Overview

This trial is active, not recruiting.

Condition chronic hepatitis b
Treatment hbv vaccine (engerix b)
Phase phase 1
Sponsor Chang Gung Memorial Hospital
Start date March 2013
End date March 2015
Trial size 20 participants
Trial identifier NCT01817725, ChangGungMH 101-3594A3

Summary

Background:

The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance. There is a good chance to further increase the cure rate if the investigators can enhance the HBV-specific immune response when the HBsAg level already comes to a low level.

Hypothesis: HBsAg-based vaccine can enhance HBsAg clearance in chronic hepatitis B patients whose HBsAg already <=2000 IU/ml.

Patients and methods:

This pilot study will enroll 20 chronic hepatitis B patients with HBsAg ≦2000 IU/ml, no hepatic decompensation, no HIV coinfection, nor clinical immunodeficiency. Engerix-B vaccine (20μg for <20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one year. HBsAg quantification, anti-HBs, and HBV DNA will be surveyed regularly before each dose during the treatment period and every 3 months for another year following the last dose. Viral and cellular factors will be studied to discover determinants affecting HBsAg clearance.

Aims

1. To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate chronic HBV infection in patients with low titer HBsAg.

2. To delineate the doses to response (HBsAg clearance or decline rate) correlation so as to design a feasible schedule for future clinical trials in a larger group of patients.

3. To discover viral and host factors which can be used as biomarkers for personalized vaccine therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
hbv vaccine (engerix b)
Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) will be administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months or until HBsAg clearance. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old.

Primary Outcomes

Measure
HBsAg clearance
time frame: 2 years

Secondary Outcomes

Measure
Anti-HBs seropositivity
time frame: 2 years

Eligibility Criteria

Male or female participants from 3 years up to 80 years old.

Inclusion Criteria: 1. Naïve or treated chronic hepatitis B patients with positive HBsAg and negative HBeAg; 2. Quantitative serum HBsAg (qHBsAg) <2000 IU/ml; 3. No HIV co-infection; 4. No obvious immunodeficiency (such as renal failure, chemotherapy, radiotherapy, immunosuppressant); 5. Aged 3 to 80 years; Exclusion Criteria: 1. Pregnancy 2. Allergic to HBV vaccine or yeast. 3. Hepatic decompensation

Additional Information

Principal investigator Ming-Wei Lai
Description Vaccination schedule: Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) will be administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months or until HBsAg clearance. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old. HBsAg and anti-HBs: qHBsAg will be checked by commercial kits (Elecsys, Roche Diagnostics, Indianapolis, IN) at baseline, right before every dose, and every 3 months following the last dose for one year. ALT, AST, Alpha-fetoprotein, bilirubin and anti-HBs will be checked simultaneously.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Chang Gung Memorial Hospital.