NEW DELHI :
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.