NIMS begins subject enrollment for Phase 1 trial of COVID-19 vaccine
Category: #health  By Saipriya Iyer  Date: 2020-07-09
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NIMS begins subject enrollment for Phase 1 trial of COVID-19 vaccine

Nizam’s Institute of Medical Science (NIMS) has recently commenced the enrollment of subjects for its Phase 1 clinical trials of the COVID-19 vaccine. It is the 1st indigenous coronavirus vaccine candidate developed in India.

Following the approval of the ICMR (Indian Council of Medical Research), the company has begun to register around 30 to 60 candidates. The swab and blood samples of these candidates will be examined. After a week, the subjects who are fit for the trial will be administered with the 1st dose of the vaccine.

As per the reported statement made by Dr. K Manohar, NIMS’s Director, the healthy subjects will be screened & their swab and blood samples will be sent to the lab designated by ICMR in New Delhi. The Medicine Department will analyze the test reports and issue fitness certificates to the candidates.

In the clinical trial, the subjects will be administered with 2 doses of the vaccine, i.e. 3-microgram and 6-microgram dosage as well as a placebo. They will later be given the 2nd dose of the vaccine after 2 weeks.

After administering the vaccine, the subjects will be monitored in the ICU for 2 days, after which, they are likely to be sent home and remotely monitored via video conferencing or phone.

NIMS will conduct the 1st phase of the trial for 28 days. After the completion of this phase, ICMR and DRCI (Drug Controller General of India) will accord permission to commence the 2nd phase of the study with more subjects. Nearly 375 candidates will be registered for the Phase 1 trial across the country, with around 875 subjects for the 2nd phase.

The clinical trial is expected to start on 15th August, which is in accordance with the accepted norms to rapidly develop the COVID-19 vaccine across the globe.

The company had successfully developed the vaccine candidate, Covaxin, in partnership with NIV and ICMR. The pre-clinical vaccine study demonstrated the immune response and safety of the vaccine candidate, which helped gain CDSCO and Ministry of Health & Family Welfare approval for Phase I & II human trials.

Source credit:

https://www.businessinsider.in/india/news/hyderabad-nizams-institute-of-medical-science-begins-the-human-clinical-trial-of-covid-19-vaccine/articleshow/76833471.cms



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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