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

Phase 2Not Yet RecruitingNCT07481604

Aribio Lab Co., Ltd.135 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

135

Conditions

Herpes Zoster

Interventions

ShingrixBIOLOGICAL

Licensed herpes zoster vaccine used as an active comparator.

CVI-VZV-001BIOLOGICAL

Investigational herpes zoster vaccine.

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (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

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 4 weeks after the second vaccination

Secondary Outcomes

Geometric Mean Fold Rise (GMFR) of Anti-VZV gE Antibody at Additional Time Points

Geometric mean fold rise (GMFR) of anti-VZV glycoprotein E (gE) antibody levels measured by ELISA relative to baseline.

Time frame: Before the second vaccination and at 8 and 24 weeks after the second vaccination

Geometric Mean Concentration (GMC) of Anti-VZV gE Antibody

Geometric mean concentration (GMC) of anti-VZV glycoprotein E (gE) antibody levels measured by ELISA.

Time frame: Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination

Vaccine Response Rate (VRR) of Anti-VZV gE Antibody

Proportion of participants achieving a predefined vaccine response in anti-VZV glycoprotein E (gE) antibody levels measured by ELISA.

Time frame: Before the second vaccination and at 4, 8, and 24 weeks after the second vaccination

Polyfunctional CD4+ T Cell Response

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.

Time frame: 4 and 8 weeks after the second vaccination

Geometric Mean Concentration (GMC) of Anti-VZV Antibody

Geometric mean concentration (GMC) of anti-varicella-zoster virus (VZV) antibodies measured by ELISA.

Central Contacts

Jinsol Lee

CONTACT

+82-31-881-7716 jsleee@chabio.com

Data from ClinicalTrials.gov

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