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Trial record 2 of 2 for:    engerix-b gsk | Hepatitis B | Phase 1

Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01817725
Recruitment Status : Completed
First Posted : March 25, 2013
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Ming-Wei Lai, Chang Gung Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Biological: HBV vaccine (Engerix B) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg-a Pilot Study
Study Start Date : March 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Engerix-B
Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old
Biological: HBV vaccine (Engerix B)
Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old.




Primary Outcome Measures :
  1. Change in HBsAg Levels From Baseline to 2 Years [ Time Frame: 2 years ]
    The difference of HBsAg levels at the end of follow up (2 years) and baseline


Secondary Outcome Measures :
  1. Anti-HBs Seropositivity [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817725


Locations
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Taiwan
Chang Gung Memorial Hospital
Taoyuan Xian, Taiwan, 33305
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ming-Wei Lai, M.D., Ph.D., Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01817725    
Other Study ID Numbers: ChangGungMH 101-3594A3
First Posted: March 25, 2013    Key Record Dates
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ming-Wei Lai, 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:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections