An Open Label, Active Controlled, Parallel Group Phase I Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP608 in Healthy Adult Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- SK Chemicals Co., Ltd.
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Incidence Rate of Adverse Event
Study Overview
Brief Summary
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Indication: Protection against varicella and herpes zoster
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Study Objectives
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Primary: Safety and tolerability assessment after single dose administration of NBP608
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Secondary: immunogenicity assessment after single dose administration of NBP608
Detailed Description
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) .
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
ZOSTAVAX
Single dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm
Intervention: ZOSTAVAX (Biological)
NBP6081
Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Intervention: NBP6081 (Biological)
NBP6082
Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Intervention: NBP6082 (Biological)
NBP6083
Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm
Intervention: NBP6083 (Biological)
VARIVAX
Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm
Intervention: VARIVAX (Biological)
Outcomes
Primary Outcomes
Incidence Rate of Adverse Event
Time Frame: 42days after Investigation Product Vaccination
Secondary Outcomes
- Varicella Zoster Virus Antibody Titer Measured by FAMA(Fluorescent Antibody to Membrane Antigen)(42days after Investigation Product Vaccination)
- Varicella Zoster Virus Antibody Titer Measured by gpELISA(Glycoprotein Enzyme-Linked Immunosorbent Assay)(42days after Investigation Product Vaccination)