Serum Institute of India to begin trial on 1600 volunteers for potential COVID-19 vaccine

The Serum Institute of India, India's pharmacy giant on Wednesday initiated phase 2 and 3 of trials for evaluating the response in terms of safety and immunity of the vaccine on healthy Indian adults, after receiving approval from the Drugs Controller General of India(DGCI). 

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According to Clinical Test Registry India(CTRI), the test which would be conducted would be "observer-blind, randomized, controlled to determine the safety among the healthy adults of the subcontinent."

The study, which would be conducted, will consist of 1,600 participants, all either being more than 18 years of age or equal to it.

The test would be conducted across 17 locations in the nation. 

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Some of the hospitals where the test would be conducted include All India Institute of Medical Sciences(AIIMS) in Delhi, Andhra Medical College in Visakhapatanam, Seth GS Medical College and King Edward Memorial(KEM) Hospital in Mumbai, Post Graduate Institute of Medical Education and Research in Chandigarh, Jehangir Hospital in Pune, Indian Council for Medical Research(ICMR) in Gorakhpur, Institue of Community Medicine in Chennai, among others. 

Of the 1,600 patients who would be selected, 400 of them would be a part of the immunity cohort and would randomly be assigned, in a 3:1 ratio to receive either COVISHIELD or Oxford/AZ-ChAdOx1NcOV-19, respectively. 

"The COVISHIELD(the vaccine for COVID-19) shall be administered two times on day one and 29 as a 0.5 ml dose intramuscularly.The Oxford/AZ-ChAdOx1NcOV-19 will be administered as dose two, scheduled on day one and 29 as 0.5 ml dose intramuscularly," said a report by the CTRI. 

The other remaining 1200 patients would be randomly assigned in a 3:1 ratio to receive either COVIDSHIELD or Placebo.

"The placebo shall be administered as two doses schedule on Day 1 and 29 as 0.5 ml dose intramuscularly," further added the report.

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The study would be based on two criteria, which would be inclusion and exclusion. In the inclusive category, adults, both males, and females, who are in the pink of their health would be participating in the same. A well-written consent of the participants would be taken. Women, who have childbearing potential, would have to give a negative urine report, about 24 hours before the testing.

In the exclusion part, those, who would be having a history of COVID-19 would not be a part of the same. Also, those who have acute illness shall not be a part of the same. Also participants, who have a history of severe allergic reactions due to vaccination or any other components, whether being suspected or confirmed, with impaired or altered functioning of the immune system shall be asked to leave. 

(With ANI Inputs)

(Image Credits:ANI)