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

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

Read | HP reports two more COVID-19 deaths, 83 fresh cases

Read | COVID-19 cases rise to 1.12 lakh in Bihar; recovery rate improves to 75 per cent plus

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

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

test would be conducted across 17 locations in nation. 

Read | One death, 91 fresh cases in Chandigarh; total count 2,396

Read | 1,132 new coronavirus cases in Mumbai, 46 deaths

Some of hospitals where 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 ors. 

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

" COVISHIELD( vaccine for COVID-19) shall be administered two times on day one and 29 as a 0.5 ml dose intramuscularly. 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 CTRI. 

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

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

Read | India, China expected to hold ar round of diplomatic talks on Thursday

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

In exclusion part, those, who would be having a history of COVID-19 would t be a part of same. Also, those who have acute illness shall t be a part of same. Also participants, who have a history of severe allergic reactions due to vaccination or any or components, wher being suspected or confirmed, with impaired or altered functioning of immune system shall be asked to leave. 

(With ANI Inputs)

(Im Credits:ANI)