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Edible Hepatitis B Vaccine Therapy in Healthy Participants Who Have Undergone Previous Vaccination

Primary Purpose

Healthy, no Evidence of Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
hepatitis B antigen peptide
placebo
immunoenzyme technique
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy, no Evidence of Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All Roswell Park Cancer Institute (RPCI) staff, faculty, and students, who are in good health
  • Participants confirmation of history of primary immunization series with recombinant hepatitis B (HB) vaccine (last dose at least one year prior to screening anti-HBs level assessment)
  • Current anti-HBs levels less than or equal to 115 mIU/mL
  • Major organ functions within acceptable medical limits as determined in routine clinical laboratory screening tests
  • Expected availability for the duration of the study period
  • If female, then documentation that the subject is not pregnant by an acceptable laboratory test and that the subject is using an adequate birth control method to prevent pregnancy for at least 3 months following the last immunization in the study
  • Human immunodeficiency virus (HIV) antibody negative
  • Ability to provide written informed consent
  • Supervisor approval

Exclusion Criteria:

  • Known history of allergy or hypersensitivity to potato, potato components or potato products
  • Known history of allergy to hepatitis B vaccine in any form or to components of hepatitis B vaccine
  • Pregnancy or breast feeding
  • Current anti-HBS levels greater than 115 mIU/mL
  • Known immunodeficiency, cancer, or use of immunosuppressive medication including cancer chemotherapy and systemic steroids (excluding intermittent use of topical steroids)
  • Participation in another investigational study within 30 days of enrollment in this study
  • Known and currently active gastrointestinal disease including any of the following: peptic ulcer disease, gastroesophageal reflux, inflammatory bowel disease, diverticulitis, or pancreatitis
  • Use of prescription medication or over the counter H2 blockers or proton pump inhibitors (PPIs) for any of the above diseases regularly and within 1 month of enrollment
  • Diagnosis of insulin-dependent diabetes or multiple sclerosis
  • Significant laboratory abnormality which suggests dysfunction of hematological, renal, or hepatic systems
  • Known history of hepatitis B infection in the past
  • Temporary exclusion for mild upper respiratory illness, gastrointestinal illness, or other febrile episode that is expected and documented to resolve

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Arm I

    Arm II

    Arm III

    Arm IV

    Arm Description

    Participants consume placebo HBV-EPV on days 0, 14, 28, and 56.

    Participants consume HBV-EPV expressing HBsAg on days 0 and 28 and placebo HBV-EPV on days 14 and 56.

    Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14.

    Participants consume HBV-EPV expressing HBsAg on days 0, 14, 28, and 56.

    Outcomes

    Primary Outcome Measures

    Maximum fold increase in anti-HBsAg titer levels relative to baseline levels

    Secondary Outcome Measures

    Absolute maximum response
    Area under the curve
    Proportion of two-fold responses in anti-HBsAg titer levels

    Full Information

    First Posted
    February 8, 2011
    Last Updated
    September 30, 2022
    Sponsor
    Roswell Park Cancer Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01292421
    Brief Title
    Edible Hepatitis B Vaccine Therapy in Healthy Participants Who Have Undergone Previous Vaccination
    Official Title
    Pilot Study Testing the Immunogenic Efficacy of an Edible Vaccine for Hepatitis B in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    December 2013 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Roswell Park Cancer Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    RATIONALE: Hepatitis B antigen peptide (HBsAg) vaccine may help the body build an immune response and help prevent hepatitis B. PURPOSE: This clinical trial studies edible HBsAg vaccine therapy in healthy participants who have undergone previous vaccination.
    Detailed Description
    OBJECTIVES: I. To evaluate the safety, tolerability, and immunogenicity of orally delivered HBsAg that is formulated as an expressed protein in transgenic potato tubers (HBV-EPV) at different doses and schedules. OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM I: Participants consume placebo HBV-EPV on days 0, 14, 28, and 56. ARM II: Participants consume HBV-EPV expressing HBsAg on days 0 and 28 and placebo HBV-EPV on days 14 and 56. ARM III: Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14. ARM IV: Participants consume HBV-EPV expressing HBsAg on days 0, 14, 28, and 56. After completion of study treatment, patients are followed up at days 70, 84, 98, and 114.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy, no Evidence of Disease

