GC Green Cross Publishes Clinical Results of Anthrax Vaccine "Beritrax Injection" in International Journal

Demonstrated Safety and Immunogenicity

GC Green Cross announced on the 3rd that the results of Phase 2 clinical trials for its anthrax vaccine, "Beritrax Injection," have been published in the international journal "Vaccine." Beritrax Injection is the world's first recombinant anthrax vaccine, jointly developed by GC Green Cross and the Korea Disease Control and Prevention Agency.

The exterior view of GC Green Cross headquarters in Yongin-gu, Seoul. GC Green Cross

This study was conducted at five hospitals: Seoul National University Hospital, St. Vincent's Hospital of the Catholic University of Korea, Korea University Ansan Hospital, Soonchunhyang University Seoul Hospital, and Hallym University Sacred Heart Hospital. The trial enrolled 240 healthy adults and was carried out as a randomized, double-blind, placebo-controlled study to evaluate the vaccine's safety and immunogenicity. Participants received either Beritrax Injection or a placebo, and the researchers analyzed antibody levels generated after vaccination and monitored for adverse reactions.

The results showed that antibodies neutralizing anthrax toxins were produced above the reference threshold, demonstrating a strong vaccine effect. This is considered significant evidence that Beritrax Injection can effectively protect the human body even in actual anthrax infection scenarios.

Additionally, in the safety assessment, the main adverse events in the Beritrax Injection group were mostly mild and transient, such as pain at the injection site, muscle pain, fatigue, and malaise. There were no cases of acute adverse reactions or deaths, confirming the vaccine's excellent safety profile.

The company explained that Beritrax Injection offers higher safety than conventional methods that use attenuated bacteria directly, and it can also be rapidly mass-produced when necessary.

Kim Namjoong, the principal investigator for this clinical trial and a professor at Seoul National University Hospital, stated, "This study is a good example of close collaboration between academia and industry and will serve as an important milestone for the development of safe and effective vaccines. I hope the success of the first recombinant anthrax vaccine developed in Korea will become a meaningful foundation for future research on infectious disease response and vaccine self-sufficiency."

Jung Jaeuk, Head of R&D at GC Green Cross, said, "Through these clinical results, we have successfully demonstrated the safety and efficacy of Beritrax Injection. We aim to contribute to strengthening the national disease control system with a domestically produced anthrax vaccine."