OdishaPlus Bureau

Drug firm Zydus Cadila on Wednesday announced that it will commence phase II clinical trials from August 6 after ZyCoV-D was found to be safe and well-tolerated in phase I clinical trial. The company stated that the doses of the vaccine administered to healthy volunteers were well tolerated in phase I clinical trial that started on July 15.

Pankaj R. Patel, Chairman of Zydus Cadila said, “We now begin the phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population.” Subjects in phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post-dosing for safety and for seven days thereafter and the vaccine was found to be very safe.

The statement came a day after Director General of Indian Council of Medical Research Balram Bhargava said that the DNA vaccine by Zydus Cadila has completed phase I trials and embarked on phase II at 11 sites. Previously, the vaccine was found to be safe, immunogenic and well-tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit a high level of neutralisation of antibodies in animal studies. The phase II trial will be evaluating the humoral and cellular immune response for the vaccine candidate in line with the current global clinical trial protocols in general.

With ZyCoV-D, the company has successfully established the DNA vaccine platform in the country using non-replicating and a non-integrating plasmid carrying the gene of interest making it very safe. According to the ICMR there are 141 vaccine candidates which are being studied the world over, out of which 26 are in different phases of the clinical trial. Three vaccines are in different phases of clinical testing in India.