Serum Institute of India (SII) has initiated phase two and three clinical trials of its COVID-19 vaccine to evaluate its safety and immune response on healthy Indian adults, news agency ANI reported.
The pharmaceutical giant received approval from the Drugs Controller General of India (DCGI) earlier this month.
According to the report, a total of 1,600 participants, aged 18 and above, will be enrolled in the study, which will be conducted on 17 sites in India.
These sites include the Andhra Medical College in Visakhapatanam, Seth GS Medical College and KEM Hospital in Mumbai, BJ Medical College and Sassoon General Hospital in Pune, All India Institute of Medical Sciences (AIIMS) in Delhi, among others.
Of the total participants, according to the report, 400 will be a part of immunogenicity cohort and will be randomly assigned, in a 3:1 ratio, to receive either COVISHIELD or Oxford/AZ-ChAdOx1 nCoV-19.
The remaining participants will be assigned, again in a 3:1 ratio, to receive either COVISHIELD or the placebo, respectively.
According to the Clinical Trial Registry India, Covishield will be administered as two doses on day one and 29 as a 0.5 ml dose intramuscularly.
"Placebo will be administered as two doses on scheduled days one and 29 as 0.5 ml dose intramuscularly," it added.
A written form of consent will have to be filled by the participants and they have to reside in the study area while also complying with the study protocol requirements. Participants, according to the report, will be excluded if they have acute illness with or without fever at the time of vaccine administration.
Those with a history of laboratory-confirmed COVID-19 disease will not be enrolled for the study, according to the report. Moreover, female participants of childbearing potential are required to have a negative urine pregnancy test 24 hours prior to the vaccine administration.
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