Pharmaceutical major Zydus on Wednesday started human clinical trials of its plasmid DNA vaccine ZyCoV-D — a potential COVID-19 vaccine.
The adaptive phase one and two dose-escalation, multi-centric study will assess the safety, tolerability and immunogenicity of the vaccine.
The human dosing of the vaccine marks a key milestone since the launching of the accelerated vaccine development programme for COVID-19 in February, the company said. “This is an all-important step in our fight against COVID-19,” said Chairman Pankaj R Patel. “We acknowledge the support of National Biopharma Mission, BIRAC, Department of Biotechnology and regulatory agencies ICMR and DGCI in the development of ZyCoV-D vaccine candidate,” he added.
Zydus will enroll over 1,000 subjects across multiple clinical study sites in India. The company has already manufactured clinical GMP batches of the vaccine candidate for clinical trials, it said in a statement.
In the pre-clinical phase, the vaccine was found to generate a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits.