Back to resultsImmunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
Primary Purpose
Herpes Zoster
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NBP608
Zostavax
Sponsored by
About this trial
This is an interventional prevention trial for Herpes Zoster focused on measuring Herpes Zoster Vaccine, Prevention of Herpes Zoster
Eligibility Criteria
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
Sites / Locations
- Korea University Guro Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NBP608
Zostavax
Arm Description
Single dose 0.5mL of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Single dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IFN-γ(Interferon-gamma) ELISPOT (Enzyme-Linked Immunospot)
VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IL-2(Interleukin-2) ELISPOT (Enzyme-Linked Immunospot)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03120364
Brief Title
Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 9, 2015 (Actual)
Primary Completion Date
December 16, 2015 (Actual)
Study Completion Date
April 28, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Chemicals Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
Herpes Zoster Vaccine, Prevention of Herpes Zoster
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
824 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NBP608
Arm Type
Experimental
Arm Description
Single dose 0.5mL of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Arm Title
Zostavax
Arm Type
Active Comparator
Arm Description
Single dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm
Intervention Type
Biological
Intervention Name(s)
NBP608
Intervention Description
Preparation of Oka/SK strain of live, attenuated zoster virus
Intervention Type
Biological
Intervention Name(s)
Zostavax
Intervention Description
Preparation of Oka/Merck strain of live, attenuated zoster virus
Primary Outcome Measure Information:
Title
GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)
Description
The geometric mean fold rise of subjects' VZV(Varicella zoster virus) antibody titers of NBP608 from prevaccination to 6weeks postvaccination
Time Frame
6 weeks after IP(Investigational Product) vaccination
Title
GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA
Description
Non-inferiority assessment by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax
Time Frame
6 weeks after IP(Investigational Product) vaccination
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Jin Cheong, Ph.D
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Guro-gu
ZIP/Postal Code
152-703
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31122860
Citation
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.
Results Reference
derived
Learn more about this trial
Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
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