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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Healthy, no Evidence of Disease	Biological: hepatitis B antigen peptide; Other: placebo; Other: immunoenzyme technique	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Prevention
Official Title:	Pilot Study Testing the Immunogenic Efficacy of an Edible Vaccine for Hepatitis B in Healthy Volunteers
Study Start Date :	February 2013
Estimated Primary Completion Date :	December 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Arm I; Participants consume placebo HBV-EPV on days 0, 14, 28, and 56.	Other: placebo; Given orally (PO); Other Name: PLCB Other: immunoenzyme technique; Correlative studies; Other Name: immunoenzyme techniques
Experimental: Arm II; 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; Given PO; Other Names: HBsAg; peptide, hepatitis B antigen Other: placebo; Given orally (PO); Other Name: PLCB Other: immunoenzyme technique; Correlative studies; Other Name: immunoenzyme techniques
Experimental: Arm III; Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14.	Biological: hepatitis B antigen peptide; Given PO; Other Names: HBsAg; peptide, hepatitis B antigen Other: placebo; Given orally (PO); Other Name: PLCB Other: immunoenzyme technique; Correlative studies; Other Name: immunoenzyme techniques
Experimental: Arm IV; Participants consume HBV-EPV expressing HBsAg on days 0, 14, 28, and 56.	Biological: hepatitis B antigen peptide; Given PO; Other Names: HBsAg; peptide, hepatitis B antigen Other: immunoenzyme technique; Correlative studies; Other Name: immunoenzyme techniques

Outcome Measures

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Primary Outcome Measures :

1. Maximum fold increase in anti-HBsAg titer levels relative to baseline levels [ Time Frame: Over 70 days ]

Secondary Outcome Measures :

1. Absolute maximum response [ Time Frame: On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114 ]
2. Area under the curve [ Time Frame: On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114 ]
3. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Renuka Iyer	Roswell Park Cancer Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:	NCT01292421 History of Changes
Other Study ID Numbers:	I 124207; NCI-2011-00064 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted:	February 9, 2011
Last Update Posted:	January 30, 2013
Last Verified:	January 2013

Additional relevant MeSH terms:

Hepatitis B; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases	Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases