A Multi-center, Randomized, Double Blinded, Parallel-group Study to Assess the Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- SK Chemicals Co., Ltd.
- Enrollment
- 675
- Locations
- 2
- Primary Endpoint
- GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)
Study Overview
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 646 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.
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 646 healthy subjects aged 50 and over are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned to low, high potency of NBP608 group and Zostavax group in 1:1:2 ratio. Stratified randomization for age group is used to achieve the balance of treatment assignment within age strata.
Total of six visits are scheduled including two visits via telephone contact. Blood sampling is conducted for immunogenicity assessment before and 6 weeks, 52 weeks after vaccination at Visit 2, Visit 4, Visit 6 respectively. Safety is monitored 1 week, 6 weeks, 26 weeks and 52 weeks after vaccination through Visit 3*, Visit 4, Visit 5*, Visit 6. (* telephone contact)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 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 screening visit
- •Those who have received other IPs(Investigational Products) in another clinical study witin 4 weeks prior to IP vaccination in this study
Outcomes
Primary Outcomes
GMR(Geometric Mean Ratio) ratio of NBP608 to Zostavax measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)
Time Frame: 6 weeks after IP(Investigational Product) vaccination
Non-inferiority assessment by comparing GMR of NBP608 to Zostavax
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 antibody titers of NBP608 from prevaccination to 6 weeks after vaccination
Secondary Outcomes
- Immune response measured by FAMA(Fluorescent Antibody to Membrane Antigen)(52 weeks after IP(Investigational Product) vaccination)
- Immune response measured by gpELISA(Glycoprotein Enzyme-Linked Immnosorbent Assay)(52 weeks after IP(Investigational Product) vaccination)
- Immune response measured by IFN-γ ELISPOT(Interferon-gamma Enzyme-Linked Immunospot)(52 weeks after IP(Investigational Product) vaccination)