Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
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
1 other identifier
interventional
824
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2016
CompletedFirst Submitted
Initial submission to the registry
April 12, 2017
CompletedFirst Posted
Study publicly available on registry
April 19, 2017
CompletedApril 19, 2017
April 1, 2017
3 months
April 12, 2017
April 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
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
Study Arms (2)
NBP608
EXPERIMENTALSingle dose 0.5mL of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Zostavax
ACTIVE COMPARATORSingle dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Guro Hospital
Seoul, Guro-gu, 152-703, South Korea
Related Publications (2)
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.
PMID: 37781954DERIVEDChoi 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.
PMID: 31122860DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee-Jin Cheong, Ph.D
Korea University Guro Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2017
First Posted
April 19, 2017
Study Start
September 9, 2015
Primary Completion
December 16, 2015
Study Completion
April 28, 2016
Last Updated
April 19, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share