Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
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ClinicalTrials.gov Identifier: NCT03120364 |
Recruitment Status :
Completed
First Posted : April 19, 2017
Last Update Posted : April 19, 2017
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Condition or disease | Intervention/treatment | Phase |
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Herpes Zoster | Biological: NBP608 Biological: Zostavax | Phase 3 |
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)
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 824 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Actual Study Start Date : | September 9, 2015 |
Actual Primary Completion Date : | December 16, 2015 |
Actual Study Completion Date : | April 28, 2016 |

Arm | Intervention/treatment |
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Experimental: NBP608
Single dose 0.5mL of NBP608 by subcutaneous injection into the outer aspect of the upper arm
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Biological: NBP608
Preparation of Oka/SK strain of live, attenuated zoster virus |
Active Comparator: Zostavax
Single dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm
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Biological: Zostavax
Preparation of Oka/Merck strain of live, attenuated zoster virus |
- GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay) [ Time Frame: 6 weeks after IP(Investigational Product) vaccination ]The geometric mean fold rise of subjects' VZV(Varicella zoster virus) antibody titers of NBP608 from prevaccination to 6weeks postvaccination
- GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA [ Time Frame: 6 weeks after IP(Investigational Product) vaccination ]Non-inferiority assessment by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax
- VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IFN-γ(Interferon-gamma) ELISPOT (Enzyme-Linked Immunospot) [ Time Frame: 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) [ Time Frame: 6 weeks after IP(Investigational Product) vaccination ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120364
Korea, Republic of | |
Korea University Guro Hospital | |
Seoul, Guro-gu, Korea, Republic of, 152-703 |
Principal Investigator: | Hee-Jin Cheong, Ph.D | Korea University Guro Hospital |
Responsible Party: | SK Chemicals Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03120364 |
Other Study ID Numbers: |
NBP608_HZ_III_2015 |
First Posted: | April 19, 2017 Key Record Dates |
Last Update Posted: | April 19, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Herpes Zoster Vaccine Prevention of Herpes Zoster |
Herpes Zoster Herpesviridae Infections DNA Virus Infections |
Virus Diseases Infections Varicella Zoster Virus Infection |