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Completed

NCT Number: NCT03121638

Safety Study of NBP608 in Healthy Adult Volunteers

* Indication: Protection against varicella and herpes zoster * Study Objectives

* Primary: Safety and tolerability assessment after single dose administration of NBP608 * Secondary: immunogenicity assessment after single dose administration of NBP608

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Key information

Conditions

Varicella Zoster Immunization; Infection Infections

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Korea University Guro Hospital

Seoul, South Korea

About this study

This is a single-center, open label, active controlled, dose-escalation, parallel group study to assess the safety, tolerability and immunogenicity of NBP608 in healthy adult volunteers. Total of 150 healthy subjects aged 20 and over are enrolled, and each subject is administered with single dose of vaccine which is sequentially assigned to active group 1, 2 and study group 1~3 in 1:1:1:1:1 ratio(30 subjects are enrolled at each groups) .

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy adults aged 20 and over
  • Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements
  • Female subjects of post-menopausal (amenorrhea for 24 months) whose pregnancy tests was found negative at screening visit
  • Subjects of seropositive for Varicella-Zoster virus at screening visit

Exclusion criteria

  • Patients with herpes zoster
  • Subjects with a history of vaccination for herpes zoster
  • Pregnant or lactating women
  • Participants in another clinical study within 4 weeks before vaccination in this study, etc.

Treatment and study plan

Varivax

Biological

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

Zostavax

Biological

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

NBP6081

Biological

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

NBP6082

Biological

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

NBP6083

Biological

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

Primary outcomes

  1. Incidence Rate of Adverse Event

    Time frame: 42days after Investigation Product Vaccination

Secondary outcomes

  1. Varicella Zoster Virus Antibody Titer Measured by FAMA(Fluorescent Antibody to Membrane Antigen)

    Time frame: 42days after Investigation Product Vaccination

  2. Varicella Zoster Virus Antibody Titer Measured by gpELISA(Glycoprotein Enzyme-Linked Immunosorbent Assay)

    Time frame: 42days after Investigation Product Vaccination

Sponsors and collaborators

Lead sponsor

SK Chemicals Co., Ltd.

Industry

Registry information

Official study title

An Open Label, Active Controlled, Parallel Group Phase I Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP608 in Healthy Adult Volunteers

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 20, 2017
Registry last updated
Apr 20, 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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