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Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)
Comparator: Modified Process Hepatitis B Vaccine (Experimental)
Comparator: ENGERIX-B™ (currently licensed product)
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

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy male and female older adults greater than or equal to 50 years of age

Exclusion Criteria:

  • Any adult with a history of previous hepatitis B infection
  • A history of vaccination with any hepatitis B vaccine
  • Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF)
  • Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast)
  • Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product
  • Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine
  • Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine
  • Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine
  • Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids
  • Pregnant women, nursing mothers, and women planning to become pregnant within the study period
  • Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    RECOMBIVAX HB™

    Modified Process Hepatitis B Vaccine

    ENGERIX-B™

    Outcomes

    Primary Outcome Measures

    The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)
    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 vaccination) and at Month 7 (1 month after the third vaccination).

    Secondary Outcome Measures

    The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)
    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 vaccination) and at Month 7 (1 month after the third vaccination).
    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

    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
    NCT00440531
    Brief Title
    Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)
    Official Title
    A Study in Healthy Adults 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
    November 2006 (undefined)
    Primary Completion Date
    November 2007 (Actual)
    Study Completion Date
    November 2007 (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
    The purpose of this trial is to determine if there is an improvement in the immune response of older adults over 50 years of age using a modified process hepatitis B vaccine and a currently licensed hepatitis B vaccine (RECOMBIVAX HB™).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    540 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    RECOMBIVAX HB™
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Modified Process Hepatitis B Vaccine
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    ENGERIX-B™
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant)
    Intervention Description
    RECOMBIVAX HB™ (currently licensed product) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Modified Process Hepatitis B Vaccine (Experimental)
    Intervention Description
    Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 doses of 10 mcg (micrograms)/1.0 mL each over 6 months.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: ENGERIX-B™ (currently licensed product)
    Intervention Description
    ENGERIX-B™ given IM (Intramuscular) in 3 doses of 20 mcg (micrograms)/1.0 mL each over 6 months.
    Primary Outcome Measure Information:
    Title
    The Number of Seroresponders to the Modified Process Hepatitis B Vaccine and RECOMBIVAX HB™ (Currently Licensed Vaccine)
    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 vaccination) and at Month 7 (1 month after the third vaccination).
    Time Frame
    7 months (1 month after third vaccination)
    Secondary Outcome Measure Information:
    Title
    The Number of Seroresponders to ENGERIX-B™ (Currently Licensed Vaccine)
    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 vaccination) and at Month 7 (1 month after the third vaccination).
    Time Frame
    7 months (1 month after third vaccination)
    Title
    The Total Number of Participants With One or More Injection-site Adverse Experiences
    Time Frame
    Days 1-5 After Any Vaccination
    Title
    The Total Number of Participants With a Maximum Temperature >=100.0F/37.8C
    Time Frame
    Day 1-5 After Vaccination
    Title
    The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
    Time Frame
    During Entire Study Period (from first vaccination until the participant completes or discontinues: up to 7 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy male and female older adults greater than or equal to 50 years of age Exclusion Criteria: Any adult with a history of previous hepatitis B infection A history of vaccination with any hepatitis B vaccine Recent (<72 hours) history of febrile illness (oral temperature =37.8ºC/=100.0ºF) Known or suspected hypersensitivity to any component of RECOMBIVAX HB™ or ENGERIX-B™ (e.g., aluminum, yeast) Recent administration (within 3 months prior to first injection with the study vaccine) of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product Receipt of licensed inactivated vaccines within 14 days prior to first injection with the study vaccine Receipt of licensed live virus vaccines within the 30 days prior to injection with the study vaccine Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids Pregnant women, nursing mothers, and women planning to become pregnant within the study period Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives
    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
    22185811
    Citation
    Gilbert CL, Klopfer SO, Martin JC, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy adults >/=50 years. Hum Vaccin. 2011 Dec;7(12):1336-42. doi: 10.4161/hv.7.12.18333. Epub 2011 Dec 1.
    Results Reference
    derived

    Learn more about this trial

    Study of Recombinant Modified Process Hepatitis B Vaccine in Older Adults (V232-059)(COMPLETED)

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