2nd phase of Covid vaccine human trial begins in Tamil Nadu

 2nd phase of Covid vaccine human trial begins in Tamil Nadu

TIMES NEWS NETWORK

Chennai:29.09.2020

The phase-2 human clinical trials of Covishield, developed by Oxford University, commenced in the state on Monday even as the health department invited volunteers to enroll and participate in the trials. The safety and immunogenicity or the immune response of the vaccine candidate will be studied upon administering shots to healthy volunteers. Two centres in the city are among the17siteschosen for the trials initiated in the country by Serum Institute of India, which has an agreement with AstraZeneca that has collaborated with Oxford University.

A state health department official confirmed that volunteers were given shots of the vaccine candidate on Monday. However, officials did not reveal details on the number of volunteers who were administered the shots. The state health department started calling for volunteers on September 9 through social media.

Earlier Dr T S Selvavinayagam, director of public health and principal investigator of the project, had said, “This phase requires 110 to 150 volunteers. Screening of volunteers to see if they are fit enough for the trials is going on.” In Tamil Nadu, trials will take place at Rajiv Gandhi Government General Hospital and at Sri Ramachandra Institute of Higher Education and Research, Porur.

According to the Clinical Trials Registry India, 1,600 volunteers of more than or equal to 18 years will be enrolled in the study across17 sites in the country. Of them, 400 participants will be part of the immunogenicity cohort. They will be randomly assigned on a 3:1 ratio to receive either Covishield or Oxford/AZ-ChAdOx1 nCoV-19. The rest of the 1,200 volunteers from the safety cohort, also randomly assigned in a 3:1 ratio, will receive either Covishield or placebo. Covishield was made from ChAdOx1 virus, a weakened version of a common cold virus that causes infections in chimpanzees that has been genetically changed. Genetic material has been added which is used to make proteins from the SARS-CoV-2 virus called spike glycoprotein. By vaccinating, researchers hope the body will recognise and develop an immune response to the spike protein that will help stop the coronavirus from entering human cells and prevent infection.