Safety Study of NBP608 in Healthy Adult Volunteers

An Open Label, Active Controlled, Parallel Group Phase I Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP608 in Healthy Adult Volunteers

• 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) .

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.