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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03120364
Recruitment Status : Completed
First Posted : April 19, 2017
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Biological: NBP608 Biological: Zostavax Phase 3

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)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 824 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : September 9, 2015
Actual Primary Completion Date : December 16, 2015
Actual Study Completion Date : April 28, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120364


Locations
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Korea, Republic of
Korea University Guro Hospital
Seoul, Guro-gu, Korea, Republic of, 152-703
Sponsors and Collaborators
SK Chemicals Co., Ltd.
Investigators
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Principal Investigator: Hee-Jin Cheong, Ph.D Korea University Guro Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SK Chemicals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03120364     History of Changes
Other Study ID Numbers: NBP608_HZ_III_2015
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SK Chemicals Co., Ltd.:
Herpes Zoster Vaccine
Prevention of Herpes Zoster
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases