Safety Study of NBP608 in Healthy Adult Volunteers

Phase 1

Completed

• Conditions: Varicella Zoster; Immunization; Infection
• Interventions: Biological: NBP6081; Biological: ZOSTAVAX; Biological: NBP6082; Biological: NBP6083; Biological: VARIVAX

• Registration Number: NCT03121638
• Lead Sponsor: SK Chemicals Co., Ltd.

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) .

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Status Verified: 2017-04
• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-04-19
• Last Update Submitted: 2017-04-19
• Study First Posted: 2017-04-20
• Last Update Posted: 2017-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBP6081	NBP6081	Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
ZOSTAVAX	ZOSTAVAX	Single dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm
NBP6082	NBP6082	Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
NBP6083	NBP6083	Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
VARIVAX	VARIVAX	Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Adverse Event	42days after Investigation Product Vaccination

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of