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
                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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence Rate of Adverse Event

Secondary Outcome

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

Condition

Varicella Zoster

Intervention

VARIVAX

Study Arms / Comparison Groups

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

Publications

* 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

Biological

Estimated Enrollment

150

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.
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Hee-jin Cheong, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT03121638

Organization ID

NBP608_VZ_I_2012


Responsible Party

Sponsor

Study Sponsor

SK Chemicals Co., Ltd.


Study Sponsor

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


Verification Date

April 2017