Gujarat-based pharmaceutical giant Zydus Cadila on Wednesday said its coronavirus vaccine candidate, ZyCoV-D, has entered the human trials stage. The clinical trials will be conducted across multiple sites in India with over 1,000 subjects.
“The Adaptive Phase I/ II human clinical trials of its plasmid DNA vaccine, ZyCoV-D commenced today with the first human dosing,” said the company in a statement. “The Adaptive Phase I/II dose escalation, multi-centric study will assess the safety, tolerability and immunogenicity of the vaccine.”
The trials will be held in two phases. In phase 1, the company has selected healthy men and women (non-pregnant and non-lactating) between the ages of 18 and 55, reported ANI. For phase 2, healthy volunteers of either gender aged 12 or above will be selected. The company has to get consent from the subjects or from the parents of minor subjects.
The next is the exclusion criterion, which is also divided into two phases. The phase 1 trials will last for 84 days during which the safety of the vaccine candidate by intradermal route in healthy subjects will be evaluated. In phase 2, which will last for 224 days, the immunogenicity of the vaccine candidate by intradermal route in healthy subjects compared to the placebo will be evaluated.
“This is an all important step in our fight against Covid-19,” Zydus Cadila Chairman Pankaj Patel told News18. The firm had received the approval from the Drug Controller General of India to start phase one and two of human clinical trials of its coronavirus vaccine on July 3. In pre-clinical phase, the vaccine was found to elicit a “strong immune response” in mice, rats, guinea pigs and rabbits, the company had said.
Zydus Cadila’s ZyCoV-D is the second indigenous Covid-19 vaccine candidate. Bharat Biotech has already started human trials of its vaccine candidate, Covaxin.
India on Thursday reported over 32,000 coronavirus cases and 606 deaths. The country’s overall count rose to 9.66 lakh and the toll reached 24,915. As many as 6.12 lakh people have recovered so far.
So far, no vaccine has been approved for commercial use against the coronavirus. The World Health Organization had said last month that United Kingdom-based pharma firm AstraZeneca’s experimental vaccine was probably the leading candidate. The vaccine was developed by researchers at the University of Oxford. However, even this vaccine is not likely to be ready for human use until early next year.