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Hepatitis B Challenge Dose in Adults (V232-059-10)

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Modified Process Hepatitis B Vaccine
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:

  • In general good health based on a medical history.
  • Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study.

Exclusion Criteria:

  • Known history of previous Hepatitis B infection.
  • History of vaccination with any Hepatitis B vaccine within the last 2 years.
  • History of febrile illness.
  • Known or suspected hypersensitivity to any component of HBVaxPro.
  • Receipt of medication / vaccine that may interfere with study assessments.
  • Known or suspected immune impairment.
  • Pregnant women and nursing mothers.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Modified Process Hepatitis B Vaccine in Base Study

    ENGERIX-B™ Vaccine in Base Study

    Arm Description

    Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study

    Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study

    Outcomes

    Primary Outcome Measures

    Percentage of Seroresponders Before and After the Challenge Vaccination
    A seroresponder was a participant with an anti-hepatitis B surface antibody titer >=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.

    Secondary Outcome Measures

    Percentage of Participants With One or More Adverse Experiences
    An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse experience. The percentage of participants with one or more adverse experiences was assessed.
    Percentage of Participants Who Discontinued the Study Due to an Adverse Experience
    The percentage of participants who discontinued the study due to an adverse experience was assessed.
    Percentage of Participants With One or More Injection-site Adverse Experiences
    The percentage of participants with one or more injection-site adverse experiences was assessed.
    Percentage of Participants With One or More Systemic Adverse Experiences
    The percentage of participants with one or more systemic adverse experiences was assessed.
    Percentage of Participants With One or More Serious Adverse Experiences
    A serious adverse experience is an adverse experience that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse experiences was assessed.

    Full Information

    First Posted
    November 23, 2010
    Last Updated
    August 24, 2022
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01251276
    Brief Title
    Hepatitis B Challenge Dose in Adults (V232-059-10)
    Official Title
    A Study to Estimate the Immune Response Following a Challenge Dose in Adults (≥50 Years Old) Vaccinated With a Primary Series of an Hepatitis B Vaccine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 30, 2010 (Actual)
    Primary Completion Date
    April 12, 2011 (Actual)
    Study Completion Date
    April 12, 2011 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this trial is to describe the Seroprotection Rate (SPR) at least 2 years following completion of a primary series with a hepatitis B vaccine (Base Study V232-059, NCT00440531) and 1 month following a challenge dose with a Modified Process Hepatitis B vaccine.

    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
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    204 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Modified Process Hepatitis B Vaccine in Base Study
    Arm Type
    Experimental
    Arm Description
    Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
    Arm Title
    ENGERIX-B™ Vaccine in Base Study
    Arm Type
    Experimental
    Arm Description
    Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
    Intervention Type
    Biological
    Intervention Name(s)
    Modified Process Hepatitis B Vaccine
    Other Intervention Name(s)
    HBVaxPro
    Intervention Description
    Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study
    Primary Outcome Measure Information:
    Title
    Percentage of Seroresponders Before and After the Challenge Vaccination
    Description
    A seroresponder was a participant with an anti-hepatitis B surface antibody titer >=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.
    Time Frame
    Predose (Day 1) and 1 month after challenge dose (Month 1)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With One or More Adverse Experiences
    Description
    An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor's product, is also an adverse experience. The percentage of participants with one or more adverse experiences was assessed.
    Time Frame
    Up to Day 15 after challenge dose
    Title
    Percentage of Participants Who Discontinued the Study Due to an Adverse Experience
    Description
    The percentage of participants who discontinued the study due to an adverse experience was assessed.
    Time Frame
    Up to Month 7
    Title
    Percentage of Participants With One or More Injection-site Adverse Experiences
    Description
    The percentage of participants with one or more injection-site adverse experiences was assessed.
    Time Frame
    Up to Day 15 after challenge dose
    Title
    Percentage of Participants With One or More Systemic Adverse Experiences
    Description
    The percentage of participants with one or more systemic adverse experiences was assessed.
    Time Frame
    Up to Day 15 after challenge dose
    Title
    Percentage of Participants With One or More Serious Adverse Experiences
    Description
    A serious adverse experience is an adverse experience that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or may jeopardize the participant and may require medical or surgical intervention. The percentage of participants with one or more serious adverse experiences was assessed.
    Time Frame
    Up to Month 1 after challenge dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: In general good health based on a medical history. Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study. Exclusion Criteria: Known history of previous Hepatitis B infection. History of vaccination with any Hepatitis B vaccine within the last 2 years. History of febrile illness. Known or suspected hypersensitivity to any component of HBVaxPro. Receipt of medication / vaccine that may interfere with study assessments. Known or suspected immune impairment. Pregnant women and nursing mothers.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    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://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    25996838
    Citation
    Sharma R, Ahlm C, Ostergaard L, Dowell A, Tran C, Thomas S, Eymin C. Persistence of immunity in healthy adults aged >/= 50 years primed with a hepatitis B vaccine 3 years previously. Hum Vaccin Immunother. 2015;11(7):1709-16. doi: 10.1080/21645515.2015.1019187.
    Results Reference
    result

    Learn more about this trial

    Hepatitis B Challenge Dose in Adults (V232-059-10)

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