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

NCT02693652 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2023-11-18

No results posted yet for this study

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

Conditions

  • Hepatitis B, Chronic

Interventions

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

Sponsors & Collaborators

  • CHA Vaccine Institute Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Kyu-Sung Rim, M.D., Ph.D. · Bundang CHA General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-28
Primary Completion
2017-08-22
Completion
2017-08-22

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02693652 on ClinicalTrials.gov