The Second Phase of the human clinical trial of ‘Covaxin‘ is about to start and the chosen hospital by the Indian Council for Medical Research is busy with the preparations. Dr. E Ventaka Rao, Principal Investigator of the trial at IMS and SUM Hospital, commented, “Phase I of the trial is still not over as we proceed towards the Phase II trial shortly.”
Trial scenario to date
Blood samples are collected from the volunteers who participated in receiving the vaccine in the first Phase. They are yet to ascertain the effectiveness of the vaccine concerning antibodies development. However, Dr. Rao confirmed that no immediate ‘side effects’ were seen in the first phase trial.
As reported by Bharat Biotech, the Phase-II human trial of the Covid-19 vaccine candidate Covaxin, was about to start from the first week of September. The company has been working in collaboration with the Indian Council of Medical Research and the National Institute of Virology towards developing the vaccine and its clinical trial.
The volunteer recruitment process has started long before across the 12 selected clinical trial sites. Human trials of Covaxin were initiated by Bharat Biotech back on July 15. That is a double-blind placebo-controlled and a randomized trial along with 375 volunteers in India.
The Drug Controller General of India granted the permission of starting Phase I and II after receiving the company’s pre-clinical study results and a demonstration of immune and safety responses. However, the drug’s effectiveness on the first Phase is still in anonymity, and the DCGI is expected to submit a good clinical data by the end of the current month. When enquired about the same, the company refused to furnish any detail. However, a source said near about 750 more volunteers are yet to get recruited for the second phase trial.
Challenges faced in Phase I
An investigator said, “The Phase I trial is almost over in the majority of the centers, and the initial results show that Covaxin does not have any adverse effect and is safe.” He further shed light on the fact that the second round would put further emphasis on the efficacy of the drug. Sources added that the volunteer recruitment process started a bit late during the initial days as the subjects lacked any incentives except travel and food. Moreover, there was also a lack of awareness of several trial strategies.
The CMD of Bharat Biotech, Krishna Ella, commented earlier that the importance of testing the Covid-19 vaccine for quality and safety was immense. He further added that there was pressure on the company in the initial days to come out with an effective vaccine amidst the pandemic. However, it was impossible to rush. “We have been doing clinical research of the highest standards being monitored by the international communities and agencies. We won’t be restricting our research and will come up with the best quality vaccine,” he said.
The Policy Times suggestion
- In the Phase I trial, healthy volunteers are recruited as the trial focused mainly to check safety in smaller groups. A larger volunteer base is required in the second and the following phases to come.
- Blood samples should be collected on different days at a measured interval to calculate the duration of protection.