Drug maker Zydus Cadila will start phase 2 clinical trials to establish the efficacy of its anti-coronavirus disease (Covid-19) vaccine candidate.
“…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 doses of the vaccine administered to healthy volunteers in the Phase I clinical trial, which began on 15th July 2020, has been well tolerated,” Zydus Cadila said in a statement.
ZyCoV-D is designed to introduce DNA that encodes for a viral protein into human cells. By ordering human cells to make the protein, ZyCoV-D could elicit an immune response against the coronavirus. The approach is similar to that pursued by Inovio Pharmaceuticals. Like Inovio, Zydus sees the ability of its vaccine to withstand higher temperatures than some rival approaches as a differentiator.
The vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies conducted on animals. The vaccine was able to induce a high level of neutralizing antibodies in animal studies.
The company received the central drugs controller’s approval for human trials on July 2
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“The Phase I dosing to establish the safety of ZyCoV-D is an important milestone,” said 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,” he added.
The Phase II study of ZyCoV-D will be conducted in over 1,000 healthy adult volunteers.
“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 company said.
Zydus appear to be happy with the results of their Phase I trials and will now look forward to replacating their positive results in the Phase II trials.