KOLKATA: NICED will start phase III of the clinical trial of Covid-19 candidate
vaccine —
Covaxin — on Wednesday, NICED director Shanta Datta said on Monday, adding that they have received encouraging response from people willing to volunteer.
While urban development minister Firhad Hakim is likely to be screened to be a volunteer for the trial,
Governor Jagdeep Dhankhar has been invited for the December 2 inauguration along with some “special guests”. The Governor, who is in Darjeeling now, is scheduled to reach Kolkata by train late on Tuesday. Hakim, who is returning to Kolkata from Siliguri, said, “Like I have said before, I will be delighted to be a part of this trial in whatever way I can. If I am found eligible to be a volunteer, I will participate wholeheartedly.”
Datta said, “Those who are willing to participate in this trial are instructed to send their requests on the number +919836169622 or email at bbv152niced@gmail.com with their personal details (name, age, sex, address, contact number, email and co-morbidities, if any). According to trial protocol, a limited number of participants will be enrolled after screening. The participants will be contacted for further details over the given mobile/email. Participants’ enrollment will continue until the target number is achieved.”
In a statement on Monday, NICED said, “The final analysis of the results will be available after one year follow-up post second dose of vaccination. The phase 1 and phase II trials have shown promising results. Currently, the phase III multicentric study, including 24 centres, has been initiated across India with a plan to recruit 25,000 volunteers.” It added that
the Drug Controller General of India has selected NICED as one of the 24 sites.
The phase III study at NICED will involve 1,000 volunteers — 500 getting the actual vaccine while the rest will get placebo shots. The volunteers will get the second shot about four weeks later. The basic criteria to volunteer includes being above 18 and having been free of Covid infection during the entire pandemic.
The School of Tropical Medical (STM) is trying to roll out the phase III trial of Covid-19 candidate vaccine Covovax in the third or fourth week of December. US-based Novavax, Serum Institute of India and ICMR are sponsoring the trial at STM. The institute has been preparing itself even while it was awaiting a green signal from regulatory authorities.