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

A Multi-center, Randomized, Double Blinded, Parallel-group 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 646 healthy subjects 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: Herpes Zoster
• Intervention / Treatment: Biological: NBP608; Biological: Zostavax

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 646 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned to low, high potency of NBP608 group and Zostavax group in 1:1:2 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.

Total of six visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks, 52 weeks after vaccination at Visit 2, Visit 4, Visit 6 respectively. Safety is monitored 1 week, 6 weeks, 26 weeks and 52 weeks after vaccination through Visit 3*, Visit 4, Visit 5*, Visit 6. (* telephone contact)

• Study Type: Interventional
• Enrollment (Actual): 675
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Guro-gu
    • Seoul, Guro-gu, Korea, Republic of, 08308
      • Korea University Guro Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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 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 screening visit
• Those who have received other IPs(Investigational Products) in another clinical study witin 4 weeks prior to IP vaccination in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low potency of NBP608; Single dose 0.5mL of low potency 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
Experimental: High potency of NBP608; Single dose 0.5mL of high potency 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 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)	The geometric mean fold rise of subjects' VZV antibody titers of NBP608 from prevaccination to 6 weeks after vaccination	6 weeks after IP(Investigational Product) vaccination
GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)	Non-inferiority assessment by comparing GMR of NBP608 to Zostavax	6 weeks after IP(Investigational Product) vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Immune response measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)	52 weeks after IP(Investigational Product) vaccination
Immune response measured by IFN-γ ELISPOT(Interferon-gamma Enzyme-Linked Immunospot)	6 weeks after IP(Investigational Product) vaccination
Immune response measured by IFN-γ ELISPOT(Interferon-gamma Enzyme-Linked Immunospot)	52 weeks after IP(Investigational Product) vaccination
Immune response measured by FAMA(Fluorescent Antibody to Membrane Antigen)	6 weeks after IP(Investigational Product) vaccination
Immune response measured by FAMA(Fluorescent Antibody to Membrane Antigen)	52 weeks after IP(Investigational Product) vaccination

Collaborators and Investigators

• Sponsor: SK Chemicals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2014
• Primary Completion (Actual): April 8, 2014
• Study Completion (Actual): March 7, 2015

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Prevention of Herpes Zoster; Herpes Zoster Vaccine
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster
• Other Study ID Numbers: NBP608_HZ_III_2013

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