CHA Vaccine’s shingles vaccine gets greenlight for clinical study

CHA Vaccine Institute received approval from the Ministry of Food and Drug Safety (MFDS) on Monday for a phase 1 clinical trial plan to develop CVI-VZV-001, a candidate for a recombinant protein shingles vaccine with the potential to suppress postherpetic neuralgia  (PHN) effects.

Accordingly, the institute plans to evaluate the dose-specific safety and tolerability of CVI-VZV-001 in 24 healthy adults aged 50 to 65 and observe the maximum and recommended dose, together with the immunogenicity of phase 2 clinical trials.

CVI-VZV-001 is a recombinant protein shingles vaccine based on Lipo-pam, an immune-enhancing platform developed by the CHA Vaccine Institute. Lipo-pam induces a cellular immune response to suppress the activation of the shingles virus in a latent infection state.

Shingles is caused by the varicella-zoster virus (VZV) which lurks in the ganglion when immunity is low.

Currently,  live attenuated vaccines and recombinant protein vaccines have been commercialized. However, the live attenuated vaccine is evaluated to have insufficient preventive effect on the elderly, while the recombinant protein vaccine has demonstrated excellent protective effects even in the elderly. The only caveat is that the immunostimulant contained in the recombinant vaccine causes severe pain.

However, the immunostimulant applied to Cha Vaccine’s CVI-VZV-001 is also used in the chronic hepatitis B treatment vaccine, which is currently progressing through phase 2b trials in Korea with no reports of serious pain, said a company official.

Additionally, there is no treatment for PHN, which lasts for more than three months and is one of the most common complications of shingles. This recombinant protein vaccine is also expected to maximize the cellular immune response in the body to suppress PHN effects.

"CVI-VZV-001 is expected to improve the problems of existing vaccines by applying the immune enhancement platform technology independently developed by CHA Vaccine Research Institute to increase the preventive effect," said CHA Vaccine Institute CEO Yum Jung-sun. "We will do our best to accelerate product commercialization by promptly proceeding with clinical trials starting with the approval of this phase 1 clinical trial.”