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

Herpes Zoster Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120364
• Other study ID #: NBP608_HZ_III_2015
• Status: Completed
• Phase: Phase 3
• First received: April 12, 2017
• Last updated: April 17, 2017
• Start date: September 9, 2015
• Est. completion date: April 28, 2016

Study information

• Verified date: April 2017
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 824
• Est. completion date: April 28, 2016
• Est. primary completion date: December 16, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• NBP608
Preparation of Oka/SK strain of live, attenuated zoster virus
• Zostavax
Preparation of Oka/Merck strain of live, attenuated zoster virus

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul	Guro-gu

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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(Varicella zoster virus) antibody titers of NBP608 from prevaccination to 6weeks postvaccination	6 weeks after IP(Investigational Product) vaccination
Primary	GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA	Non-inferiority assessment by comparing GMR(Geometric Mean Ratio) of NBP608 to Zostavax	6 weeks after IP(Investigational Product) vaccination
Secondary	VZV-CMI(Varicella Zoster Virus-Cell Mediated Immnogenicity) response measured by IFN-?(Interferon-gamma) ELISPOT (Enzyme-Linked Immunospot)		6 weeks after IP(Investigational Product) vaccination
Secondary	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