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Safety Study of NBP608 in Healthy Adult Volunteers

Primary Purpose

Varicella Zoster, Immunization; Infection

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
VARIVAX
ZOSTAVAX
NBP6081
NBP6082
NBP6083
Sponsored by
SK Chemicals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Korea University Guro Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Arm Label

VARIVAX

ZOSTAVAX

NBP6081

NBP6082

NBP6083

Arm Description

Single dose 0.5mL of Varivax 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

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 middle 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

Outcomes

Primary Outcome Measures

Incidence Rate of Adverse Event

Secondary Outcome Measures

Varicella Zoster Virus Antibody Titer Measured by FAMA(Fluorescent Antibody to Membrane Antigen)
Varicella Zoster Virus Antibody Titer Measured by gpELISA(Glycoprotein Enzyme-Linked Immunosorbent Assay)

Full Information

First Posted
April 17, 2017
Last Updated
April 19, 2017
Sponsor
SK Chemicals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03121638
Brief Title
Safety Study of NBP608 in Healthy Adult Volunteers
Official Title
An Open Label, Active Controlled, Parallel Group Phase I Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP608 in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
March 2013 (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
Yes

5. Study Description

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
Detailed Description
This is a single-center, open label, active controlled, dose-escalation, parallel group study to assess the safety, tolerability and immunogenicity of NBP608 in healthy adult volunteers. Total of 150 healthy subjects aged 20 and over are enrolled, and each subject is administered with single dose of vaccine which is sequentially assigned to active group 1, 2 and study group 1~3 in 1:1:1:1:1 ratio(30 subjects are enrolled at each groups) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella Zoster, Immunization; Infection
Keywords
Varicella Vaccine, Herpes Zoster Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VARIVAX
Arm Type
Active Comparator
Arm Description
Single dose 0.5mL of Varivax 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
Arm Title
NBP6081
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
NBP6082
Arm Type
Experimental
Arm Description
Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Arm Title
NBP6083
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
Intervention Type
Biological
Intervention Name(s)
VARIVAX
Intervention Description
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
Intervention Type
Biological
Intervention Name(s)
ZOSTAVAX
Intervention Description
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
Intervention Type
Biological
Intervention Name(s)
NBP6081
Intervention Description
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
Intervention Type
Biological
Intervention Name(s)
NBP6082
Intervention Description
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
Intervention Type
Biological
Intervention Name(s)
NBP6083
Intervention Description
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
Primary Outcome Measure Information:
Title
Incidence Rate of Adverse Event
Time Frame
42days after Investigation Product Vaccination
Secondary Outcome Measure Information:
Title
Varicella Zoster Virus Antibody Titer Measured by FAMA(Fluorescent Antibody to Membrane Antigen)
Time Frame
42days after Investigation Product Vaccination
Title
Varicella Zoster Virus Antibody Titer Measured by gpELISA(Glycoprotein Enzyme-Linked Immunosorbent Assay)
Time Frame
42days after Investigation Product Vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-jin Cheong
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety Study of NBP608 in Healthy Adult Volunteers

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