Phase-3 Trial Of Covaxin To Begin In AIIMS-P From Dec 4
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Covaxin is one of the first indigenous vaccines developed against Covid-19 and is derived from a strain of SARS-CoV-2 isolated by the Indian Council of Medical Research (ICMR)-Delhi and the National Institute of Virology (NIV), Pune. The final phase of the clinical trial is all set to begin at AIIMS-Patna from December 4.

They aim to administer 1000 people in the final trial, so far 300 volunteers have enrolled. Healthy individuals above 18 years of age will be selected through a screening process and medical examination.

A dose of 0.5 ml via intramuscular injection would be given on day zero and day 28. After receiving the dose, the volunteers would be in observation for half-an-hour and will be monitored for the next few days over the telephone, said Dr CM Singh, AIIMS-P superintendent and principal investigator of the vaccine trial.

The trial protocol requires follow-ups on day 28, 42, 104 and 194. The follow-up sampling will be done to check the level of immunogenicity meaning the amount of antibody produced in a healthy body to fight against the SARS CoV-2 virus, which causes the disease.

Source:
https://health.economictimes.indiatimes.com/news/pharma/aiims-p-to-begin-phase-3-vaccine-trial-from-dec-4/79539924
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