KCDC "Domestic Anthrax Vaccine Development, Clinical Phase 2 Step 2 Initiated"

Disease Control Agency and Green Cross Joint Development... Scheduled for Completion in 2024

[Asia Economy Reporter Kim Ji-hee] The Korea Disease Control and Prevention Agency (KDCA) announced that it received approval from the Ministry of Food and Drug Safety in March for the Phase 2 clinical trial (Step 2) plan of the domestically developed anthrax vaccine and commenced the clinical trial on the 30th.

The KDCA developed the anthrax vaccine candidate substance and production strain independently in 1998 and obtained a patent. Since 2002, through Green Cross Corporation as a commissioned project, it has carried out product development including production process development and non-clinical trials, completing Phase 1 clinical trials in 2009 and Phase 2 clinical trials (Step 1) in 2012 at Seoul National University Hospital.

The ongoing Phase 2 Step 2 clinical trial will evaluate efficacy by measuring antibodies formed in the vaccine group among 240 healthy adults, as well as assess safety by monitoring injection site pain, headache, fever, abdominal pain, chills, and other symptoms after vaccination.

Anthrax is a zoonotic infectious disease occurring in humans and livestock, with a high potential for misuse in bioterrorism. Currently, the BioThrax vaccine is approved and used for anthrax prevention in the United States, and the AVP vaccine is approved in the United Kingdom.

The anthrax vaccine developed this time is a recombinant vaccine with the protective antigen of Bacillus anthracis as the main component. It uses Bacillus brevis, a non-pathogenic strain with excellent mass production efficiency, as the expression system, which is expected to ensure safety and improve cost-effectiveness.

Jung Eun-kyung, Commissioner of the KDCA, stated, “Product approval after clinical trials is expected around 2024, and thereafter, domestic production and stockpiling of the anthrax vaccine for emergency preparedness will be possible.”

This content was produced with the assistance of AI translation services.