Want to volunteer for Covid-19 vaccine trials? Here's what you need to know

The phase-I human clinical trial of India's first indigenously-developed coronavirus vaccine, COVAXIN, from Telangana-based Bharat Biotech began on Friday at the AIIMS in Delhi with the first dose of the injection given to a man, who is in his 30s.

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As various pharmaceutical companies and governments begin testing Covid-19 vaccines across many countries, one may wonder about who gets to be part of these trials and how to volunteer to be part of them.

Here's all you need to know about these trials and how you can be a subject:

What is the vaccine being tested? What stage of development/trials is it at right now?

Bharat Biotech’s Covid-19 vaccine COVAXIN is being put through a randomised, double-blind, parallel group, control trial. The BBV152 vaccine from the Hyderabad-based company is being tested at multiple centres for its safety, reactogenicity, tolerability and immunogenicity of an inactivated strain of the SARS-CoV-2 virus in healthy volunteers. In other words, the vaccine is being tested for any adverse reactions on volunteers and to test whether it is effective in producing an immune response to the novel coronavirus.

Also Read: Coronavirus India update: State-wise total number of confirmed cases

How does one human clinical trial phase differ from the next?

According to a vaccine registration document, the estimated duration of the trial is expected to be one year and three months with a sample size of 1,125 trial subjects. In phase 1 of human trials, the vaccine will be tested on 375 people to see if it evokes any adverse reactions within specific time periods in the volunteers. In phase 2, the vaccine will be tested on 750 volunteers to see if it can produce antibodies for SARS-CoV-2 and the efficacy of the vaccine. Phase 1 can last anywhere between a week and three weeks. Phase 2, however, takes about 194 days. Phase 3 of the trial depends on the results from the second phase.

Can people volunteer to become trial subjects for the Covid-19 vaccine? If so, how do they do that?

Most testing sites allow for potential trial subjects to volunteer to test COVAXIN. If you are interested in participating in Bharat Biotech’s COVAXIN trials, you can contact the testing sites by phone or email.

Where is COVAXIN being tested?

The Indian Council of Medical Research has allowed COVAXIN to be trialled at 12 centres across India. These centres are:

1. AIIMS, Patna
2. AIIMS, New Delhi
3. Gillurkar Multispeciality Hospital, Nagpur
4. Institute of Medical Sciences and SUM Hospital, Bhubaneswar
5. Jeevan Rekha Hospital, Belagavi
6. King George Hospital, Visakhapatnam
7. Nizam’s Institute of Medical Sciences, Hyderabad
8. PGIMS, Rohtak
9. Prakhar Hospital, Kanpur
10. Rana Hospital and Trauma Centre, Gorakhpur
11. Redkar Hospital and Research Centre, Goa
12. SRM Hospital and Research Centre, Chennai

If you want to participate in the trial at AIIMS New Delhi, you can send an email to [e-mail] or send an SMS or call 7428847499.

What is the eligibility criteria to be a trial subject?

1. A test subject needs to be between the ages of 12 and 65, with good general health, no history of Covid-19 and normal vital signs, which would be determined by investigators at various test sites.

2. If you are female with child-bearing potential, then the willingness to use effective contraception or abstinence to avoid pregnancy during the study period is a must from the time of enrolling in the study till four weeks after the last vaccine dose.

3. You would also have to agree to remain in the study area, provide informed consent, allow storage and future use of biological samples for research, and not participate in any other clinical trial during the study period.

If you are unsure of your eligibility for the vaccine trials, please contact the trial investigators at your preferred test site.