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Covaxin human clinical trials begin at AIIMS Delhi on Monday: All you need to know | India News

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NEW DELHI: The All India Institute of Medical Sciences (AIIMS) in Delhi began phase I/II of human clinical trials of the indigenously developed Covid-19 vaccine candidate ‘Covaxin’ on Monday. AIIMS Delhi is among the 12 sites which will be undertaking human trials for Covaxin.
Here is all you need to know about AIIMS trials:
* The human trial at AIIMS (Delhi) have started after Drugs Controller General of India (DCGI), India’s top drug regulator, had recently given a green signal for Covaxin human clinical trials.
* Covaxin has been developed by the Hyderabad-based Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV).
* AIIMS (Delhi) had registered a few volunteers for the trial. These volunteers will be undergoing health screening on Monday before they are administered Covaxin.
* Total 375 volunteers were listed for human clinical trials out of which AIIMS (Delhi) will be choosing only 100 participants for the first and second phase of the trials. Rest of the volunteers will undergo trials at a different site.
* ICMR has notified 12 sites where the trial for Covaxin will be taking place.
* On July 17, human trials of Covaxin began at Post-Graduate Institute (PGI) of Medical Sciences in Rohtak on Friday where three volunteers were administered Covaxin.
* Trials have started at AIIMS, Patna and few other places as well.
* Another facility which will be starting the process of human trials for Covaxin is Redkar Hospital in North Goa’s Pernem taluka. The North Goa-based private hospital is also amongst the 12 listed facilities.
* Redkar Hospital will be selecting ten volunteers from Goa and instead of randomizing the facility will select volunteers on basis of eligibility. The reports for prospective volunteers were first sent to Delhi to ascertain their eligibility following which those clear the selection criterion will be administered Covaxin.
How to participate in AIIMS trial
* Any healthy individual who wishes to participate in the trial can send in an email on—[email protected] —or send an SMS or call on 7428847499.
* Volunteers should have no comorbid conditions and should not have a history of Covid19.
* Volunteers between 18-55 years would be eligible to participate in the randomised, double-blind, placebo-controlled clinical trial.
Two indigenous vaccine candidates in human trial phase
* Besides Covaxin, DCGI has also permitted pharma giant Zydus Cadila to conduct phase I/II clinical trials on humans for Covid -19 vaccine.
* Both Covaxin and Zydus Cadila’s vaccine candidate got the approval for human trials after successful toxicity studies in rats, mice and rabbits. These are only two indigenous vaccine candidates that have reached the human trial phase in India.
(With inputs from agencies)

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