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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 646 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.
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 646 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned to low, high potency of NBP608 group and Zostavax group in 1:1:2 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.
Total of six visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks, 52 weeks after vaccination at Visit 2, Visit 4, Visit 6 respectively. Safety is monitored 1 week, 6 weeks, 26 weeks and 52 weeks after vaccination through Visit 3*, Visit 4, Visit 5*, Visit 6. (* telephone contact)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low potency of NBP608 | Experimental | Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm |
|
| High potency of NBP608 | Experimental | Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm |
|
| Zostavax | Active Comparator | Single dose 0.65mL Zostavax by subcutaneous injection into the outer aspect of the upper arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBP608 | Biological | Preparation of Oka/SK strain of live, attenuated zoster virus |
|
| 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 antibody titers of NBP608 from prevaccination to 6 weeks after vaccination | 6 weeks after IP(Investigational Product) vaccination |
| GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay) | Non-inferiority assessment by comparing GMR of NBP608 to Zostavax | 6 weeks after IP(Investigational Product) vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay) | 52 weeks after IP(Investigational Product) vaccination | |
| Immune response measured by IFN-γ ELISPOT(Interferon-gamma Enzyme-Linked Immunospot) | 6 weeks after IP(Investigational Product) vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee-Jin Cheong, Ph.D | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Seoul | Guro-gu | 08308 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37781954 | Derived | de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5. |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
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| Zostavax | Biological | Preparation of Oka/Merck strain of live, attenuated zoster virus |
|
| Immune response measured by IFN-γ ELISPOT(Interferon-gamma Enzyme-Linked Immunospot) | 52 weeks after IP(Investigational Product) vaccination |
| Immune response measured by FAMA(Fluorescent Antibody to Membrane Antigen) | 6 weeks after IP(Investigational Product) vaccination |
| Immune response measured by FAMA(Fluorescent Antibody to Membrane Antigen) | 52 weeks after IP(Investigational Product) vaccination |
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |