Ahmedabad-based Zydus Cadila’s ZyCoV-D COVID vaccine, targeted to hit markets by early next year, has successfully cleared the first phase of clinical trials. The second phase of human clinical trials, involving 1,000 volunteers, will begin on August 6. The vaccine, using the platform of plasmid DNA, was found to be safe and well-tolerated in Phase I, which began on 15 July, said 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 the vaccine was found to be very safe.
The adaptive phase I/ II human clinical trials of ZyCoV-D have commenced with the first human dosing, it said, adding that “the adaptive phase I/II dose-escalation, the multi-centric study will assess the safety, tolerability, and immunogenicity of the vaccine.”
Earlier this month, Zydus had received approval from domestic authorities to start human trials for its COVID-19 vaccine contender – the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide.
We now begin the Phase 2 clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population,” said Pankaj Patel, chairman, Zydus Cadila. The seven-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), constituted to oversee the safety aspects of the clinical trial, said Zydus.
Last month, Zydus had received approval from domestic authorities to start human trials for its Covid-19 vaccine contender – the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide.
Experts say if successful, Zydus’s vaccine will be easy to make as it uses the plasmid DNA platform. A plasmid is a small DNA molecule within a cell that is physically separated from chromosomal DNA and can be replicated independently. When the plasmid DNA is introduced into the host cells, it translates into viral protein and elicits a strong immune response.
It is safer since it is a non-replicating and non-integrating plasmid carrying the gene of interest. Also, no vector response or infectious agents are used in the development of technology. It is easy to make with minimal biosafety requirements (BSL-1) and has lower cold chain requirements, making it easy for transportation to remote regions. Further, the platform can be rapidly used to modify the vaccine within a couple of weeks in case the virus mutates.
