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Immunogenicity and Safety of Two Lots of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over

Primary Purpose

Herpes Zoster

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
NBP608
Zostavax
Sponsored by
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster focused on measuring Herpes Zoster Vaccine, Prevention of Herpes Zoster

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 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

Sites / Locations

  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Low potency of NBP608

High potency of NBP608

Zostavax

Arm Description

Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm

Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm

Single dose 0.65mL 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 antibody titers of NBP608 from prevaccination to 6 weeks after 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

Secondary Outcome Measures

Immune response measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)
Immune response measured by IFN-γ ELISPOT(Interferon-gamma Enzyme-Linked Immunospot)
Immune response measured by IFN-γ ELISPOT(Interferon-gamma Enzyme-Linked Immunospot)
Immune response measured by FAMA(Fluorescent Antibody to Membrane Antigen)
Immune response measured by FAMA(Fluorescent Antibody to Membrane Antigen)

Full Information

First Posted
April 12, 2017
Last Updated
April 12, 2017
Sponsor
SK Chemicals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03116594
Brief Title
Immunogenicity and Safety of Two Lots of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 3, 2014 (Actual)
Primary Completion Date
April 8, 2014 (Actual)
Study Completion Date
March 7, 2015 (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 646 healthy subjects 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 646 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned to low, high potency of NBP608 group and Zostavax group in 1:1:2 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata. Total of six visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks, 52 weeks after vaccination at Visit 2, Visit 4, Visit 6 respectively. Safety is monitored 1 week, 6 weeks, 26 weeks and 52 weeks after vaccination through Visit 3*, Visit 4, Visit 5*, Visit 6. (* 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 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
675 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low potency of NBP608
Arm Type
Experimental
Arm Description
Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Arm Title
High potency of NBP608
Arm Type
Experimental
Arm Description
Single dose 0.5mL of high potency 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 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 antibody titers of NBP608 from prevaccination to 6 weeks after vaccination
Time Frame
6 weeks after IP(Investigational Product) vaccination
Title
GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)
Description
Non-inferiority assessment by comparing GMR of NBP608 to Zostavax
Time Frame
6 weeks after IP(Investigational Product) vaccination
Secondary Outcome Measure Information:
Title
Immune response measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)
Time Frame
52 weeks after IP(Investigational Product) vaccination
Title
Immune response measured by IFN-γ ELISPOT(Interferon-gamma Enzyme-Linked Immunospot)
Time Frame
6 weeks after IP(Investigational Product) vaccination
Title
Immune response measured by IFN-γ ELISPOT(Interferon-gamma Enzyme-Linked Immunospot)
Time Frame
52 weeks after IP(Investigational Product) vaccination
Title
Immune response measured by FAMA(Fluorescent Antibody to Membrane Antigen)
Time Frame
6 weeks after IP(Investigational Product) vaccination
Title
Immune response measured by FAMA(Fluorescent Antibody to Membrane Antigen)
Time Frame
52 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 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
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
08308
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Immunogenicity and Safety of Two Lots of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over

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