Trial record 108 of 445 for:    hepatitis b | Open Studies

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

This study is not yet open for participant recruitment.
Verified March 2013 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Ming-Wei Lai, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01817725
First received: March 21, 2013
Last updated: March 22, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention Phase
Chronic Hepatitis B
Biological: HBV vaccine (Engerix B)
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • HBsAg clearance [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Anti-HBs seropositivity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   3 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01817725

Contacts
Contact: Ming-Wei Lai, M.D., Ph.D. 886-3-3281200 ext 8969 a22141@adm.cgmh.org.tw

Locations
Taiwan
Chang Gung Memorial Hospital Not yet recruiting
Taoyuan Xian, Taiwan, 33305
Contact: Ming-Wei Lai    886-3-3281200 ext 8969      
Principal Investigator: Ming-Wei Lai, M.D., Ph. D.         
Sub-Investigator: Chao-Wei Hsu, M.D.         
Sub-Investigator: Chau-Ting Yeh, M.D. Ph.D.         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Ming-Wei Lai Chang Gung Memorial Hospital
Principal Investigator: Chao-Wei Hsu Chang Gung Memorial Hospital
Principal Investigator: Chau-Ting Yeh Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Ming-Wei Lai, M.D., Ph.D., Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01817725     History of Changes
Other Study ID Numbers: ChangGungMH 101-3594A3
Study First Received: March 21, 2013
Last Updated: March 22, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Therapeutic vaccine
HBsAg clearance
Immune clearance
HBsAg clearance induced by vaccination
s seroconversion in carriers after vaccination

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on April 15, 2014