Safety Study of NBP608 in Healthy Adult Volunteers

SK Chemicals Co., Ltd.150 enrolled

Overview

* 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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

150

Conditions

Varicella Zoster Immunization; Infection

Interventions

VARIVAXBIOLOGICAL

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

ZOSTAVAXBIOLOGICAL

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

NBP6081BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

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)

Time frame: 42days after Investigation Product Vaccination

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

Time frame: 42days after Investigation Product Vaccination

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.