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Impact of Hepatitis B Vaccination on HBs Antigenemia

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ClinicalTrials.gov Identifier: NCT03193775
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Amr Shaaban Hanafy, Zagazig University

Brief Summary:
  • HBV is not curable with persistent HBsAg even after the disappearance of HBV DNA.
  • HBsAg > 1000 IU/ml is associated with the risk of virological recurrence and HCC.
  • There is an impaired immune response to HBsAg and HBV vaccine is an easily available, cost-effective, non-harmful method of stimulating immunity.

Condition or disease Intervention/treatment Phase
HBV Biological: HBV vaccine Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Group I: inactive carriers (n=100). Group II: CHB exposed to nucleos(t)ides (n=120) till 6 months after HBe seroconversion and HBV DNA disappearance in HBeAg positive (n=60) or DNA disappearance in HBeAg negative patients (n=60). All showed persistent HBs antigenemia.

-A control group (n=100) did not receive HBV vaccine

Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
Official Title: Impact of Hepatitis B Vaccination on HBsAg Kinetics, Interferon-inducible Protein 10 Level and Recurrence of Viremia
Actual Study Start Date : August 1, 2011
Actual Primary Completion Date : October 1, 2015
Actual Study Completion Date : October 1, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: chronic HBV with persistent HBsAg

inactive carriers (n=100). Group II: CHB exposed to nucleos(t)ides (n=120) till 6 months after HBe seroconversion and HBV DNA disappearance in HBeAg positive (n=60) or DNA disappearance in HBeAg negative patients (n=60). All showed persistent HBs antigenemia.

they were given 30 µg of HBV vaccine initiated 6 months after HBe seroconversion and disappearance of HBV DNA.

Biological: HBV vaccine
HBV vaccine which contains Purified HBsAg produced by recombinant DNA technology (Euvax-B, LG Life sciences, Korea) intramuscularly in deltoid region at three different time intervals (0, 1, 6 months).

No Intervention: control group
A control group (n=100) did not receive HBV vaccine



Primary Outcome Measures :
  1. production of protective HBsAb [ Time Frame: three months after the last dose of vaccine ]
    Current treatment by NAs may suppress HBV replication but cannot completely eradicate the virus due to the systemic immune tolerance or exhaustion. HBV vaccine may enhance the immunity against HBsAg and may be an efficient immunotherapy in chronic HBV.


Secondary Outcome Measures :
  1. impact on Insulin resistance, fibrosis regression [ Time Frame: 3 month after the last dose of vaccination ]
    study of the possibility of improving insulin resistance and degree of fibrosis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • HBV patients with persistent HBs antigenemia

Exclusion Criteria:

  • decompensated liver cirrhosis
  • hepatocellular carcinoma
  • other causes of liver disease or mixed causes (excessive alcohol consumption,
  • autoimmune liver disease
  • immunosuppressive drugs
  • infection with hepatitis C virus.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amr Shaaban Hanafy, Assistant professor, Zagazig University
ClinicalTrials.gov Identifier: NCT03193775     History of Changes
Other Study ID Numbers: 3777
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amr Shaaban Hanafy, Zagazig University:
HBV vaccine
persistent
HBsAg
IP-10

Additional relevant MeSH terms:
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Hepatitis B
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs