Zydus starts human trials of ZyCoV-D, its COVID-19 vaccine
The company will be enrolling over 1000 subjects across multiple clinical study sites in India for Adaptive Phase I/ II clinical trials
Zydus announced that the Adaptive Phase I/ II human clinical trials of its plasmid DNA vaccine, ZyCoV-D commenced today with the first human dosing. The Adaptive Phase I/II dose-escalation, the multi-centric study will assess the safety, tolerability and immunogenicity of the vaccine.
Pankaj R Patel, Chairman, Zydus Cadila said, “This is an all-important step in our fight against COVID-19. We acknowledge the support of National Biopharma Mission, BIRAC, Department of Biotechnology, Govt. of India and regulatory agencies ICMR and DCGI in the development of ZyCoV-D vaccine candidate. We look forward to the Adaptive Phase I/IIclinical studies and gathering important data on ZyCoV-D in the months ahead.”
In the Adaptive Phase I/ II clinical trials, Zydus will be enrolling over 1000 subjects across multiple clinical study sites in India. The company has already manufactured clinical GMP batches of the vaccine candidate for the clinical trials, stated a company release.
The company informs, “In the pre-clinical phase, the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to neutralize the wild type virus in virus neutralisation assay indicating the protective potential of the vaccine candidate. No safety concerns were observed for the vaccine candidate in repeat-dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well-tolerated and immunogenic.”