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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVI-VZV-001 Low Dose | Experimental | 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. |
|
| CVI-VZV-001 High Dose | Experimental | 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. |
|
| Shingrix | Active Comparator | Participants receive two doses of the licensed herpes zoster vaccine Shingrix administered intramuscularly on Day 0 and Week 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shingrix | Biological | Licensed herpes zoster vaccine used as an active comparator. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before the second vaccination and at 8 and 24 weeks after the second vaccination |
| Geometric Mean Concentration (GMC) of Anti-VZV gE Antibody |
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Inclusion Criteria:
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinsol Lee | Contact | +82-31-881-7716 | jsleee@chabio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Chilgok Hospital | Daegu | Daegu | South Korea |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| CVI-VZV-001 |
| Biological |
Investigational herpes zoster vaccine. |
|
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 | 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 | 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 | 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 |
| CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | South Korea |
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| Yongin Severance Hospital, Yonsei University Health System | Yongin | Gyeonggi-do | South Korea |
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| Jeonbuk National University Hospital | Jeonju | Jeollabuk-do | South Korea |
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| The Catholic University of Korea Eunpyeong St. Mary's Hospital | Seoul | Seoul | 03312 | South Korea |
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| Chung-Ang University Hospital | Seoul | Seoul | South Korea |
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| Ewha Womans University Seoul Hospital | Seoul | Seoul | South Korea |
|
| D007239 | Infections |