Zydus Cadila has launched phase II clinical trials of its COVID-19 vaccine candidate, ZyCoV-D, following its successful results from phase I study where the vaccine was found to be safe and well-tolerated in healthy participants.
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 the vaccine was found to be very safe, said Pankaj Patel, chairman, Zydus Cadila. An independent Data Safety Monitoring Board (DSMB) endorsed the seven-day safety of the vaccine in all the phase I participants, noted the company.
“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 adaptive, multi-centric, randomised, double-blind placebo-controlled trial will enroll more than 1,000 healthy adults.
ZyCoV-D is a plasmid DNA vaccine candidate which upon delivery into the host cells, will induce translation into the viral protein and trigger a strong cellular and humoral immune response.
The development of the COVID-19 vaccine candidate was supported by the National Biopharma Mission, BIRAC, Department of Biotechnology, Govt of India.