GC Green Cross Receives MFDS Approval for Tdap Vaccine Phase 1/2 Clinical Trial

Developed Entirely In-house
From Raw Materials to Finished Product

GC Green Cross announced on the 14th that it received approval for the clinical trial plan (IND) for phase 1/2 of 'GC3111B,' an adult tetanus, diphtheria, and pertussis combination vaccine (Tdap) development project, from the Ministry of Food and Drug Safety on the 12th.

GC Green Cross headquarters exterior. Photo by GC Green Cross

In this clinical trial, GC Green Cross plans to evaluate the safety and immunogenicity of GC3111B vaccination in 120 healthy adults aged 19 to 64. The clinical trial is scheduled to be completed by the end of 2026.

The Tdap vaccine is classified as a national essential vaccination vaccine, but all vaccines currently distributed domestically are imported. In particular, pertussis is highly contagious, with a secondary attack rate within families reaching about 80%, and the protective immunity from vaccination does not last more than 10 years, making periodic vaccination necessary.

Based on its success in 2018 as the first domestic supplier of the Td vaccine (tetanus and diphtheria), GC Green Cross is promoting the localization of the Tdap vaccine through support from the Ministry of Health and Welfare's 'Vaccine Commercialization Technology Development Project Group' for the GC3111B project.

The company aims not only for domestic product approval of GC3111B but also for supply to international organizations such as UNICEF and the Pan American Health Organization (PAHO) through the World Health Organization (WHO) prequalification (PQ) in the future. The strategy includes strengthening national competitiveness by increasing exports alongside vaccine self-sufficiency.

Jae-woo Lee, Head of Development at GC Green Cross, stated, "GC3111B can develop and produce all antigens from the raw pharmaceutical ingredients, and especially holds its own patent for the pertussis manufacturing process, which is highly significant for achieving complete vaccine self-sufficiency. We will accelerate vaccine development through the initiation of this clinical trial."