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

• 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

Study Overview

• Status: Completed
• Conditions: Immunization; Infection; Varicella Zoster
• Intervention / Treatment: Biological: VARIVAX; Biological: ZOSTAVAX; Biological: NBP6081; Biological: NBP6082; Biological: NBP6083

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) .

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VARIVAX; Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm	Biological: VARIVAX; Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
Active Comparator: ZOSTAVAX; Single dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm	Biological: ZOSTAVAX; Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
Experimental: NBP6081; Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm	Biological: NBP6081; Preparation of Oka/SK strain of live, attenuated varicella zoster virus
Experimental: NBP6082; Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm	Biological: NBP6082; Preparation of Oka/SK strain of live, attenuated varicella zoster virus
Experimental: NBP6083; Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm	Biological: NBP6083; Preparation of Oka/SK strain of live, attenuated varicella zoster virus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence Rate of Adverse Event	42days after Investigation Product Vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.
• Investigators: Principal Investigator: Hee-jin Cheong, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Herpes Zoster Vaccine; Varicella Vaccine
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Chickenpox
• Other Study ID Numbers: NBP608_VZ_I_2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No