Human clinical trials of the country's indigenously developed COVID-19 vaccine is set to begin this week at a Bhubaneswar-based institute -- one of the 12 centres selected by the ICMR for conducting phase one and two of the process, a senior official said.
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 here.
Describing the new PTCTU as the first such "dedicated human trial unit" in Odisha, Rao said it would facilitate clinical research in future. Some people have already volunteered to participate in the trial, he said.
Several research organisations from across the country and outside have been eagerly waiting for such a unit in this part of the country to generate evidence in clinical research, based on factors such as local population, Rao said.
Equipped with all modern amenities, the PTCTU would focus on clinical trials involving preventive and therapeutic aspects such as vaccines, immunoglobulins, preventive practices, chemoprophylactic drugs, educational/behavioural interventions and interventional agents or drugs.
"People willing to volunteer for the vaccine trial can contact the institute. All details are displayed on its website," the professor said. The centre will go through the profiles and conduct a thorough screening to choose the suitable ones.
"We will screen the prospective volunteers and thoroughly evaluate their health condition before administering them the vaccine," Rao said.
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, he said.
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, Rao said.
All four phases of the clinical trials involving human subjects would be conducted at the centre, he said.
"We are committed to the maintenance of quality, ethics, patient safety and confidentiality at the highest level. We conduct clinical trials involving investigational drugs or molecules approved by the DCGI and the Central Drug Standardisation Control Organisation (CDSCO)," he said.
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.
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, Rao said. They will be given two doses within a gap of 14 days, he added.
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