Phase 1 Norwalk Vaccine Study

Exclusion Criteria

• •1. History of any of the following medical illnesses
• •* Chronic rhinitis, runny nose, sneezing
• •* Clinically significant nose bleed within the last year
• •* Diabetes
• •* Cancer
• •* Heart disease (hospitalization for a heart attack, arrhythmia, or syncope)
• •* Unconsciousness (other than a single brief "concussion")
• •* Seizures (other than febrile seizures as a child \<5 years old)
• •* Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis)
• •* Asthma requiring treatment with inhaler or medication
• •* Any current illness requiring daily medication other than vitamins, birth control, or anti-depressant
• •2. Blood Type B or AB, regardless of Rh + or -
• •3. Allergies or hypersensitivity to chitosan, shrimp, other shellfish or any component of the vaccine, adjuvant/excipients or placebo
• •4. History of nasal surgery of any type (including tonsilectomy/adenoidectomy)
• •5. Any clinically significant abnormality detected on physical examination, including:
• •* Murmur (other than a functional murmur)
• •* Focal neurological abnormality
• •* Hepatosplenomegaly
• •* Lymphadenopathy
• •* Jaundice
• •6. Hypertension (BP \> 140/90 mm Hg on two separate days)
• •7. Any lab abnormality, as listed below:
• •* Neutrophils (WBC) outside the normal range
• •* Hemoglobin outside the normal range (may be repeated once if outside this limit)
• •* Platelet count outside the normal range (may be repeated once if outside this limit)
• •* Creatinine outside the normal range (may be repeated once if outside this limit)
• •* Glucose \> upper limit of normal (may be repeated once if outside this limit)
• •* AST or ALT outside the normal range (may be repeated once if outside this limit)
• •* Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen
• •8. For women, positive serum pregnancy test within 7 days and urine pregnancy test within 24 hours of administering either dose of Norwalk VLP Vaccine, adjuvant/excipients or placebo
• •9. Nursing mother
• •10. Temperature \> 38.0 degrees C (100.4 degrees F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 3 days of administration of Norwalk VLP Vaccine, adjuvant/excipients or placebo
• •11. Previous participation in a study of Norovirus vaccines
• •12. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
• •13. Receipt of an investigational vaccine or drug within 28 days before administration of Norwalk VLP Vaccine, adjuvant/excipients or placebo
• •14. Other condition that in the clinical judgment of the investigator would jeopardize the safety or rights of a subject participating in the trial, would render the subject unable to comply with the protocol or would interfere with the evaluation of the vaccine
• •15. Failure to pass written examination about this study (70% correct answers required to pass)\[A University of Maryland site-specific exclusion criterion\]