The vaccine candidate was found ‘very safe’ after volunteers in the Phase I trial were examined at 24 hours and 7 days after the shot.
Zydus Cadila announced Wednesday that its plasmid DNA vaccine to prevent COVID-19, going by the name ZyCoV-D, was found to be both safe and well-tolerated in healthy volunteers in Phase I human trials, which began on 15 July 2020. The vaccine candidate will begin Phase II trials on Thursday, 6 August, the company said.
“The Phase I dosing to establish the safety of ZyCoV-D is an important milestone,” Pankaj Patel, Chairman of Zydus said in a statement. “All the subjects in Phase I clinical trial were closely monitored…for 24 hours post dosing for safety, and for 7 days thereafter…and [the] vaccine was found to be very safe.”
The Phase II trail of the ZyCoV-D vaccine candidate beginning soon will be a multicentric, randomized, double-blind, placebo controlled study in over 1000 healthy adult volunteers. This adaptive Phase I/II trial will examine the humoral and cellular immune response of the vaccine candidate, and whether the antibodies produced by the body in response to it can neutralize the SARS-CoV-2 virus. The durability of this response up to 6 months after the last dose will also be evaluated, the company said.
The ZyCoV-D vaccine candidate uses plasmids – a standard template of DNA sources from bacteria and adapted for use in research and medicine – to help the body produce some specific SARS-CoV-2 proteins. These proteins act as targets for the immune system, which produces an immune response under the assumption that the body is under attack from the coronavirus. The antibodies made in the process help in ‘viral clearance’, killing any coronavirus particles it encounters in the blood in the future.
The vaccine candidate developed by Zydus was supported by the Department of Biotechnology via the National Biopharma Mission and the Biotechnology Industry Research Assistance Council (BIRAC).