Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines

Exclusion Criteria

• •The participants must be excluded from participating in the study if they meet any of the following:
• •Medical Conditions
• •1. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline
• •2. Cancer, or received treatment for cancer, within past 3 years (excluding basal cell carcinoma or squamous cell carcinoma)
• •3. Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus 1 and 2
• •4. History of irritable bowel disease or other inflammatory digestive or gastrointestinal condition that could affect the distribution/safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine.
• •Such conditions may include but are not limited to:
• •1. Esophageal Motility Disorder
• •2. Malignancy
• •3. Malabsorption
• •4. Pancreaticobiliary disorders
• •5. Irritable bowel syndrome
• •6. Inflammatory Bowel Disease
• •7. Surgical Resection
• •8. GERD
• •9. Hiatal Hernia
• •10. Peptic Ulcer (History of cholecystectomy is not exclusionary)
• •5. History of any form of angioedema
• •6. History of serious reactions to any vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain
• •7. Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic
• •8. Any condition that resulted in the absence or removal of the spleen
• •9. Acute disease within 72 hours prior to vaccination defined as the presence of a moderate or severe illness (as determined by the Investigator through medical history and physical exam). (Assessment may be repeated during screening period.)
• •10. Presence of a fever ≥ 38oC measured orally at baseline (Assessment may be repeated during screening period)
• •11. Any significant hospitalization within the last year which in the opinion of the Investigator or Sponsor could interfere with study participation.
• •12. Any other condition that in the clinical judgment of the investigator would jeopardize the safety or rights of a participant taking in the study, would render the participant unable to comply with the protocol or would interfere with the evaluation of the study endpoints Diagnostic Assessments
• •13. Positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) tests at the screening visit
• •14. Positive urine drug screen for drugs of abuse at screening
• •15. Positive breath or urine alcohol test at screening and baseline Prior/Concurrent Therapy
• •16. Receipt of a licensed vaccine within 14 days prior to baseline vaccination or planned administration during the study active period (4 weeks post each study vaccination).
• •17. Use of antibiotics, proton pump inhibitors, H2 blockers or antacids within 7 days prior to study drug administration or planned use during the active study period
• •18. Use of medications known to affect the immune function (e.g., systemic corticosteroids and others) within 2 weeks before study drug administration or planned use during the active study period
• •19. Daily use of nonsteroidal anti-inflammatory drugs within 7 days prior to study drug administration or planned use during the active study period
• •20. Administration of any investigational vaccine, drug or device within 8 weeks preceding study drug administration (Day 1), or planned use within the duration of the study Other Exclusions
• •21. Donation or use of blood or blood products within 30 days prior to study drug administration or planned donation during the active study period
• •22. History of drug, alcohol or chemical abuse within 1 year of screening
• •23. History of hypersensitivity or allergic reaction to any component of the investigational vaccine, including but not limited to fish gelatin