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

Inclusion criteria

• ✓. Healthy adults between the ages of 18 and 49 years
• ✓. Willing and able to provide written informed consent
• ✓. Able to comply with all study procedures
• ✓. Have a serum antibody titer of \< 1:1600 to the GII.4 challenge strain of Norovirus as measured by ELISA
• ✓. Female subjects of childbearing potential must have negative urine pregnancy tests, at screen and prior to challenge
• ✓. Female subjects must be of non-childbearing potential, or if of childbearing potential (as determined by investigator) must be practicing abstinence or using an effective licensed method of birth control (e.g. oral contraception; diaphragm or condom in combination with contraceptive jelly, cream, or foam; intrauterine contraceptive device, or hormonal devices/injections (for example, NORPLANT® or DEPO-PROVERA®) from screening through one month after completing inpatient stay.
• ✓. Have normal screening laboratories for SGPT (ALT), creatinine, sodium, potassium, total white blood cell count (WBC), hemoglobin, neutrophils, lymphocytes, platelets, urine protein, urine glucose and urine RBCs (see table below) as well as negative stool culture for known bacterial pathogens and stool evaluation for parasites.
• ✓. For challenged subjects: Be secretor positive for HBGA binding by assay of their saliva. For placebo recipients: Be secretor negative for HBGA binding by assay of their saliva.