The Drug Controller General of India (DCGI) granted permission to initiate Phase-I and Phase-II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
Bharat Biotech, which is working on Covid-19 vaccine candidate Covaxin in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune, is likely to begin its Phase-II human trials from the first week of September. The process of volunteer recruitment has started across 12 designated clinical trial sites. The company started human trials of Covaxin on July 15. It is a randomised, double-blind placebo-controlled clinical trial with about 375 volunteers in India.
The Drug Controller General of India (DCGI) granted permission to initiate Phase-I and Phase-II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response. “A good clinical data, from more than 375 subjects, is expected to be submitted to the DCGI by this month-end,” an investigator from Hyderabad’s NIMS, one of the 12 trial sites, said on condition of anonymity. When asked, the company did not divulge any details. However, sources said the company was looking to recruit about 750 volunteers for the next phase.
“The Phase-1 trial in most of the centres is almost concluded. Preliminary results show that Covaxin is safe with no adverse effects,’’ the investigator said, adding that the next phase would further detail on the efficacy aspect. Sources said there was some delay in volunteer recruitment in the initial days because there was no incentive for the subjects except for food and travel, besides lack of awareness on various trial protocols.
Krishna Ella, CMD of Bharat Biotech, had earlier said testing the Covid-19 vaccine for safety and quality was of paramount importance, while stressing that though there was pressure on the company to come out with a vaccine quickly in the midst of the pandemic, it can’t rush. “We want to do clinical research of the highest standards. We have been monitored by international agencies and communities. We won’t be short-sighted on research and will produce the best quality vaccine,’’ he said.
In Phase-I and Phase-II of a trial, only healthy volunteers are recruited. While the Phase-I trial is to check for safety in smaller numbers, larger volunteer base is created through recruitment in Phase-II and Phase-III to assess efficacy and safety. According to protocol, Covaxin is being tested on a sample size of 1,125 participants. As many as 12 sites were selected for human trials, which include 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. Besides, there are test sites in Belgaum, Nagpur, Gorakhpur, Kanpur and Katankulathur.