India-based Zydus Cadila has launched Phase II clinical trials of its Covid-19 vaccine candidate, ZyCoV-D, which showed promise in a Phase I study.
The company completed dosing in the Phase I trial, where the vaccine was found to be safe and well tolerated in healthy participants.
In pre-clinical toxicity studies, the vaccine demonstrated favourable safety, immunogenicity and tolerability. The candidate was observed to induce high level of neutralising antibodies in animals.
Zydus Cadila chairman Pankaj Patel said: “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 seven 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.”
An independent Data Safety Monitoring Board (DSMB) endorsed the seven day safety of the vaccine in all the Phase I participants, noted the company.
The Phase II trial will be performed in more than 1,000 healthy adults. It is part of an adaptive, multi-centric, randomised, double-blind placebo controlled Phase I/II dose escalation study.
ZyCoV-D is a plasmid DNA vaccine candidate. When delivered into the host cells, the plasmid DNA is known to translate into the viral protein and trigger a strong cellular and humoral immune response.
The development of the Covid-19 vaccine candidate was supported by National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India.
Zydus started dosing participants in the Phase I/II clinical trial of ZyCoV-D last month.
The company has already manufactured clinical batches of the vaccine for the human trials. It developed the candidate at its Vaccine Technology Centre in Ahmedabad, India.