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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT01251276
Collaborator
(none)
204
2
4.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Modified Process Hepatitis B Vaccine
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
204 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Nov 30, 2010
Actual Primary Completion Date :
Apr 12, 2011
Actual Study Completion Date :
Apr 12, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Modified Process Hepatitis B Vaccine in Base Study

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

Biological: Modified Process Hepatitis B Vaccine
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
Other Names:
  • HBVaxPro
  • Experimental: ENGERIX-B™ Vaccine in Base 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

    Biological: Modified Process Hepatitis B Vaccine
    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
    Other Names:
  • HBVaxPro
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Seroresponders Before and After the Challenge Vaccination [Predose (Day 1) and 1 month after challenge dose (Month 1)]

      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

    1. Percentage of Participants With One or More Adverse Experiences [Up to Day 15 after challenge dose]

      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.

    2. Percentage of Participants Who Discontinued the Study Due to an Adverse Experience [Up to Month 7]

      The percentage of participants who discontinued the study due to an adverse experience was assessed.

    3. Percentage of Participants With One or More Injection-site Adverse Experiences [Up to Day 15 after challenge dose]

      The percentage of participants with one or more injection-site adverse experiences was assessed.

    4. Percentage of Participants With One or More Systemic Adverse Experiences [Up to Day 15 after challenge dose]

      The percentage of participants with one or more systemic adverse experiences was assessed.

    5. Percentage of Participants With One or More Serious Adverse Experiences [Up to Month 1 after challenge dose]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    • Study Director: Medical Director, Merck Sharp & Dohme LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT01251276
    Other Study ID Numbers:
    • V232-059-10
    • rHB01C
    • 2006-003649-18
    First Posted:
    Dec 1, 2010
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details A total of 296 participants were eligible for the challenge-dose study and 204 were enrolled
    Pre-assignment Detail Study participants received 3 doses of Modified Process Hepatitis B Vaccine or ENGERIX-B™ vaccine in the Base Study (V232-059, NCT00440531). Two years after completion of the Base Study vaccinations, participants were eligible to receive one challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study.
    Arm/Group Title Modified Process Hepatitis B Vaccine in Base Study ENGERIX-B™ Vaccine in Base Study
    Arm/Group Description Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received 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 received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
    Period Title: Overall Study
    STARTED 96 108
    Vaccinated 96 108
    COMPLETED 95 107
    NOT COMPLETED 1 1

    Baseline Characteristics

    Arm/Group Title Modified Process Hepatitis B Vaccine in Base Study ENGERIX-B™ Vaccine in Base Study Total
    Arm/Group Description Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received 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 received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study Total of all reporting groups
    Overall Participants 96 108 204
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    63.8
    (7.3)
    63.6
    (6.7)
    63.7
    (7.0)
    Sex: Female, Male (Count of Participants)
    Female
    48
    50%
    63
    58.3%
    111
    54.4%
    Male
    48
    50%
    45
    41.7%
    93
    45.6%

    Outcome Measures

    1. Primary Outcome
    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)

    Outcome Measure Data

    Analysis Population Description
    Vaccinated participants with immunogenicity results, excluding those with protocol violations that might interfere with the immunogenicity evaluation
    Arm/Group Title Modified Process Hepatitis B Vaccine in Base Study ENGERIX-B™ Vaccine in Base Study
    Arm/Group Description Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received 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 received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
    Measure Participants 88 103
    Predose (Day 1); n=88, 102
    45.5
    47.4%
    58.8
    54.4%
    Postdose (Month 1); n=88, 103
    85.2
    88.8%
    88.3
    81.8%
    2. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants who received a challenge dose and had safety follow-up
    Arm/Group Title Modified Process Hepatitis B Vaccine in Base Study ENGERIX-B™ Vaccine in Base Study
    Arm/Group Description Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received 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 received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
    Measure Participants 96 107
    Number [Percentage of participants]
    39.6
    41.3%
    45.8
    42.4%
    3. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants who received a challenge dose and had safety follow-up
    Arm/Group Title Modified Process Hepatitis B Vaccine in Base Study ENGERIX-B™ Vaccine in Base Study
    Arm/Group Description Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received 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 received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
    Measure Participants 96 107
    Number [Percentage of participants]
    0
    0%
    0
    0%
    4. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants who received a challenge dose and had safety follow-up
    Arm/Group Title Modified Process Hepatitis B Vaccine in Base Study ENGERIX-B™ Vaccine in Base Study
    Arm/Group Description Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received 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 received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
    Measure Participants 96 107
    Number [Percentage of participants]
    35.4
    36.9%
    29.9
    27.7%
    5. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants who received a challenge dose and had safety follow-up
    Arm/Group Title Modified Process Hepatitis B Vaccine in Base Study ENGERIX-B™ Vaccine in Base Study
    Arm/Group Description Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received 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 received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
    Measure Participants 96 107
    Number [Percentage of participants]
    16.7
    17.4%
    28.0
    25.9%
    6. Secondary Outcome
    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

    Outcome Measure Data

    Analysis Population Description
    Participants who received a challenge dose and had safety follow-up
    Arm/Group Title Modified Process Hepatitis B Vaccine in Base Study ENGERIX-B™ Vaccine in Base Study
    Arm/Group Description Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received 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 received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
    Measure Participants 96 107
    Number [Percentage of participants]
    0
    0%
    0.9
    0.8%

    Adverse Events

    Time Frame All adverse events: up to Day 15 after the challenge dose; serious adverse events: up to 1 month after the challenge dose
    Adverse Event Reporting Description The Safety Analysis Set included participants who received the challenge dose vaccination and had safety follow-up
    Arm/Group Title Modified Process Hepatitis B Vaccine in Base Study ENGERIX-B™ Vaccine in Base Study
    Arm/Group Description Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study received 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 received a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study
    All Cause Mortality
    Modified Process Hepatitis B Vaccine in Base Study ENGERIX-B™ Vaccine in Base Study
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Modified Process Hepatitis B Vaccine in Base Study ENGERIX-B™ Vaccine in Base Study
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/96 (0%) 1/107 (0.9%)
    Psychiatric disorders
    Bipolar disorder 0/96 (0%) 0 1/107 (0.9%) 1
    Other (Not Including Serious) Adverse Events
    Modified Process Hepatitis B Vaccine in Base Study ENGERIX-B™ Vaccine in Base Study
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 34/96 (35.4%) 30/107 (28%)
    General disorders
    Injection-site erythema 7/96 (7.3%) 7 5/107 (4.7%) 5
    Injection-site pain 31/96 (32.3%) 31 27/107 (25.2%) 27
    Injection-site swelling 7/96 (7.3%) 7 4/107 (3.7%) 4

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study sixty (60) days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.

    Results Point of Contact

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck Sharp & Dohme Corp.
    Phone 1-800-672-6372
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT01251276
    Other Study ID Numbers:
    • V232-059-10
    • rHB01C
    • 2006-003649-18
    First Posted:
    Dec 1, 2010
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022