Zydus Cadila announced that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D was found to be safe and well-tolerated in Phase I clinical trial. The company will now commence Phase II clinical trials from August 6, 2020. The company reports that the doses of the vaccine administered to healthy volunteers in Phase I clinical trial, which began on July 15, 2020, has been well-tolerated. 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 neutralising antibodies in animal studies.
“The Phase I dosing to establish the safety of ZyCoV-D is an important milestone. All the 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. We now begin the Phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population,” said Pankaj R Patel, Chairman, Zydus Cadila.
The seven-day safety of the vaccine in all the subjects enrolled in Phase I clinical trial has been endorsed by the independent Data Safety Monitoring Board (DSMB), which has been constituted to oversee the safety aspects of the clinical trial. The Phase II study of ZyCoV-D will be conducted in over 1000 healthy adult volunteers as part of the Adaptive Phase I/II dose-escalation, multicentric, randomized, double-blind placebo-controlled study.