Immunogenicity and Safety of Two Lots of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
A Multi-center, Randomized, Double Blinded, Parallel-group Study to Assess the Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
1 other identifier
interventional
675
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 646 healthy subjects 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_2
Started Jan 2014
Shorter than P25 for phase_2
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
January 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2015
CompletedFirst Submitted
Initial submission to the registry
April 12, 2017
CompletedFirst Posted
Study publicly available on registry
April 17, 2017
CompletedApril 17, 2017
April 1, 2017
3 months
April 12, 2017
April 12, 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 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
Secondary Outcomes (5)
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
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
Study Arms (3)
Low potency of NBP608
EXPERIMENTALSingle dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
High potency of NBP608
EXPERIMENTALSingle dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Zostavax
ACTIVE COMPARATORSingle dose 0.65mL 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 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 screening visit
- 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, 08308, South Korea
Related Publications (1)
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: 37781954DERIVED
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 2
- 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 17, 2017
Study Start
January 3, 2014
Primary Completion
April 8, 2014
Study Completion
March 7, 2015
Last Updated
April 17, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share