Earlier this month, the company had released a statement saying that its indigenous vaccine candidate ZyCoV-D had completed its pre-clinical phase.
Coronavirus vaccine: Great news! Zydus Cadila begins human clinical trial of its COVID-19 vaccine candidate! As different teams of scientists all over the world are working on around 150 vaccine candidates for novel coronavirus-induced COVID-19, pharmaceutical company Zydus Cadila on Wednesday announced that it commenced the human clinical trials for plasmid DNA vaccine called ZyCoV-D with the first human dosing. The statement added that the adaptive phase I/II trials would assess the safety, tolerability as well as the immunogenicity of the vaccine candidate.
In a statement on its website, the company said that the trials will be a multi-centric study along with dose escalation. The company said that the vaccine’s human dosing is an important milestone after the accelerated vaccine development programme for COVID-19 was launched in 2020. The statement said that for its human clinical trials, the company would be enrolling more than 1,000 participants across different study sites in the country. It further stated that clinical GMP batches of the vaccine for the trials have already been manufactured.
The statement further quoted Zydus Cadila Chairman Pankaj R Patel as saying that the commencement of adaptive phase I/II human trials is a key step in the fight against COVID-19.
Zydus Cadila COVID-19 vaccine candidate: Pre-clinical trial results
Earlier this month, the company had released a statement saying that its indigenous vaccine candidate ZyCoV-D, which was developed at the Vaccine Technology Centre in Ahmedabad, had completed its pre-clinical phase and had received the permission of the Drug Controller General of India (DGCI) to commence the adaptive phase I/II human trials in the country.
The company had then said that during the pre-clinical studies conducted on animals like mice, rats, rabbits and guinea pigs, it was found that the vaccine candidate was able to generate a strong immune response. The vaccine was able to produce sufficient antibodies to completely neutralise the wild type virus, the company had added, further stating that even in repeat dose toxicology studies, no safety concerns had been observed. In fact, in rabbits, a dosage thrice the intended human dose was found to be tolerable, safe and immunogenic.