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Clinical Trials in South Korea / NCT07481604
Starting soon Phase 2

Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above

NCT07481604 · tracked via the Priya Life Science South Korea tracker
Sponsor
Aribio Lab Co., Ltd
Phase
Phase 2
Started
2026-04
Last updated
2026-03-19

Condition(s) studied

Herpes Zoster

Investigational drug(s) / intervention(s)

Shingrix →CVI-VZV-001 →

Shingrix: Licensed herpes zoster vaccine used as an active comparator.

CVI-VZV-001: Investigational herpes zoster vaccine.

Study summary

To evaluate the immunogenicity of the investigational product (IP) in healthy adults aged 50 years or older and to explore differences in immune responses between the experimental and control groups, and to determine the optimal dose of the IP.

Eligibility

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Participants must meet all of the following criteria: * Healthy adults aged 50 years or older * Able to understand the study procedures and provide written informed consent * Females and males of reproductive potential must agree to use medically acceptable contraception until 3 months after the last vaccination * Females of childbearing potential must have a negative pregnancy test prior to vaccination Exclusion Criteria: * Participants meeting any of the following criteria will be excluded: * History of herpes zoster prior to screening * History of severe allergic reaction to vaccines or vaccine components * Known immunodeficiency or immune dysfunction * Prior vaccination with varicella or herpes zoster vaccine * Use of immunosuppressive therapy or systemic steroids that may affect immune response * Positive test for HCV, HBV, or HIV at screening * Pregnant or breastfeeding women * Any medical condition that, in the opinion of the investigator, would make participation unsafe or interfere with study evaluation

Primary outcome measure(s)

  • Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody — Baseline to 4 weeks after the second vaccination
    Geometric mean fold rise (GMFR) of anti-VZV gE antibodies measured by ELISA from baseline to 4 weeks after the second vaccination.

Trial sites (7)

FacilityCityRegionStatus
Kyungpook National University Chilgok Hospital Daegu Daegu
CHA Bundang Medical Center Seongnam-si Gyeonggi-do
Yongin Severance Hospital, Yonsei University Health System Yongin Gyeonggi-do
Jeonbuk National University Hospital Jeonju Jeollabuk-do
The Catholic University of Korea Eunpyeong St. Mary's Hospital Seoul Seoul
Chung-Ang University Hospital Seoul Seoul
Ewha Womans University Seoul Hospital Seoul Seoul

More Aribio Lab Co., Ltd. trials in South Korea

Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above Recruiting

Other trials for the same condition

Safety and Immunogenicity of CVI-VZV-001 for Prevention of Herpes Zoster in Healthy Adults Age 50 Years and Above Recruiting
Clinical Trial to Evaluate EuHZV in Healthy Adults Aged 50 to 69 Years Active, not recruiting
A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07481604 on ClinicalTrials.gov ↗ ← All trials in South Korea