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

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