Pune-based Serum Institute of India (SII) has initiated the phase 2 and phase 3 clinical study to evaluate the safety and immune response of its Covid-19 vaccine candidate, Covishield, across the country later this week after it got approval from Drug Controller General of India (DCGI) earlier this month for the human trials, reports ANI.
The phase 2/3 clincal trial of the SII's Covid-19 vaccine candidate, which has been developed by Oxford University and pharma company AstraZeneca and called ChAdOx1, will be observer-blind, randomised and controlled study to determine the safety and immunogenicity of the Covishield in healthy Indian adults, according to the Clinical Trial Registry India.
It should be noted that Serum Institute, which is the world's largest manufacturer of vaccines by volume, has partnered with AstraZeneca to produce Covid-19 vaccine.
For the study being conducted at 17 sites in India, a total of 1,600 volunteers of age more than or equal to 18 years will be enrolled.
The study sites include AlIMS Jodhpur, Government Medical College Nagpur, PGIMER, Andhra Medical College in Visakhapatnam, Seth G S Medical College and KEM Hospital in Mumbai, JSS Academy of Higher Education and Research (Mysore), Jehangir Hospital in Pune and ICMR - Regional Medical Research Centre in Gorakhpur among others.
Of the total 1,600 eligible participants, 400 will be part of the immunogenicity cohort while the remaining 1,200 will be part of the safety cohort.
The Covishield, according to the CTRI, will be administered as two doses schedule on day 1 and 29 as 0.5 ml dose instramuscularly.
"Placebo will be administered as 2 doses on scheduled Days 1 and 29 as 0.5 ml dose intramuscularly," the CTRI said.
Oxford-AstraZeneca’s Covid-19 vaccine candidate ChAdOx1, a chimpanzee adenovirus vaccine vector, has shown encouraging results in early human trials. The results of the phase 1/2 trial published in the scientific journal, The Lancet, showed that the vaccine induces strong immune responses against the novel Coroanavirus and shows no early safety concerns.
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