Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBP608 | Experimental | Single dose 0.5mL of NBP608 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 |
|
| 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(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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 152-703 | 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. | |
| 31122860 | Derived | Choi WS, Choi JH, Jung DS, Choi HJ, Kim YS, Lee J, Jang HC, Shin EC, Park JS, Kim H, Cheong HJ. Immunogenicity and safety of a new live attenuated herpes zoster vaccine (NBP608) compared to Zostavax(R) in healthy adults aged 50 years and older. Vaccine. 2019 Jun 12;37(27):3605-3610. doi: 10.1016/j.vaccine.2019.04.046. Epub 2019 May 20. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Zostavax |
| Biological |
Preparation of Oka/Merck strain of live, attenuated zoster virus |
|
| 6 weeks after IP(Investigational Product) vaccination |
| D007239 | Infections |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |