Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over

April 17, 2017 updated by: SK Chemicals Co., Ltd.

A Randomized, Double Blinded, Multi-center Phase III Confirmatory Study to Assess the Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over

This study assesses non-inferiority by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax which are evaluated by gpELISA (Glycoprotein Enzyme Linked Immunosorbent Assay). Total of 824 healthy subjects (412 subjects per treatment arm) aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, randomized, double blinded, parallel-group study to assess the Immunogenicity and safety of NBP608 compared to Zostavax which are indicated for the prevention of herpes zoster. Total of 824 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.

Total of five visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at Visit 2 and Visit 4 respectively. Safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through Visit 3*, Visit 4 and Visit 5* (* telephone contact)

Study Type

Interventional

Enrollment (Actual)

824

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Guro-gu
      • Seoul, Guro-gu, Korea, Republic of, 152-703
        • Korea University Guro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult over aged 50 years
  • Menopause females or females who are confirmed to be negative in a preganacy test on the day of screening and agree to practice birth control for 6 weeks after signing informed concent

Exclusion Criteria:

  • Those with hypersensitivity to any component of IP(Investigational Product), such as gelatin
  • Those with a history of hypersensitivity to vaccination, such as Guillain-Barre syndrome
  • Those who have received antiviral agents witin 1 month prior to IP vaccination (topical antiviral agent is allowed)
  • Those who have previously received herpes zoster vaccine
  • Those who have a history of herpes zoster
  • Those with congenital or acquired immunodeficiency
  • Those with active untreated tuberculosis
  • Those who have received blood products or immunoglobulin within 3 months prior to IP(Investigational Products) vaccination
  • Those who have received other IPs(Investigational Products) in another clinical study witin 4 weeks prior to IP vaccination in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NBP608
Single dose 0.5mL of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Biological: NBP608
Preparation of Oka/SK strain of live, attenuated 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 zoster virus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)
Time Frame: 6 weeks after IP(Investigational Product) vaccination
The geometric mean fold rise of subjects' VZV(Varicella zoster virus) antibody titers of NBP608 from prevaccination to 6weeks postvaccination
6 weeks after IP(Investigational Product) vaccination
GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA
Time Frame: 6 weeks after IP(Investigational Product) vaccination
Non-inferiority assessment by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax
6 weeks after IP(Investigational Product) vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IFN-γ(Interferon-gamma) ELISPOT (Enzyme-Linked Immunospot)
Time Frame: 6 weeks after IP(Investigational Product) vaccination
6 weeks after IP(Investigational Product) vaccination
VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IL-2(Interleukin-2) ELISPOT (Enzyme-Linked Immunospot)
Time Frame: 6 weeks after IP(Investigational Product) vaccination
6 weeks after IP(Investigational Product) vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SK Chemicals Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 9, 2015

Primary Completion (ACTUAL)

December 16, 2015

Study Completion (ACTUAL)

April 28, 2016

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 17, 2017

First Posted (ACTUAL)

April 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2017

Last Update Submitted That Met QC Criteria

April 17, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBP608_HZ_III_2015

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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