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Zydus Cadila, on July 1-5 said that it has begun giving its possible coronavirus (COVID-19) vaccine to healthy volunteers in the first and second phases of human clinical trials across multiple sites.
“Zydus has already manufactured clinical GMP batches of this vaccine candidate and intends to commence the clinical trials in July 2020 across multiple web sites in India in over 1000 subjects,” the company said.
In accordance with the Clinical Trial Registry of India (CTRI) data that was upgraded on July 4, the Phase 1 at which the vaccine is going to be tested for safety is forecast to be completed in 84 days, and Phase 2 at which the vaccine will be analyzed for safety, efficacy, will compared with placebo and it is predicted to take 8-4 days.
The CTRI data mentions one clinical trial site of Zydus Research Centre at Ahmedabad. The ethics committee related to site has declared the trial.
Zydus had earlier this month announced that its plasmid DNA vaccine candidate (ZyCoV-D) grown in its Vaccine Technology Centre in Ahmedabad, India had successfully completed the preclinical period and had received permission from the Drug Controller General of India (DCGI) consent to commence Adaptive Phase I/II human clinical trials in India.
“From the pre-clinical phase, the vaccine has been found to evoke a robust immune response in multiple animal species like rats, rodents, guinea pigs and rabbits. The antibodies made by the vaccine could neutralize the wild type virus in virus neutralization assay indicating the protective potential for the disease candidate. No safety concerns were observed for its vaccine candidate at repeat dose toxicology studies by both intramuscular and intradermal routes of administration,” the company said.
With ZyCoV-D,” the company said that it has successfully established the DNA vaccine platform in the country utilizing non-replicating and non-integrating plasmid carrying the gene of interest which makes it very safe and sound.
“Further, no vector answer with lack of any contagious agent, the platform provides simple fabricating the vaccine using minimal biosafety conditions (BSL-1),” the company added.
