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

CHA Vaccine Institute Co., Ltd.1 site in 1 country53 target enrollmentOctober 28, 2014

ConditionsHepatitis B, Chronic

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hepatitis B, Chronic
Sponsor: CHA Vaccine Institute Co., Ltd.
Enrollment: 53
Locations: 1
Primary Endpoint: Safety and tolerability (including incidence of adverse events or expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

October 28, 2014

End Date

August 22, 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CHA Vaccine Institute Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult between 19 to 60 years of age
•Chronic hepatitis B carriers (HBsAg positive over 6 months)
•HBeAg positive patient, or patient who had lost HBeAg during Antiviral drug treatment
•Antiviral drug treated patient reducing the HBV DNA level below 2000 IU/mL measured by COBAS TaqManM HBV Test (Duration of drug administration should be over 6 months and no limitation on the type of antiviral drug)
•Patient has low ALT than 1.1 fold of upper limit of normal ALT level at screening
•Patient is able to provide written informed consent by oneself or legal representative

Exclusion Criteria

•Patient has liver diseases except chronic hepatitis B (i.e. hematochromatosis, alcoholic liver disease, nonalcoholic fatty liver disease, alpha-1 antitrypsin deficiency etc.)
•Patient has one or more test results and symptoms at the screening
•ALT \> upper limit of normal level X 1.1
•Total bilirubin \> upper limit of normal
•Prothrombin time \> Over 3 second than normal
•Serum Albumin \< 30 g/L (3 g/dL)
•Patient has history of ascites, yellow jaundice, variceal hemorrhage, hepatic encephalopathy, or liver failure
•Liver FibroScan \> F3 (F0: no fibrosis, F1: portal fibrosis, F2: periportal fibrosis, F3: septal fibrosis, F4: cirrhosis)
•Patient has one or more test results at the screening
•Hemoglobin \< 9.0 g/dL

Outcomes

Primary Outcomes

Safety and tolerability (including incidence of adverse events or expected adverse reactions for vaccine treatment) measured for 7 days after each vaccination

Time Frame: 7 days after each vaccination

Occurrence of severe local and/or systemic tolerability signs and symptoms measured for 7 days after each vaccination

Secondary Outcomes

HBeAg loss(at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group))
HBe seroconversion rate(at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group))
HBsAg loss(at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group))
HBsAg seroconversion rate(at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group))
HBV DNA level(at the 3rd and 5th month (for 3 shot group) or 6th and 8th month (for 6 shot group))
HBV specific T cell immunity(at the 3rd month (for 3 shot group) or 6th month (for 6 shot group))