Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above
A Multicenter, Active-controlled, Randomized, Double Blinded, Parallel, Phase II Study to Assess the Immunogenicity and Safety of CVI-VZV-001 in Healthy Adults Aged 50 Years and Above
1 other identifier
interventional
135
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2026
CompletedFirst Posted
Study publicly available on registry
March 19, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
March 19, 2026
March 1, 2026
9 months
March 13, 2026
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody
Geometric mean fold rise (GMFR) of anti-VZV gE antibodies measured by ELISA from baseline to 4 weeks after the second vaccination.
Baseline to 4 weeks after the second vaccination
Secondary Outcomes (5)
Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody at Additional Time Points
Before the second vaccination and at 8 and 24 weeks after the second vaccination
Geometric Mean Concentration (GMC) of Anti-VZV gE Antibody
Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Vaccine Response Rate (VRR) of Anti-VZV gE Antibody
Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Polyfunctional CD4+ T Cell Response
4 and 8 weeks after the second vaccination
Geometric Mean Concentration (GMC) of Anti-VZV Antibody
Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Study Arms (3)
CVI-VZV-001 Low Dose
EXPERIMENTALParticipants receive two doses of the investigational herpes zoster vaccine CVI-VZV-001 at the low dose level administered intramuscularly on Day 0 and Week 8.
CVI-VZV-001 High Dose
EXPERIMENTALParticipants receive two doses of the investigational herpes zoster vaccine CVI-VZV-001 at the high dose level administered intramuscularly on Day 0 and Week 8.
Shingrix
ACTIVE COMPARATORParticipants receive two doses of the licensed herpes zoster vaccine Shingrix administered intramuscularly on Day 0 and Week 8.
Interventions
Investigational herpes zoster vaccine.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Kyungpook National University Chilgok Hospital
Daegu, Daegu, South Korea
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Yongin Severance Hospital, Yonsei University Health System
Yongin, Gyeonggi-do, South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Seoul, Seoul, 03312, South Korea
Chung-Ang University Hospital
Seoul, Seoul, South Korea
Ewha Womans University Seoul Hospital
Seoul, Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2026
First Posted
March 19, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03