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

NCT ID: NCT01292421

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28

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.

Conditions

Healthy, no Evidence of Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arm I

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given orally (PO)

immunoenzyme technique

Intervention Type: OTHER

Correlative studies

Arm II

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

Group Type: EXPERIMENTAL

hepatitis B antigen peptide

Intervention Type: BIOLOGICAL

Given PO

placebo

Intervention Type: OTHER

Given orally (PO)

immunoenzyme technique

Intervention Type: OTHER

Correlative studies

Arm III

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

Group Type: EXPERIMENTAL

hepatitis B antigen peptide

Intervention Type: BIOLOGICAL

Given PO

placebo

Intervention Type: OTHER

Given orally (PO)

immunoenzyme technique

Intervention Type: OTHER

Correlative studies

Arm IV

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

Group Type: EXPERIMENTAL

hepatitis B antigen peptide

Intervention Type: BIOLOGICAL

Given PO

immunoenzyme technique

Intervention Type: OTHER

Correlative studies

Interventions

hepatitis B antigen peptide

Given PO

Intervention Type: BIOLOGICAL

placebo

Given orally (PO)

Intervention Type: OTHER

immunoenzyme technique

Correlative studies

Intervention Type: OTHER

Other Intervention Names

HBsAg; peptide, hepatitis B antigen; PLCB; immunoenzyme techniques

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renuka Iyer

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Other Identifiers

NCI-2011-00064

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 124207

Identifier Type: -

Identifier Source: org_study_id