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

Phase 3

Completed

• Conditions: Herpes Zoster
• Interventions: Biological: NBP608; Biological: Zostavax

• Registration Number: NCT03120364
• Lead Sponsor: SK Chemicals Co., Ltd.

Brief Summary

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.

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 Timeline

• Study Start: 2015-09-09
• Primary Completion: 2015-12-16
• Study Completion: 2016-04-28
• Status Verified: 2017-04
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-17
• Last Update Submitted: 2017-04-17
• Study First Posted: 2017-04-19
• Last Update Posted: 2017-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 824

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBP608	NBP608	Single dose 0.5mL 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

Primary Outcome Measures

Name	Time	Method
GMR(Geometric Mean Ratio) of VZV(Varicella-Zoster Virus) antibody titer measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)	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
GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA	6 weeks after IP(Investigational Product) vaccination	Non-inferiority assessment by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax

Secondary Outcome Measures

Name	Time	Method
VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IFN-γ(Interferon-gamma) ELISPOT (Enzyme-Linked Immunospot)	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)	6 weeks after IP(Investigational Product) vaccination

Trial Locations

Locations (1)

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