CHA Vaccine, an affiliate of CHA Biotech, said on the 18th that it received Ministery of Food and Drug Safety approval for an investigational new drug (IND) application for a phase 2 clinical trial of its recombinant protein shingles (herpes zoster) preventive vaccine candidate, "CVI-VZV-001."
The phase 2 trial will enroll 135 healthy adults ages 50 and older. The goal is to evaluate the immune response and safety of CVI-VZV-001 and identify the optimal dose to use in a future phase 3 trial. The clinical trial will be conducted at seven medical institutions in Korea.
CVI-VZV-001 is a recombinant shingles vaccine that applies CHA Vaccine's proprietary immune enhancer "Lipo-pam™." Lipo-pam is designed to suppress viral activity by inducing not only antibody production but also a cellular immune response. It focuses on addressing the limitations of existing live vaccines, whose immune response may be limited in older adults.
Since recombinant protein vaccines were commercialized, the shingles vaccine market has rapidly shifted toward recombinant vaccines that emphasize safety and efficacy. In Korea, overseas products are being used, but the need to develop a domestically produced vaccine has been consistently raised due to cost burdens.
This trial will particularly focus on evaluating the immune response and safety in adults ages 65 and older. The results will serve as evidence to gauge preventive effectiveness in older adults and will be used to design a phase 3 trial and establish prevention strategies.
Han Seong-il, CEO of CHA Vaccine, said, "We are expediting the phase 2 trial and are reviewing the possibility of advancing to both a domestic phase 3 and overseas clinical trials," and added, "Aiming to localize the recombinant shingles vaccine, which relies entirely on imports, we will prepare a mid- to long-term strategy for global partnerships and overseas expansion."