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I
    Arm Type
    Placebo Comparator
    Arm Description
    Participants consume placebo HBV-EPV on days 0, 14, 28, and 56.
    Arm Title
    Arm II
    Arm Type
    Experimental
    Arm Description
    Participants consume HBV-EPV expressing HBsAg on days 0 and 28 and placebo HBV-EPV on days 14 and 56.
    Arm Title
    Arm III
    Arm Type
    Experimental
    Arm Description
    Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14.
    Arm Title
    Arm IV
    Arm Type
    Experimental
    Arm Description
    Participants consume HBV-EPV expressing HBsAg on days 0, 14, 28, and 56.
    Intervention Type
    Biological
    Intervention Name(s)
    hepatitis B antigen peptide
    Other Intervention Name(s)
    HBsAg, peptide, hepatitis B antigen
    Intervention Description
    Given PO
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Other Intervention Name(s)
    PLCB
    Intervention Description
    Given orally (PO)
    Intervention Type
    Other
    Intervention Name(s)
    immunoenzyme technique
    Other Intervention Name(s)
    immunoenzyme techniques
    Intervention Description
    Correlative studies
    Primary Outcome Measure Information:
    Title
    Maximum fold increase in anti-HBsAg titer levels relative to baseline levels
    Time Frame
    Over 70 days
    Secondary Outcome Measure Information:
    Title
    Absolute maximum response
    Time Frame
    On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
    Title
    Area under the curve
    Time Frame
    On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114
    Title
    Proportion of two-fold responses in anti-HBsAg titer levels
    Time Frame
    On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All Roswell Park Cancer Institute (RPCI) staff, faculty, and students, who are in good health Participants confirmation of history of primary immunization series with recombinant hepatitis B (HB) vaccine (last dose at least one year prior to screening anti-HBs level assessment) Current anti-HBs levels less than or equal to 115 mIU/mL Major organ functions within acceptable medical limits as determined in routine clinical laboratory screening tests Expected availability for the duration of the study period If female, then documentation that the subject is not pregnant by an acceptable laboratory test and that the subject is using an adequate birth control method to prevent pregnancy for at least 3 months following the last immunization in the study Human immunodeficiency virus (HIV) antibody negative Ability to provide written informed consent Supervisor approval Exclusion Criteria: Known history of allergy or hypersensitivity to potato, potato components or potato products Known history of allergy to hepatitis B vaccine in any form or to components of hepatitis B vaccine Pregnancy or breast feeding Current anti-HBS levels greater than 115 mIU/mL Known immunodeficiency, cancer, or use of immunosuppressive medication including cancer chemotherapy and systemic steroids (excluding intermittent use of topical steroids) Participation in another investigational study within 30 days of enrollment in this study Known and currently active gastrointestinal disease including any of the following: peptic ulcer disease, gastroesophageal reflux, inflammatory bowel disease, diverticulitis, or pancreatitis Use of prescription medication or over the counter H2 blockers or proton pump inhibitors (PPIs) for any of the above diseases regularly and within 1 month of enrollment Diagnosis of insulin-dependent diabetes or multiple sclerosis Significant laboratory abnormality which suggests dysfunction of hematological, renal, or hepatic systems Known history of hepatitis B infection in the past Temporary exclusion for mild upper respiratory illness, gastrointestinal illness, or other febrile episode that is expected and documented to resolve
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Renuka Iyer
    Organizational Affiliation
    Roswell Park Cancer Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Edible Hepatitis B Vaccine Therapy in Healthy Participants Who Have Undergone Previous Vaccination

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