A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers

Exclusion criteria

• . Known clotting/bleeding issues and/or personal and family history with increased risk of bleeding or clotting.
• . 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 prior to screening and reconfirmed at baseline.
• . Cancer, or treatment for cancer or any procedure or preventive medication for cancer or to prevent recurrence, within past 3 years (excluding fully treated and resolved basal cell carcinoma or squamous cell carcinoma)
• . Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus- type 1 and 2
• . 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:
• . History of any form of angioedema
• . History of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain
• . Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.

Fold Rise in Serum - Anti-VP1 GI.1 IgG Levels by MSD Assay

Timeframe: Day 1 and Day 29