Safety Study of NBP608 in Healthy Adult Volunteers

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

Brief Summary

      -  Indication: Protection against varicella and herpes zoster

        -  Study Objectives

             -  Primary: Safety and tolerability assessment after single dose administration of

             -  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 Phase

Phase 1

Study Type


Primary Outcome

Incidence Rate of Adverse Event

Secondary Outcome

 Varicella Zoster Virus Antibody Titer Measured by FAMA(Fluorescent Antibody to Membrane Antigen)


Varicella Zoster



Study Arms / Comparison Groups

Description:  Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

November 2012

Completion Date

March 2013

Primary Completion Date

February 2013

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.




20 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers


Hee-jin Cheong, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

SK Chemicals Co., Ltd.

Study Sponsor

Hee-jin Cheong, Principal Investigator, Korea University Guro Hospital

Verification Date

April 2017