NCT02693652

A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine

A Single Center, Open Labeled Phase I/IIa Study to Evaluate Safety, Tolerability and Efficacy of a Therapeutic Hepatitis B Vaccine in Oral Antiviral Drug-treated Chronic Hepatitis B Virus Carriers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: CHA Vaccine Institute Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A single center, open labeled phase I/IIa study to evaluate safety, tolerability and efficacy of a therapeutic hepatitis B vaccine in oral antiviral drug-treated chronic hepatitis B virus carriers

Detailed description

* Objectives: To explore the appropriate dose of a therapeutic hepatitis B vaccine through the evaluation of safety, tolerability, and efficacy * Subjects: Chronic hepatitis B carrier with normal ALT range * Study hypothesis: The immune tolerance break and strong immune responses in the chronic hepatitis B carrier could be achieved with therapeutic hepatitis B vaccine containing novel adjuvant

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	CVI-HBV-002	* Investigational product: CVI-HBV-002 * Dose: 20ug or 40ug * Frequency: 3 or 6 times * Vaccination schedule: 0, 1, 2 months or 0, 1, 2, 3, 4, 5 months * Administration route: Intramuscular injection

Timeline

• Start date: 2014-10-28
• Primary completion: 2017-08-22
• Completion: 2017-08-22
• First posted: 2016-02-29
• Last updated: 2023-11-18

Locations

1 site across 1 country: South Korea