a negative urine pregnancy test 24 hours prior to the vaccine administration.
Similarly, exclusion criteria says that participants will be excluded who are having acute illness with or without fever at the time of study vaccine administration. Those having the history of laboratory-confirmed COVID-19 disease in household contact or close workplace contact will not be enrolled for the study. Participants with IgG seropositivity to SARS-Cov2 and with history or currently positive for SARS-CoV-2 by RT-PCR cannot participate.
It also says that volunteers with a history of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines and any confirmed or suspected condition with impaired/altered function of the immune system shall not participate in the study.
