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Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients

Primary Purpose

Renal Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
four doses of Euvax B vaccine
20 μg (1 ml) three doses of Euvax B vaccine
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Failure focused on measuring predialysed, chronic, renal failure patients

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • predialysis patients,
  • > 18 years with mild and moderate chronic renal failure,
  • serum creatinine between 1.5-6 mg/dl

Exclusion Criteria:

  • patients with severe renal failure,
  • serum creatinine > 6 mg/dl,
  • requiring dialysis or expected to require dialysis within 1 year,
  • receiving immunosuppressive treatment,
  • known lymphoproliferative disorder.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    40 μg (2 ml) four doses of Euvax B vaccine

    20 μg (1 ml) three doses of Euvax B vaccine

    Arm Description

    40 μg (2 ml) four doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)

    20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)

    Outcomes

    Primary Outcome Measures

    Hepatitis B surface antibody mIU/ml
    Anti-HBs titres less than 10 mIU/ml were defined as non-seroconversion or non-responder. Anti-HBs titres greater than or equal to 10 mIU/ml but less than 100 mIU/ml were defined as seroconversion with low level antibody. Anti- HBs titres greater than or equal to100 mIU/ml were defined as seroconversion with protective levels of hepatitis B antibody.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 2011
    Last Updated
    November 8, 2011
    Sponsor
    Tehran University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01468051
    Brief Title
    Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients
    Official Title
    A Randomized Controlled Trial of Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    October 2008 (Actual)
    Study Completion Date
    October 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tehran University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Patients with chronic renal disease have to be vaccinated as soon as dialysis is forestalled and this could improve seroconversion rate of hepatitis B vaccination. In this study, the investigators aimed to compare seroconversion rates and immune response rates using four doses of 40 μg and three doses of 20 μg of Euvax B recombinant hepatitis B surface antigen (HBsAg) vaccine given to predialysis CKD patients.
    Detailed Description
    In an open, randomized clinical trial, the investigators compared seroconversion rates in 51 predialysis patients with mild and moderate chronic renal failure using either 40 μg 4 doses or 20 μg 3 doses of Euvax B recombinant hepatitis B vaccine administered at 0, 1, 2, 6 and 0, 1, 6 months respectively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Failure
    Keywords
    predialysed, chronic, renal failure patients

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    40 μg (2 ml) four doses of Euvax B vaccine
    Arm Type
    Experimental
    Arm Description
    40 μg (2 ml) four doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
    Arm Title
    20 μg (1 ml) three doses of Euvax B vaccine
    Arm Type
    Experimental
    Arm Description
    20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
    Intervention Type
    Biological
    Intervention Name(s)
    four doses of Euvax B vaccine
    Other Intervention Name(s)
    Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
    Intervention Description
    40 μg (2 ml) four doses of Euvax B vaccine
    Intervention Type
    Biological
    Intervention Name(s)
    20 μg (1 ml) three doses of Euvax B vaccine
    Intervention Description
    20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
    Primary Outcome Measure Information:
    Title
    Hepatitis B surface antibody mIU/ml
    Description
    Anti-HBs titres less than 10 mIU/ml were defined as non-seroconversion or non-responder. Anti-HBs titres greater than or equal to 10 mIU/ml but less than 100 mIU/ml were defined as seroconversion with low level antibody. Anti- HBs titres greater than or equal to100 mIU/ml were defined as seroconversion with protective levels of hepatitis B antibody.
    Time Frame
    8-10 weeks after the 6-month dose of vaccine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: predialysis patients, > 18 years with mild and moderate chronic renal failure, serum creatinine between 1.5-6 mg/dl Exclusion Criteria: patients with severe renal failure, serum creatinine > 6 mg/dl, requiring dialysis or expected to require dialysis within 1 year, receiving immunosuppressive treatment, known lymphoproliferative disorder.

    12. IPD Sharing Statement

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    Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients

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