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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study Testing the Immunogenic Efficacy of an Edible Vaccine for Hepatitis B in Healthy Volunteers

Conditions
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Healthy, no Evidence of Disease

Intervention / Treatment
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* Biological: hepatitis B antigen peptide
* Other: placebo
* Other: immunoenzyme technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm I<br>Participants consume placebo HBV-EPV on days 0, 14, 28, and 56. | Other: placebo<br>* Given orally (PO)<br>* Other names: PLCB;Other: immunoenzyme technique<br>* Correlative studies<br>* Other names: immunoenzyme techniques;|
| Experimental: Arm II<br>Participants consume HBV-EPV expressing HBsAg on days 0 and 28 and placebo HBV-EPV on days 14 and 56. | Biological: hepatitis B antigen peptide<br>* Given PO<br>* Other names: peptide, hepatitis B antigen;Other: placebo<br>* Given orally (PO)<br>* Other names: PLCB;Other: immunoenzyme technique<br>* Correlative studies<br>* Other names: immunoenzyme techniques;|
| Experimental: Arm III<br>Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14. | Biological: hepatitis B antigen peptide<br>* Given PO<br>* Other names: peptide, hepatitis B antigen;Other: placebo<br>* Given orally (PO)<br>* Other names: PLCB;Other: immunoenzyme technique<br>* Correlative studies<br>* Other names: immunoenzyme techniques;|
| Experimental: Arm IV<br>Participants consume HBV-EPV expressing HBsAg on days 0, 14, 28, and 56. | Biological: hepatitis B antigen peptide<br>* Given PO<br>* Other names: peptide, hepatitis B antigen;Other: immunoenzyme technique<br>* Correlative studies<br>* Other names: immunoenzyme techniques;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum fold increase in anti-HBsAg titer levels relative to baseline levels |  | Over 70 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute maximum response |  | On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114 | 
| Area under the curve |  | On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114 | 
| Proportion of two-fold responses in anti-HBsAg titer levels |  | On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114 |