Safety Study of NBP608 in Healthy Adult Volunteers
An Open Label, Active Controlled, Parallel Group Phase I Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP608 in Healthy Adult Volunteers
1 other identifier
interventional
150
1 country
1
Brief Summary
- Indication: Protection against varicella and herpes zoster
- Study Objectives
- Primary: Safety and tolerability assessment after single dose administration of NBP608
- Secondary: immunogenicity assessment after single dose administration of NBP608
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2012
Shorter than P25 for phase_1
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
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedApril 20, 2017
April 1, 2017
3 months
April 17, 2017
April 19, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence Rate of Adverse Event
42days after Investigation Product Vaccination
Secondary Outcomes (2)
Varicella Zoster Virus Antibody Titer Measured by FAMA(Fluorescent Antibody to Membrane Antigen)
42days after Investigation Product Vaccination
Varicella Zoster Virus Antibody Titer Measured by gpELISA(Glycoprotein Enzyme-Linked Immunosorbent Assay)
42days after Investigation Product Vaccination
Study Arms (5)
VARIVAX
ACTIVE COMPARATORSingle dose 0.5mL of Varivax 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
NBP6081
EXPERIMENTALSingle dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
NBP6082
EXPERIMENTALSingle dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
NBP6083
EXPERIMENTALSingle dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Interventions
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
Eligibility Criteria
You may qualify if:
- Healthy adults aged 20 and over
- Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements
- Female subjects of post-menopausal (amenorrhea for 24 months) whose pregnancy tests was found negative at screening visit
- Subjects of seropositive for Varicella-Zoster virus at screening visit
You may not qualify if:
- Patients with herpes zoster
- Subjects with a history of vaccination for herpes zoster
- Pregnant or lactating women
- Participants in another clinical study within 4 weeks before vaccination in this study, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Guro Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee-jin Cheong
Korea University Guro Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2017
First Posted
April 20, 2017
Study Start
November 1, 2012
Primary Completion
February 1, 2013
Study Completion
March 1, 2013
Last Updated
April 20, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share