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A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)

Primary Purpose

Hepatitis B Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V232 Modified Process Hepatitis B Vaccine: Lot A
V232 Modified Process Hepatitis B Vaccine: Lot B
V232 Modified Process Hepatitis B Vaccine: Lot C
V232 Current Process Hepatitis B Vaccine
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B Infection

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • In general good health
  • Female participants have a negative pregnancy test just prior to vaccination on Day 1

Exclusion Criteria:

  • History of Hepatitis B Infection or vaccination
  • Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., aluminum, yeast)
  • Administration of hepatitis B immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on Day 1
  • Receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on Day 1
  • Participation on prior study using an investigational drug or vaccine in prior 3 months
  • Known or suspected impairment of immunologic function or recent use of immunomodulatory medications, excluding topical or inhaled steroids
  • Pregnant or nursing women or women planning to become pregnant within the study period

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    V232 Modified Process Hepatitis B Vaccine: Lot A

    V232 Modified Process Hepatitis B Vaccine: Lot B

    V232 Modified Process Hepatitis B Vaccine: Lot C

    V232 Current Process Hepatitis B Vaccine

    Arm Description

    Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.

    Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.

    Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.

    Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.

    Outcomes

    Primary Outcome Measures

    Number of Participants with Seroprotection to Hepatitis B Surface Antigen
    Geometric Mean Titers to Hepatitis B Surface Antigen

    Secondary Outcome Measures

    Percentage of Participants with an Adverse Experience
    Percentage of Participants with an Injection-site Adverse Experience
    Percentage of Participants with a Systemic Adverse Experience
    Percentage of Participants with Fever (>=37.8°C, 100.0°F)

    Full Information

    First Posted
    June 20, 2007
    Last Updated
    March 15, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00489099
    Brief Title
    A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)
    Official Title
    A Study in Healthy Young Adults To Assess the Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured by a Process Upgrade
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2005 (undefined)
    Primary Completion Date
    May 2006 (Actual)
    Study Completion Date
    May 2006 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A study to evaluate the safety, tolerability, and immunogenicity of a recombinant hepatitis B vaccine manufactured using an upgrade to the production process. The primary hypotheses tested at 1 month after the third dose of vaccine are the following: 1) the 3 lots of the process upgrade vaccine induce similar seroprotection rates to hepatitis B surface antigen (HBsAg), 2) the combined lots of the process upgrade vaccine induce adequate seroprotection to HBsAg, and 3) the process upgrade vaccine will induce geometric mean antibody titers to HBsAg that are non-inferior or superior to those induced by the current process vaccine.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    V232 Modified Process Hepatitis B Vaccine: Lot A
    Arm Type
    Experimental
    Arm Description
    Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot A administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
    Arm Title
    V232 Modified Process Hepatitis B Vaccine: Lot B
    Arm Type
    Experimental
    Arm Description
    Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot B administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
    Arm Title
    V232 Modified Process Hepatitis B Vaccine: Lot C
    Arm Type
    Experimental
    Arm Description
    Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) modified process Lot C administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
    Arm Title
    V232 Current Process Hepatitis B Vaccine
    Arm Type
    Active Comparator
    Arm Description
    Recombivax HB™ (Hepatitis B Vaccine [Recombinant]) current process administered as a 1 mL intramuscular injection on Day 1, Month 1, and Month 6.
    Intervention Type
    Biological
    Intervention Name(s)
    V232 Modified Process Hepatitis B Vaccine: Lot A
    Intervention Type
    Biological
    Intervention Name(s)
    V232 Modified Process Hepatitis B Vaccine: Lot B
    Intervention Type
    Biological
    Intervention Name(s)
    V232 Modified Process Hepatitis B Vaccine: Lot C
    Intervention Type
    Biological
    Intervention Name(s)
    V232 Current Process Hepatitis B Vaccine
    Primary Outcome Measure Information:
    Title
    Number of Participants with Seroprotection to Hepatitis B Surface Antigen
    Time Frame
    1 month after the third vaccination (Month 7)
    Title
    Geometric Mean Titers to Hepatitis B Surface Antigen
    Time Frame
    1 month after the third vaccination (Month 7)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants with an Adverse Experience
    Time Frame
    Up to 15 days after any vaccination
    Title
    Percentage of Participants with an Injection-site Adverse Experience
    Time Frame
    Up to 15 days after any vaccination
    Title
    Percentage of Participants with a Systemic Adverse Experience
    Time Frame
    Up to 15 days after any vaccination
    Title
    Percentage of Participants with Fever (>=37.8°C, 100.0°F)
    Time Frame
    Up to 5 days after any vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: In general good health Female participants have a negative pregnancy test just prior to vaccination on Day 1 Exclusion Criteria: History of Hepatitis B Infection or vaccination Known or suspected hypersensitivity to any component of Recombivax HB™ vaccine (e.g., aluminum, yeast) Administration of hepatitis B immune globulin, serum immune globulin, or any other blood-derived product within 3 months prior to vaccination on Day 1 Receipt of an inactivated virus vaccine within 14 days or a live virus vaccine within 30 days prior to vaccination on Day 1 Participation on prior study using an investigational drug or vaccine in prior 3 months Known or suspected impairment of immunologic function or recent use of immunomodulatory medications, excluding topical or inhaled steroids Pregnant or nursing women or women planning to become pregnant within the study period
    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

    Citations:
    PubMed Identifier
    18690015
    Citation
    Van Damme P, Minervini G, Liss CL, McCarson B, Vesikari T, Boslego JW, Bhuyan PK. Safety, tolerability and immunogenicity of a recombinant hepatitis B vaccine manufactured by a modified process in healthy young adults. Hum Vaccin. 2009 Feb;5(2):92-7. doi: 10.4161/hv.5.2.6587. Epub 2009 Feb 14. Erratum In: Hum Vaccin Immunother. 2017 Apr 3;13(4):965.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    A Research Study to Test Safety, Tolerability, and Immunogenicity of a Recombinant Hepatitis B Vaccine Manufactured With an Upgrade to the Production Process (V232-054)

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