Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over

Study Overview
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Brief Summary
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This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay). Total of 824 healthy subjects (412 subjects per treatment arm) aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

Detailed Description
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This is a multi-center, randomized, double blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to Zostavax which are indicated for the prevention of herpes zoster. Total of 824 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata. Total of five visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 2 and Visit 4 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 3*, Visit 4 and Visit 5* (* telephone contact)

Official Title
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A Randomized, Double Blinded, Multi-center Phase III Confirmatory Study to Assess the Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over

Conditions
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Herpes Zoster

Intervention / Treatment
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* Biological: NBP608
* Biological: Zostavax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult over aged 50 years Menopause females or females who are confirmed to be negative in a preganacy test on the day of screening and agree to practice birth control for 6 weeks after signing informed concent Exclusion Criteria: Those with hypersensitivity to any component of IP(Investigational Product), such as gelatin Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome Those who have received antiviral agents witin 1 month prior to IP vaccination (topical antiviral agent is allowed) Those who have previously received herpes zoster vaccine Those who have a history of herpes zoster Those with congenital or acquired immunodeficiency Those with active untreated tuberculosis Those who have received blood products or immunoglobulin within 3 months prior to IP(Investigational Products) vaccination Those who have received other IPs(Investigational Products) in another clinical study witin 4 weeks prior to IP vaccination in this study

Ages Eligible for Study
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Minimum Age: 50 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBP608<br>Single dose 0.5mL of NBP608 by subcutaneous injection into the outer aspect of the upper arm | Biological: NBP608<br>* Preparation of Oka/SK strain of live, attenuated 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 zoster virus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay) | The geometric mean fold rise of subjects' VZV(Varicella zoster virus) antibody titers of NBP608 from prevaccination to 6weeks postvaccination | 6 weeks after IP(Investigational Product) vaccination | 
| GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA | Non-inferiority assessment by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax | 6 weeks after IP(Investigational Product) vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IFN-γ(Interferon-gamma) ELISPOT (Enzyme-Linked Immunospot) |  | 6 weeks after IP(Investigational Product) vaccination | 
| VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IL-2(Interleukin-2) ELISPOT (Enzyme-Linked Immunospot) |  | 6 weeks after IP(Investigational Product) vaccination | 

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