Home / News / India /  Human trials of Covid-19 vaccine, Covaxin to start at Bhubaneswar from 22 July

Human clinical trials of the India's indigenously developed coronavirus vaccine is set to begin from tomorrow, 22 July, at a Bhubaneswar-based institute. It is one of the 12 centres selected by the ICMR for conducting phase one and two of the clinical trials. The human trials of BBV152 COVID Vaccine or Covaxin will begin on Wednesday in a special laboratory set up at the Institute of Medical Sciences and SUM (IMS & SUM) Hospital, in accordance with the protocols laid down by the Drugs Controller General of India (DCGI), the official at the facility said.

The special laboratory -- Preventive and Therapeutic Clinical Trial Unit (PTCTU) -- was inaugurated at the institute on Monday by its dean Gangadhar Sahoo. "All necessary arrangements have been made for conducting the human trials. We expect to start from Wednesday," Dr E Venkat Rao, the principal investigator of the trial process and professor of community medicine at the hospital, told PTI.

The human trials of BBV152 COVID Vaccine or Covaxin will begin on Wednesday. Here is all you need to know:

1) Healthy volunteers aged between 18 and 55 years having no comorbid conditions or COVID-19 history would be eligible to participate in the clinical trials.

2) The trial centre will go through the profiles and conduct a thorough screening to choose the suitable ones.

3) The prospective volunteers will be screened and their health conditions will be thoroughly evaluated before administering them the vaccine.

4) The trial centre will conduct physical and laboratory tests, in accordance with the ICMR protocol, and counsel the volunteers who meet all criteria about the possible risks and obtain their consent before initiating the process.

5) All four phases of the clinical trials involving human subjects would be conducted at the centre.

6) close to 30-40 candidates will be chosen for the first phase of the human trials which will commence from June 22.

7) The selected volunteers who have been administered the vaccine will have to stay in the trial centre for around two hours for observation to rule out any possible side-effect and complication.

8) They will be given two doses within a gap of 14 days.

9) The candidates will be monitored and they will be in constant touch with the trial centres. The antibody level in their blood after taking the vaccination if it found adequate, then they can go for the second and then for the third phase.

10) Healthy volunteers who wish to participate in these clinical trials can contact the institution, to register online through their website- http://ptctu.soa.ac.in/ .They can also contact 91 89172 11214 through WhatsApp.

India's indigenously developed coronavirus vaccine, Covaxin

This is the first indigenous vaccine developed by India against COVID-19 and is derived from a strain of SARS- CoV-2 isolated by ICMR-National Institute of Virology, Pune.

ICMR and Bharat Biotech are jointly working for the preclinical as well as clinical development of this vaccine. It has already received the approval for phase one and two by the DCGI.

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