Effect of Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg—a Pilot Study

Chronic Hepatitis B Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01817725
• Other study ID #: ChangGungMH 101-3594A3
• Status: Active, not recruiting
• Phase: Phase 1
• First received: March 21, 2013
• Last updated: February 3, 2015
• Start date: March 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2015
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan Xian

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBsAg clearance		2 years	Yes
Secondary	Anti-HBs seropositivity		2 years	Yes