South Korea’s Genexine said on Wednesday it has received regulatory approval for Phase 2 and 3 clinical trials for its Covid-19 vaccine candidate GX-19N in Indonesia, marking it the first pivotal clinical trial of a Korean Covid-19 vaccine to be conducted overseas.
Genexine said it will conduct the two clinical trials simultaneously for speedy development of the vaccine. The Phase 3 study will begin with 300 healthy volunteers in Indonesia to evaluate the vaccine’s efficacy and safety. The company aims to expand the scope of subjects in a global clinical program to 10,000 volunteers around the world and then to 30,000 if the vaccine is proven effective against Covid-19 variants.
In the Phase 3 trial, participants will be randomized to receive either Genexine’s vaccine or placebo. The vaccine candidate must provide at least 60 percent chance of protection to be authorized for use.
The company said it will not be difficult to recruit subjects in Indonesia where caution is highly required amid a surge in new confirmed cases in the world’s fourth most populous country.
GX-19N is a DNA-based vaccine being developed by a consortium led by Genexine. It targets both SARS-CoV-2’s spike and nucleocapsid protein (NP) antigens. This vaccine is known to induce a broad and strong T-cell immune response and is expected to show high protection against Covid-19 variants.
Genexine is also preparing to conduct Phase 2 and 3 clinical trials in South American and Africa.
By Park Yoon-gyun and Minu Kim
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]