Dose Range Evaluation of Norovirus Challenge Pool (GII.4, CIN-1)

You may not qualify if:

• Expected to be noncompliant with study procedures or planning to move within the anticipated total duration of the study (180 days after challenge)
• Pregnant or breastfeeding
• HIV positive (by history or screening antibody test)
• Hepatitis B positive (by history or a positive hepatitis B surface antigen)
• Hepatitis C positive (by history or a positive antibody to hepatitis C virus)
• Norovirus GII.4 serum antibody screening titer of \> 1:1600
• Clinically significant findings on history or physical examination
• Temperature \>38.00C, resting heart rate \>100/beats per minute or \<55/beats per minute, systolic blood pressure \>140, diastolic blood pressure \>90, systolic blood pressure \<90, respiratory rate \>16/min. If heart rate \<55 beats per minute and investigator determines that this is not clinically significant and heart rate increases \> 55 beats per minute on moderate exercise (two flights of stairs), subject will not be excluded. Vital signs may be repeated at screening.
• Clinically significant history of diseases or treatments that may affect the immune system's function such as a past history of cancer, receipt of chemotherapy or radiation therapy, or autoimmune diseases (exception; a history of basal cell or squamous cell carcinoma in remission without treatment for more than 5 years prior to study entry)
• Receipt of systemic corticosteroids for greater than 7 days within the past six months
• Clinically abnormal screening electrocardiogram (ECG) defined as pathologic Q waves and significant ST-T wave changes: criteria for left ventricular hypertrophy; and any non-sinus rhythm excluding isolated premature atrial contractions
• Clinically significant respiratory disease, endocrine disease, liver disease, renal disease, or neurological disease
• History of malabsorption or maldigestion disorder (e.g. celiac sprue), major gastrointestinal (GI) surgery, or any other chronic GI disorders that would interfere with the study
• Clinically significant abnormalities of the health screening laboratory work
• Use of antibiotics within 7 days prior to entry into the inpatient facility (Day -1)
• +19 more criteria