Safety Study of NBP608 in Healthy Adult Volunteers

Study Overview
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Brief Summary
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Indication: Protection against varicella and herpes zoster Study Objectives Primary: Safety and tolerability assessment after single dose administration of NBP608 Secondary: immunogenicity assessment after single dose administration of NBP608

Detailed Description
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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) .

Official Title
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An Open Label, Active Controlled, Parallel Group Phase I Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP608 in Healthy Adult Volunteers

Conditions
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Varicella Zoster, Immunization; Infection

Intervention / Treatment
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* Biological: VARIVAX
* Biological: ZOSTAVAX
* Biological: NBP6081
* Biological: NBP6082
* Biological: NBP6083


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adults aged 20 and over Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements Female subjects of post-menopausal (amenorrhea for 24 months) whose pregnancy tests was found negative at screening visit Subjects of seropositive for Varicella-Zoster virus at screening visit Exclusion Criteria: Patients with herpes zoster Subjects with a history of vaccination for herpes zoster Pregnant or lactating women Participants in another clinical study within 4 weeks before vaccination in this study, etc.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VARIVAX<br>Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm | Biological: VARIVAX<br>* Preparation of Oka/Merck strain of live, attenuated varicella zoster virus<br>|
| Active Comparator: ZOSTAVAX<br>Single dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm | Biological: ZOSTAVAX<br>* Preparation of Oka/Merck strain of live, attenuated varicella zoster virus<br>|
| Experimental: NBP6081<br>Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm | Biological: NBP6081<br>* Preparation of Oka/SK strain of live, attenuated varicella zoster virus<br>|
| Experimental: NBP6082<br>Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm | Biological: NBP6082<br>* Preparation of Oka/SK strain of live, attenuated varicella zoster virus<br>|
| Experimental: NBP6083<br>Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm | Biological: NBP6083<br>* Preparation of Oka/SK strain of live, attenuated varicella zoster virus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Adverse Event |  | 42days after Investigation Product Vaccination | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 42days after Investigation Product Vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicella Vaccine, Herpes Zoster Vaccine