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NCT Number: NCT07481604

Safety and Immunogenicity of CVI-VZV-001 in 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.

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Key information

Conditions

Herpes Zoster Chickenpox DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kyungpook National University Chilgok Hospital, Daegu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shingrix

Biological

Licensed herpes zoster vaccine used as an active comparator.

CVI-VZV-001

Biological

Investigational herpes zoster vaccine.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jinsol Lee

CONTACT

[email protected]

+82-31-881-7716

Sponsors and collaborators

Lead sponsor

Aribio Lab Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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