Gujarat based pharmaceutical company Zydus Cadila on Wednesday, July 15th has begun the human trials of its potential coronavirus vaccine. The company had developed plasmid DNA vaccine candidate- ZyCoV-D at its Vaccine Technology Center at Ahmedabad. The Potential coronavirus vaccine of Zydus Cadila has completed the preclinical phase successfully and received permission from the Drug Controller General of India (DCGI) to initiate the human trials.
The vaccine was found in the pre-clinical process to induce a strong immune response in various species of animals such as mice, rats , guinea pigs and rabbits. The vaccine-producing antibodies were able to neutralize the wild type virus in a virus neutralization assay showing the vaccine candidate’s protective ability. No safety issues were found in repeat dose toxicology studies for the vaccine candidate via both intramuscular and intradermal routes of administration
The human clinical trials of DNA vaccine candidate ZyCoV-D will take place in two phases. The human clinical trials of Adaptive Phase I and II of its plasmid DNA vaccine, ZyCoV-D, started yesterday with the first human dose where a multicentric analysis would test the health, tolerability and immunogenicity of the vaccine. For Phase 1 the organization chose healthy men and women between the ages of 18 and 55 (non-pregnant and non-lactating). Healthy volunteers will be chosen for Phase 2, from either group aged 12 or above. The company must obtain consent from the subjects or the parents of the 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.
The clinical GMP samples of the potential coronavirus vaccine of Zydus Cadila has already been developed, and aims to launch clinical trials in more than 1000 subjects at multiple sites in India. The CTRI data lists one Zydus Research Centre’s clinical trial site in Ahmedabad. The trial has been accepted by the site specific ethics committee.