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

March 16, 2026 updated by: CHA Vaccine Institute Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Daegu
      • Daegu, Daegu, South Korea
        • Kyungpook National University Chilgok Hospital
        • Contact:
          • Study Coordinator
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea
        • CHA Bundang Medical Center
        • Contact:
          • Study Coordinator
      • Yongin, Gyeonggi-do, South Korea
        • Yongin Severance Hospital, Yonsei University Health System
        • Contact:
          • Study Coordinator
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, South Korea
        • Jeonbuk National University Hospital
        • Contact:
          • Study Coordinator
    • Seoul
      • Seoul, Seoul, South Korea, 03312
        • The Catholic University of Korea Eunpyeong St. Mary's Hospital
        • Contact:
          • Study Coordinator
      • Seoul, Seoul, South Korea
        • Chung-Ang University Hospital
        • Contact:
          • Study Coordinator
      • Seoul, Seoul, South Korea
        • Ewha Womans University Seoul Hospital
        • Contact:
          • Study Coordinator

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CVI-VZV-001 Low Dose
Participants 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.
Biological: CVI-VZV-001
Investigational herpes zoster vaccine.
Experimental: CVI-VZV-001 High Dose
Participants 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.
Biological: CVI-VZV-001
Investigational herpes zoster vaccine.
Active Comparator: Shingrix
Participants receive two doses of the licensed herpes zoster vaccine Shingrix administered intramuscularly on Day 0 and Week 8.
Biological: Shingrix
Licensed herpes zoster vaccine used as an active comparator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody
Time Frame: 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.
Baseline to 4 weeks after the second vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody at Additional Time Points
Time Frame: Before the second vaccination and at 8 and 24 weeks after the second vaccination
Geometric mean fold rise (GMFR) of anti-VZV glycoprotein E (gE) antibody levels measured by ELISA relative to baseline.
Before the second vaccination and at 8 and 24 weeks after the second vaccination
Geometric Mean Concentration (GMC) of Anti-VZV gE Antibody
Time Frame: Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Geometric mean concentration (GMC) of anti-VZV glycoprotein E (gE) antibody levels measured by ELISA.
Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Vaccine Response Rate (VRR) of Anti-VZV gE Antibody
Time Frame: Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Proportion of participants achieving a predefined vaccine response in anti-VZV glycoprotein E (gE) antibody levels measured by ELISA.
Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Polyfunctional CD4+ T Cell Response
Time Frame: 4 and 8 weeks after the second vaccination
Frequency of polyfunctional CD4+ T cells defined as CD4+ T cells producing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L [CD154]) following stimulation with VZV glycoprotein E peptides.
4 and 8 weeks after the second vaccination
Geometric Mean Concentration (GMC) of Anti-VZV Antibody
Time Frame: Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination
Geometric mean concentration (GMC) of anti-varicella-zoster virus (VZV) antibodies measured by ELISA.
Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHA Vaccine Institute Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVI-VZV-001-CT2501-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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