A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants

Exclusion Criteria

• •1. Presence of a fever ≥ 38.0°C measured orally at baseline, on Day 1 prior to vaccination. (Assessment may be repeated once during screening period).
• •2. 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 once during screening period).
• •3. Participants who have received antipyretic/analgesic medications within 24 hours prior to the intended vaccine administration.
• •4. Positive human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) tests at the screening visit.
• •5. History of hypersensitivity or allergic reaction to any component of the investigational vaccine, including but not limited to fish gelatin.
• •6. History of serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
• •7. Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including the 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.
• •8. History of significant pregnancy-related complications during this pregnancy, including but not limited to pre-eclampsia, eclampsia, or gestational diabetes unless a full resolution is documented.
• •9. Cancer, or treatment for cancer, within the past 3 years (excluding fully treated and resolved basal cell carcinoma or squamous cell carcinoma).
• •10. Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus type 1 or 2.
• •11. 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:
• •a. Any history of:
• •i. Malignancy
• •ii. Malabsorption
• •iii. Pancreatobiliary disorders
• •iv. Inflammatory bowel disease
• •v. Irritable bowel disease
• •vi. Hiatal hernia
• •vii. Surgical resection
• •b. History of diagnosis or treatment in past 5 years of:
• •i. Esophageal or gastric motility disorder
• •ii. Gastroesophageal reflux disease (GERD) - Will allow for participants with a history of pregnancy-related GERD if fully resolved for \>3 months and no other history of GERD diagnosis
• •iii. Peptic ulcer
• •iv. Cholecystectomy
• •12. Any condition that resulted in the absence or removal of the spleen.
• •13. History of any form of angioedema.
• •14. Diagnosed bleeding disorder or significant bruising or bleeding difficulties that could make blood draws problematic.
• •15. History of GI bleeding including hematochezia (blood in stool) or melena (black stool).
• •16. Any significant hospitalization within the last year which in the opinion of the investigator or sponsor could interfere with study participation.
• •17. Any of the following history or conditions that may lead to a higher risk of clotting events and/or thrombocytopenia:
• •1. Family or personal history of bleeding or thrombosis
• •2. History of heparin-related thrombotic events, and/or receiving heparin treatments
• •3. History of autoimmune or inflammatory disease
• •4. Presence of any of the following conditions known to increase the risk of thrombosis within 6 months prior to screening:
• •i. Recent surgery other than fully healed cesarean delivery or excision/ biopsy of cutaneous lesions
• •ii. Immobility (confined to bed or wheelchair for 3 or more successive days)
• •iii. Head trauma with loss of consciousness or documented brain injury
• •iv. Receipt of anticoagulants for prophylaxis of thrombosis
• •v. Recent clinically significant infection including hospitalization for COVID-19 related illness
• •18. 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.
• •19. Receipt of a licensed vaccine (including any COVID-19 vaccines under Emergency Use Authorization) within 14 days prior to study drug dose or planned administration during the study active period.
• •20. 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.
• •21. Use of medications known to affect the immune function (including but not limited to systemic corticosteroids, leukotriene modifiers, and Janus kinase \[JAK\] inhibitors) within 2 weeks before study drug administration or planned use during the active study period.
• •22. Daily use of nonsteroidal anti-inflammatory drugs within 7 days prior to study drug administration or planned use during the active study period.
• •23. Donation or receipt of blood or blood products within 30 days prior to study drug administration or planned donation during the active study period.
• •24. Participating in any clinical trial with another investigational product within 30 days prior to the first trial visit or intend to participate in another clinical trial at any time during the conduct of this trial.
• •25. Are first-degree relatives of individuals involved in trial conduct.
• •26. Positive urine drug screen for drugs of abuse at screening.
• •27. Positive alcohol test at screening or baseline.
• •28. History of drug, alcohol, or chemical abuse within 1 year of screening.