Covid-19 vaccine found safe in Phase I trial, Phase II begins tomorrow, says Zydus Cadila
The company said that the focus of the Phase II trial will be on evaluating the humoral and cellular immune response for the vaccine candidate
Indian pharmaceutical company Zydus Cadila today said its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D, was found to be safe and well-tolerated in Phase I clinical trial. The Phase II clinical trials will begin from 6th August 2020, said a LiveMint report quoting the company’s statement.
“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,” Pankaj R. Patel, Chairman Zydus Cadila was quoted as saying in the report.
The company further said that the aim of the Phase II trial will be evaluating the humoral and cellular immune response for the vaccine candidate. The neutralization potential of the antibodies produced by the vaccine would also be checked by virus neutralization assay. Phase II will also evaluate the durability of the humoral response up to six months post the last dose, the company was quoted as saying in the LiveMint report.
It is known that the phase I trial of another potential COVID vaccine developed by Bharat Biotech, in collaboration with ICMR, has also been completed.
Over 100 vaccine candidates are in development globally and over two dozen are in different phases of clinical trials.