Safety Study of NBP608 in Healthy Adult Volunteers

Immunization; Infection Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121638
• Other study ID #: NBP608_VZ_I_2012
• Status: Completed
• Phase: Phase 1
• First received: April 17, 2017
• Last updated: April 19, 2017
• Start date: November 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2017
• Source: SK Chemicals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• 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

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) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Immunization; Infection
• Varicella Zoster

Intervention

Biological:
• VARIVAX
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
• ZOSTAVAX
Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
• NBP6081
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
• NBP6082
Preparation of Oka/SK strain of live, attenuated varicella zoster virus
• NBP6083
Preparation of Oka/SK strain of live, attenuated varicella zoster virus

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
SK Chemicals Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rate of Adverse Event		42days after Investigation Product Vaccination
Secondary	Varicella Zoster Virus Antibody Titer Measured by FAMA(Fluorescent Antibody to Membrane Antigen)		42days after Investigation Product Vaccination
Secondary	Varicella Zoster Virus Antibody Titer Measured by gpELISA(Glycoprotein Enzyme-Linked Immunosorbent Assay)		42days after Investigation Product Vaccination