India’s pharmaceutical company Zydus Cadila’s Vaccine candidate for Covid-19 named ‘ZyCoV-D’ claimed to have completed Phase I of clinical trials. According to a press release on its website dated on 5th August 2020, the company said to enter Phase II clinical trials from 6th August 2020.
The Phase I of this vaccine candidate began on 15th July 2020 and was administered to healthy volunteers, has been well-tolerated and found to be safe. These subjects were strictly monitored in a clinical pharmacological unit for 24 hours post-dosing for safety. The safety of this vaccine candidate on subjects was assessed and endorsed by the independent Data Safety Monitoring Board (DSMB) for Seven days.
Safety and immunogenicity will further be evaluated in a larger population in Phase II of clinical trials.
Earlier, ZyCoV-D was found to be safe, immunogenic, and well-tolerated in pre-clinical toxicity studies before commencing Phase I clinical trials.
Phase II Clinical trials for ZyCoV-D
“Phase II will be conducted over 1000 healthy adult volunteers as part of the Adaptive Phase I/II dose-escalation, multicentric, randomized, double-blind placebo-controlled study”- press release stated.
ZyCoV-D is a non-integrative and non-replicative plasmid carrying the gene of interest from the virus (in this case SARS-CoV-2). It is safe as there is no vector response and presence of any infectious agent. This provides ease of manufacturing and minimum safety lab, BSL-1 is required.
It can be easily manipulated/modified in cases if the virus mutates. It is stable and can be transported easily.
ZyCoV-D as Immunogen
Immunogens are those antigens that elicit the activation of the immune system. ZyCoV-D on injection, which is a plasmid, on introduction to host cells elicits a strong immune response (Immunogenicity) by translation of non-infectious viral proteins. This strong immune response is mediated by the cellular and humoral responses of the immune system.
For more information, visit Zydus Cadila’s website.