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

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