Zydus Cadila completes Dosing in Phase-I Clinical Trial of ZyCoV-D, claims it is found to be safe and well tolerated

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Biznextindia: Pharma major Zydus Cadila on Wednesday announced that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D was found to be safe and well-tolerated in the Phase-I clinical trial. The company will now commence Phase II clinical trials from the 6th of August, 2020.

The Company has reported that the doses of the vaccine administered to healthy volunteers in Phase I clinical trial, which began on 15th July 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 high level of neutralizing 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 7 days thereafter and 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 Mr. Pankaj R. Patel, Chairman Zydus Cadila.

The 7 day safety of the vaccine in all the subjects enrolled in the 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 I 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. 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. The neutralization potential of the antibodies elicited by the vaccine would also be checked by virus neutralization assay. The durability of the humoral response up to 6 months post last dose will also be evaluated.

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