India’s Second COVID19 vaccine By Zydus Cadila starts human trials in 1,000 volunteers
On Wednesday, Ahmedabad-based pharma company Zydus Cadila said it has begun human clinical trials of its COVID19 vaccine candidate ZyCoV-D – deoxyribonucleic acid (DNA) plasmid vaccine.
In a regulatory declaring, the firm said that in the phase of trials, they will be enrolling over 1,000 volunteers across multiple clinical research sites in India.
The company stated that the adaptive phase I/ II human clinical trials of ZyCoV-D have started with the initial human dosing, and the adaptive phase I/II dose-escalation, the multi-centric study will analyze the immunogenicity, safety, and tolerability of the vaccine.
Previously this month, the firm had received authorization from domestic authorities to start human trials for its COVID-19 vaccine competitor. The 2nd Indian pharma company to obtain a green signal amid a surge in novel coronavirus infections around the globe.
After few days of India’s first indigenous COVID19 vaccine candidate COVAXIN, by Bharat Biotech in partnership with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), Pune, got approval for human clinical trials from the Drug Controller General of India (DCGI), the second vaccine candidate by Zydus also got approval
.Pre-clinical studies for this vaccine were done on multiple animal species like mice, rabbits, guinea pigs, and rats.
The wild type virus in virus neutralization assay was neutralized by the antibodies produced by the vaccine, indicating the protective potential of the vaccine candidate.
According to the company, in repeated dose toxicology studies by both intramuscular and intradermal routes of administration, there were no safety concerns observed for the vaccine candidate. Additionally, in rabbits, up to 3 times the intended human dose was found to be safe, immunogenic, and well-tolerated.
Human trials commence with Phase 1, which involves administering vaccines to volunteers with informed consent and look for potential side effects. There are two kinds of adverse effects — any adverse immune reaction, and any toxic effect on any human body tissue (picked up by symptoms or biochemical parameters in the blood). Phase 2 of the human clinical trial checks the dosage of the vaccine and has two or more arms – in which people in one arm are given a single dose and in others are given two or more doses of the vaccine.
Author: Sruthi S
