CHA Vaccine Research Institute, a subsidiary of CHA Biotech, has received approval from the Ministry of Food and Drug Safety for a phase 1 clinical trial plan (IND) for ‘CVI-VZV-001’, a candidate for recombinant protein zoster vaccine.
CHA Vaccine Research Institute plans to evaluate the safety and tolerability of CVI-VZV-001 by dose in 24 healthy adults between the ages of 50 and 65 in this clinical trial. Then it is planning to observe the maximum administered dose, the recommended dose for phase 2 clinical trials, and immunogenicity.
CVI-VZV-001 is a recombinant protein shingles vaccine based on the immune enhancement platform ‘Lipo-pam™’ developed by CHA Vaccine Research Institute. Lipo-Pharm prevents shingles by inducing a cellular immune response and suppressing the activation of the zoster virus in a latent infection state.
Shingles occurs when the varicella-zoster virus lies dormant in the nerve cells and weakens the immune system. Currently, two types of prophylactic vaccines have been commercialized: live attenuated vaccines and recombinant protein vaccines. Among them, live attenuated vaccines are evaluated as lacking in the protective effect for the elderly, while currently released recombinant protein vaccines have excellent protective effects even in the elderly, but the immunostimulant included in the vaccine causes severe pain.
The immune enhancing substance applied to CVI-VZV-001 is also used in a chronic hepatitis B treatment vaccine currently in phase 2b in Korea, but there are no reports of severe pain. The recombinant protein vaccine of the CHA Vaccine Research Institute is expected to suppress “post-herpetic neuralgia (PHN)” by maximizing the cellular immune response in the body.
“CVI-VZV-001 is expected to have a more preventive effect by improving the problems of existing vaccines and applying the immunity enhancement platform technology independently developed by the CHA Vaccine Research Institute,” said Yeom Jung-sun, CEO of the CHA Vaccine Research Institute. “Starting with this phase 1 clinical trial, we will do our best to accelerate the commercialization of the product by promptly conducting clinical trials.”
Source: Pangyo Techno Valley Official Newsroom