Covaxin’s clinical trials see high interest from volunteers
- In the first phase of the clinical trial, 375 participants, or volunteers, will be admitted in 12 sites
- There is more interest due to the seriousness of the situation created by the pandemic,
India’s first human trial for a covid-19 vaccine candidate, Covaxin, which is being jointly developed by Bharat Biotech International Ltd and the Indian Council of Medical Research (ICMR), has seen high interest from potential participants.
“We are expecting approval from the ethics committee in a day or two. Then there will be site inspections. After that, the enrolment process will start. But our hospital control room is already getting calls for participation,” said a clinical investigator for the trial, requesting anonymity.
In the first phase of the clinical trial, 375 participants, or volunteers, will be admitted in 12 sites. However, initially each centre will have just five participants, who will be administered a low dose to test the drug’s safety, a second investigator said.
“We will conduct a test to check human safety of the vaccine candidate using low dosage and, once it is proven, there will be a lot more interest for the vaccine,” the person said.
Past experience has shown that testing organizations typically had to do extensive outreach to enrol volunteers for human trials. However, industry watchers said things were distinctly different this time, and this can be attributed to the seriousness of the situation created by the pandemic.
“Everyone is aware of the disease, and there is focus on the trial. Probably that is a reason for the interest,” a third investigator said.
Covaxin is being developed by Bharat Biotech and ICMR’s National Institute of Virology in Pune. The clinical trials registry for the phase 1 and 2 studies will have 1,125 participants. Around 375 volunteers will be needed in the phase 1 study across 12 sites, and 750 in phase 2.
However, till Tuesday, only half of the 12 sites that were selected for the clinical trial had received approval from the respective ethics committees.
This is in contrast to ICMR director general Balram Bhargava’s letter last week asking Bharat Biotech and the investigators to start recruitment by 7 July. Three sites said they were expecting to get an approval from ethics committee this week.
According to the ethical guidelines for conducting human trials, volunteers should participate in the clinical study only after giving informed consent, with no financial benefit from the sponsor. If there was a need for travel, the participant will be reimbursed for the commute, and any cost for controlling the side effects will also be borne by the sponsor, one of the investigators said.Subscribe to newsletters
Source : Live mint
2 min read. 07 Jul 2020
The much-awaited trial process of India’s first possible vaccine against COVID-19, Covaxin, has started on Tuesday at the Nizam’s Institute of Medical Sciences (NIMS), a top official confirmed. Developed by Bharat Biotech, the Covaxin will be tested on over 1,100 people in two phases. The company had a plan to enroll 375 participants to test COVID-19 vaccine candidate this month.
Hyderabad’s Nizam’s Institute of Medical Sciences was one of the trial sites that received the Indian Council of Medical Research (ICMR)’s letter. “We will select healthy individuals and draw blood and send the blood samples to designated labs in New Delhi. They will give the green signal. Then the medicine people will examine and the first shot of the vaccine will be given due observation,” NIMS director Dr K Manohar told PTI.
The ICMR has selected 12 institutes to conduct these trials, including AIIMS in Delhi and Patna. The apex medical body asked their principal investigators to ensure the enrolment process is initiated no later than by July 7.
“Everything will be sent to ICMR, where data is analysed. We have already started the screening of individuals. We will first take audio visual consent of the individual,” the doctor added. For clinical human trial in Hyderabad’s Nizams Institute of Medical Sciences, at least 30 people are required, said the medical officer.
Last week, the Drug Controller General of India granted permission to initiate Phase I & II human clinical trials for COVID-19 vaccine Covaxin. The drug regulator’s nod to conduct human trials for Indian COVID-19 vaccine candidates COVAXIN and ZyCov-D marks the “beginning of the end” of the corona virus pandemic, says the Ministry of Science and Technology.
The announcement of Covaxin by Bharat Biotech and ZyCov-D by Zydus Cadila was the “silver line in the dark clouds”, the article by T V Venkateswaran, who is a scientist with Vigyan Prasar, said.
India’s second possible vaccine against COVID-19, ZyCoV-D, is all set to start its human trial this month, the company said. The trials will be conducted on 1,000 volunteers across multiple sites in the country. Zydus Cadila group chairman Pankaj Patel said it would take three months to finish the trials.
Source : Live mint
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