India / NIMS Hyd to conduct phase-I clinical trials for COVAXIN: Official

HYDERABAD:  The Nizam’s Institute of Medical Sciences (NIMS) in Hyderabad has been selected as one of the six centres across country where phase-I clinical trials for Covaxin, the vaccine against Covid-19 developed by Bharat Biotech, would be conducted, NIMS Director Dr K Manohar said on Saturday. 

Speaking to the media, Dr Manohar said many people have already sent e-mails and made phone calls expressing interest to participate in the clinical trial.

Around 60 subjects would participate in the trials.

A meeting of the Institutional Ethics Committee was convened on Saturday in this regard.

Once the approval is accorded, NIMS would start screening healthy subjects for the clinical trial, from July 7.

“As part of the screening, blood and swab samples will be collected from the subjects and sent to ICMR in New Delhi for testing in designated labs,” he said. After the testing, the reports would be uploaded by ICMR, which would be analysed by the department of medicine at NIMS and persons satisfying all criteria would be issued fitness certificates. 

Subjects to be divided into 3 groups

Following this, the subjects would be divided in three groups and administered three types of vaccines — three micrograms, six micrograms and placebo.

The same vaccine would be administered to the persons after 14 days. 

After the first two days of administering the vaccine, the subjects would be monitored for two days in the ICCU at Nizam’s Institute Of Medical Sciences (NIMS) by a team of doctors, after which they would be sent home and monitored over video conference and phone. 

The phase-I clinical trial would go on for 28 days, after which ICMR and DGCI would accord permission for phase-II, which includes more subjects.

Phase-1 would have around 375 subjects across the country and phase-II, 875.