Drug maker Zydus Cadila will start phase 2 clinical trials to establish the efficacy of its anti-coronavirus disease (Covid-19) vaccine candidate from Today, the company said on Wednesday.
Zydus Cadila said 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 phase I trial of another indigenously covid vaccine developed by Bharat Biotech, in collaboration with ICMR, has also been completed.
Zydus Cadila doses of the vaccine administered to healthy volunteers in the 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, Zydus Cadila said.
“The Phase I dosing to establish the safety of ZyCoV-D is an important milestone,” said Mr. Pankaj R. Patel, Chairman Zydus Cadila. “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.”
Zydus Cadila said the the phase II trial will be evaluating the humoral and cellular immune response for the vaccine candidate. 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, it added.
Globally, over 100 vaccine candidates are in development and over two dozen are in different phases of clinical trials.
The Oxford vaccine, to be manufactured by Serum Institute of India, has also been given approval yesterday for Phase 2 and 3 clinical trials which would start within a week at 17 sites in India.