Bharat Biotech, which is running in the Covid-19 Covaxin candidate vaccine in collaboration with the Indian Medical Research Council (ICMR) and the National Institute of Virology (NIV), Pune, is likely to begin its phase II huguy trials as early as the first week of September. The volunteer recruitment procedure has begun at 12 designated clinical trial sites. The company began testing the Covaxin type on July 15. This is a randomized, double-blind, placebo-controlled clinical trial with approximately 375 volunteers in India.
The Comptroller General of Medicines of India (DCGI) granted permission to initiate Phase I and Phase II human clinical trials after the company presented the effects of preclinical studies demonstrating immune protection and response. “Good clinical knowledge of more than 375 subjects is expected to be presented to DCGI until the end of the month,” said a NIMS researcher in Hyderabad, one of 12 control sites, under anonymity status. When asked, the company did not reveal any details. However, resources said the company is looking to recruit about 750 volunteers for the next phase.
“The Phase 1 test at the maximum centres is at full maximum. Preliminary effects show that Covaxin is safe and without adverse effects,” the researcher said, adding that the next phase would further detail the facet of efficacy. Sources said there was some delay in recruiting volunteers in the early days, as there were no incentives for subjects, unless they were food and travel, in addition to a lack of knowledge about testing protocols.
Krishna Ella, CMD of Bharat Biotech, had stated in the past that testing the Covid-19 vaccine for protection and quality was of paramount importance, while emphasizing that while there is pressure on the company to offer a vaccine temporarily in the midst of the pandemic, it cannot rush. “We need to do clinical studies to the highest standards. We were followed by foreign agencies and communities. We will not be shortsighted in the studies and produce the vaccine of the most productive quality,” he said.
In Phases I and II of a trial, healthy volunteers are recruited. While the Phase I trial is a smaller protection control, a larger volunteer base is being created through Phase II and Phase III recruitment to assess efficacy and protection. According to the protocol, Covaxin is controlled in a pattern of 1,125 participants. Up to 12 sites have been decided for human trials, adding All India Institute of Medical Sciences (AIIMS) New Delhi, AIIMS Patna, PGI Rohtak in Haryana, Redkar Hospital in Goa, Institute of Medical Sciences and SUM Hospital in Bhubaneswar, NIMS in Hyderabad, KGH in Vizag. In addition, there are control sites in Belgaum, Nagpur, Gorakhpur, Kanpur and Katankulathur.
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