[Asia Economy Reporter Lee Gwan-ju] ChabioTech affiliate Chavaccine Research Institute announced on the 6th that it has received approval from the Ministry of Food and Drug Safety for the clinical phase 1 trial plan (IND) of the recombinant protein shingles vaccine candidate 'CVI-VZV-001.'
Through this clinical trial, the safety and tolerability of CVI-VZV-001 will be evaluated by dosage in 24 healthy adults aged 50 to under 65 years, and the maximum dosage, recommended dosage for phase 2 clinical trials, and immunogenicity will be observed.
CVI-VZV-001 is a recombinant protein shingles vaccine based on 'Lipo-pam,' an immune-enhancing platform independently developed by Chavaccine Research Institute. Lipo-pam induces cellular immune responses to suppress the activation of latent shingles virus, thereby preventing shingles.
Shingles occurs when the varicella-zoster virus, which remains latent in nerve ganglia, is reactivated due to weakened immunity. Currently, two types of preventive vaccines are commercialized: live attenuated vaccines and recombinant protein vaccines. Live attenuated vaccines are considered to have insufficient preventive effects in the elderly, while recombinant protein vaccines show excellent protective effects in the elderly but have the drawback of causing severe pain due to the immune enhancers included in the vaccine. The immune-enhancing substance applied in CVI-VZV-001 is also used in a chronic hepatitis B therapeutic vaccine currently in phase 2b clinical trials in Korea, with no reports of severe pain.
Yeom Jeong-seon, CEO of Chavaccine Research Institute, said, "CVI-VZV-001 applies our independently developed immune-enhancing platform technology, improving the issues of existing vaccines and is expected to increase preventive efficacy." He added, "Starting with the approval of this phase 1 clinical trial, we will proceed swiftly with the trials and do our best to expedite product commercialization."
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