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Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)

Primary Purpose

Hepatitis B Virus Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: modified process hepatitis B vaccine
Comparator: ENGERIX-B™
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B Virus Infection focused on measuring hepatitis B virus

Eligibility Criteria

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

Inclusion Criteria:

  • Male and female subjects at least 18 years of age
  • Laboratory confirmed negative serology result to HbsAg (hepatitis b virus), anti-HBs (antibody to hepatitis B surface antigen), and anti HBc (antibody to hepatitis B core antigen) within 6 weeks of the initial dose of study vaccine
  • Patient on renal dialysis or a pre-dialysis patient with a creatinine clearance of <=30 ml/min

Exclusion Criteria:

  • Previous hepatitis B infection, vaccination with any hepatitis B vaccine
  • Recent febrile illness; hypersensitivity to any component of licensed hepatitis B vaccines
  • Recent administration of immune globulin, licensed inactivated vaccine within 14 days or licensed live vaccine within 30 days prior to receipt of first study vaccine
  • Receipt of investigational drugs or investigational vaccines within 3 months prior
  • Impairment of immunologic function
  • Recent use of systemic immunomodulatory medications
  • Pregnant women, nursing mothers or women planning to become pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Modified process hepatitis B vaccine

    ENGERIX-B™2

    Arm Description

    Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.

    ENGERIX-B™ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.

    Outcomes

    Primary Outcome Measures

    The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7
    The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 7 (1 month after the third dose).
    The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9
    The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 9 (1 month after the fourth dose).
    The Total Number of Participants With One or More Injection-Site Adverse Experiences
    The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C
    The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
    Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose).

    Secondary Outcome Measures

    Full Information

    First Posted
    February 26, 2007
    Last Updated
    March 16, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00440297
    Brief Title
    Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)
    Official Title
    A Study in Renal Predialysis and Dialysis Patients of the Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    May 2008 (Actual)
    Study Completion Date
    May 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis B Virus Infection
    Keywords
    hepatitis B virus

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    277 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Modified process hepatitis B vaccine
    Arm Type
    Experimental
    Arm Description
    Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.
    Arm Title
    ENGERIX-B™2
    Arm Type
    Active Comparator
    Arm Description
    ENGERIX-B™ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: modified process hepatitis B vaccine
    Intervention Description
    Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: ENGERIX-B™
    Intervention Description
    ENGERIX-B™ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months.
    Primary Outcome Measure Information:
    Title
    The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 7
    Description
    The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 7 (1 month after the third dose).
    Time Frame
    7 months (1 month after the third dose)
    Title
    The Number of Seroprotected Participants to the Modified Process Hepatitis B Vaccine and ENGERIX-B™ (Currently Licensed Vaccine) at Month 9
    Description
    The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 9 (1 month after the fourth dose).
    Time Frame
    9 months (1 month after the fourth dose)
    Title
    The Total Number of Participants With One or More Injection-Site Adverse Experiences
    Time Frame
    Days 1-15 After Any Vaccination
    Title
    The Total Number of Participants With a Maximum Temperature >= 100.0F / 37.8C
    Time Frame
    Days 1-5 After Any Vaccination
    Title
    The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
    Description
    Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose).
    Time Frame
    0-9 months (recorded from first dose until the participant completes or discontinues the study)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and female subjects at least 18 years of age Laboratory confirmed negative serology result to HbsAg (hepatitis b virus), anti-HBs (antibody to hepatitis B surface antigen), and anti HBc (antibody to hepatitis B core antigen) within 6 weeks of the initial dose of study vaccine Patient on renal dialysis or a pre-dialysis patient with a creatinine clearance of <=30 ml/min Exclusion Criteria: Previous hepatitis B infection, vaccination with any hepatitis B vaccine Recent febrile illness; hypersensitivity to any component of licensed hepatitis B vaccines Recent administration of immune globulin, licensed inactivated vaccine within 14 days or licensed live vaccine within 30 days prior to receipt of first study vaccine Receipt of investigational drugs or investigational vaccines within 3 months prior Impairment of immunologic function Recent use of systemic immunomodulatory medications Pregnant women, nursing mothers or women planning to become pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    25252192
    Citation
    Gilbert CL, Stek JE, Villa G, Klopfer SO, Martin JC, Schodel FP, Bhuyan PK. Safety and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in renal pre-dialysis and dialysis patients. Vaccine. 2014 Nov 12;32(48):6521-6. doi: 10.1016/j.vaccine.2014.09.015. Epub 2014 Sep 22.
    Results Reference
    result

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    Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)

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