Safety Study of NBP608 in Healthy Adult Volunteers

SK chemicals

Status and phase: Completed; Phase 1

Conditions: Varicella Zoster; Immunization; Infection

Treatments: Biological: NBP6082; Biological: VARIVAX; Biological: ZOSTAVAX; Biological: NBP6081; Biological: NBP6083

Study type: Interventional

Funder types: Industry

Identifiers

NCT03121638

NBP608_VZ_I_2012

Details and patient eligibility

About

• 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

Full 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) .

Enrollment: 150 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 5 patient groups

VARIVAX

Active Comparator group

Description:

Single dose 0.5mL of Varivax by subcutaneous injection into the outer aspect of the upper arm

Treatment:

Biological: VARIVAX

ZOSTAVAX

Active Comparator group

Description:

Single dose 0.65mL of Zostavax by subcutaneous injection into the outer aspect of the upper arm

Treatment:

Biological: ZOSTAVAX

NBP6081

Experimental group

Description:

Single dose 0.5mL of low potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm

Treatment:

Biological: NBP6081

NBP6082

Experimental group

Description:

Single dose 0.5mL of middle potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm

Treatment:

Biological: NBP6082

NBP6083

Experimental group

Description:

Single dose 0.5mL of high potency of NBP608 by subcutaneous injection into the outer aspect of the upper arm

Treatment:

Biological: NBP6083