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Indication: Protection against varicella and herpes zoster
Study Objectives
This is a single-center, open label, active controlled, dose-escalation, parallel group study to assess the safety, tolerability and immunogenicity of NBP608 in healthy adult volunteers. Total of 150 healthy subjects aged 20 and over are enrolled, and each subject is administered with single dose of vaccine which is sequentially assigned to active group 1, 2 and study group 1~3 in 1:1:1:1:1 ratio(30 subjects are enrolled at each groups) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VARIVAX | Active Comparator | Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm |
|
| ZOSTAVAX | Active Comparator | Single dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm |
|
| NBP6081 | Experimental | Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm |
|
| NBP6082 | Experimental | Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm |
|
| NBP6083 | Experimental | Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VARIVAX | Biological | Preparation of Oka/Merck strain of live, attenuated varicella zoster virus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Adverse Event | 42days after Investigation Product Vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Varicella Zoster Virus Antibody Titer Measured by FAMA(Fluorescent Antibody to Membrane Antigen) | 42days after Investigation Product Vaccination | |
| Varicella Zoster Virus Antibody Titer Measured by gpELISA(Glycoprotein Enzyme-Linked Immunosorbent Assay) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee-jin Cheong | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| ZOSTAVAX | Biological | Preparation of Oka/Merck strain of live, attenuated varicella zoster virus |
|
| NBP6081 | Biological | Preparation of Oka/SK strain of live, attenuated varicella zoster virus |
|
| NBP6082 | Biological | Preparation of Oka/SK strain of live, attenuated varicella zoster virus |
|
| NBP6083 | Biological | Preparation of Oka/SK strain of live, attenuated varicella zoster virus |
|
| 42days after Investigation Product Vaccination |
| D045424 |
| Complex Mixtures |