Herpes Zoster
Conditions
Keywords
Herpes Zoster Vaccine, Shingles, Varicella Zoster Virus, Immunogenicity
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.
Interventions
BIOLOGICALShingrix
Licensed herpes zoster vaccine used as an active comparator.
BIOLOGICALCVI-VZV-001
Investigational herpes zoster vaccine.
Sponsors
CHA Vaccine Institute Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 fold rise (GMFR) of anti-VZV glycoprotein E (gE) antibody levels measured by ELISA relative to baseline. |
| Geometric Mean Concentration (GMC) of Anti-VZV gE Antibody | 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. |
| Vaccine Response Rate (VRR) of Anti-VZV gE Antibody | 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. |
| Polyfunctional CD4+ T Cell Response | 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. |
| Geometric Mean Concentration (GMC) of Anti-VZV Antibody | 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. |
Countries
South Korea
Contacts
CONTACTJinsol Lee
Outcome results
None listed