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Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients

Primary Purpose

Hepatitis B, Hemodialysis Complication

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hepatitis B recombinant DNA vaccine
Combined hepatitis A and B vaccine
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age was above 18 years
  • Hemodialysis patient
  • All patients had undetectable hepatitis B virus surface antigen and antibody

Exclusion Criteria:

  • A positive serum hepatitis B virus surface antigen and antibody
  • patient received a previous course of hepatitis B virus vaccine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Hepatitis B recombinant DNA vaccine

    Combined hepatitis A and B vaccine

    Arm Description

    Each Hepatitis B recombinant DNA vaccine vial contained 20 microgram of vaccine dose. Two vials will be intramuscularly injected one vial in each deltoid muscle on months zero, one, two and six.

    Each one-milliliter dose of vaccine contains 720 ELISA units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum. Two vials will be intramuscularly injected one vial in each deltoid muscle on on days zero, seven, and 21.

    Outcomes

    Primary Outcome Measures

    Hepatitis B virus Seroprotection after one month
    Hepatitis B virus surface antibodies titer after one month
    Hepatitis B virus Seroprotection after three months
    Hepatitis B virus surface antibodies titer after three month

    Secondary Outcome Measures

    Fever
    The proportion of fever among patients in both arms
    Pain scale
    Visual pain scale for pain from injection

    Full Information

    First Posted
    May 8, 2017
    Last Updated
    February 6, 2023
    Sponsor
    Benha University
    Collaborators
    New Jeddah Clinic Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03149874
    Brief Title
    Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients
    Official Title
    Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients, Does it Works?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1, 2014 (Actual)
    Primary Completion Date
    April 30, 2017 (Actual)
    Study Completion Date
    May 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Benha University
    Collaborators
    New Jeddah Clinic Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to examine the result of seroprotection using the accelerated vaccination schedule in vaccination of hemodialysis patient through using combined hepatitis A and B vaccine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B, Hemodialysis Complication

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    Patient seuentially randomized to either vaccine
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    114 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hepatitis B recombinant DNA vaccine
    Arm Type
    Active Comparator
    Arm Description
    Each Hepatitis B recombinant DNA vaccine vial contained 20 microgram of vaccine dose. Two vials will be intramuscularly injected one vial in each deltoid muscle on months zero, one, two and six.
    Arm Title
    Combined hepatitis A and B vaccine
    Arm Type
    Active Comparator
    Arm Description
    Each one-milliliter dose of vaccine contains 720 ELISA units of inactivated hepatitis A virus and 20 mcg of recombinant HBsAg protein. One dose of vaccine also contains 0.45 mg of aluminum. Two vials will be intramuscularly injected one vial in each deltoid muscle on on days zero, seven, and 21.
    Intervention Type
    Drug
    Intervention Name(s)
    Hepatitis B recombinant DNA vaccine
    Intervention Description
    Hepatitis B recombinant DNA vaccine
    Intervention Type
    Drug
    Intervention Name(s)
    Combined hepatitis A and B vaccine
    Intervention Description
    Combined hepatitis A and B vaccine given to the patients
    Primary Outcome Measure Information:
    Title
    Hepatitis B virus Seroprotection after one month
    Description
    Hepatitis B virus surface antibodies titer after one month
    Time Frame
    one month after third dose of the vaccine
    Title
    Hepatitis B virus Seroprotection after three months
    Description
    Hepatitis B virus surface antibodies titer after three month
    Time Frame
    three months after third dose of the vaccine
    Secondary Outcome Measure Information:
    Title
    Fever
    Description
    The proportion of fever among patients in both arms
    Time Frame
    4 Days after each vaccination dose
    Title
    Pain scale
    Description
    Visual pain scale for pain from injection
    Time Frame
    1 Hour after each vaccination dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age was above 18 years Hemodialysis patient All patients had undetectable hepatitis B virus surface antigen and antibody Exclusion Criteria: A positive serum hepatitis B virus surface antigen and antibody patient received a previous course of hepatitis B virus vaccine

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients

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