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NCT Number: NCT03120364

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.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Guro Hospital

Seoul, Guro-gu, 152-703, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NBP608

Biological

Preparation of Oka/SK strain of live, attenuated zoster virus

Zostavax

Biological

Preparation of Oka/Merck strain of live, attenuated zoster virus

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 19, 2017
Registry last updated
Apr 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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