Norovirus Challenge Study

Inclusion Criteria

• Male or female between the ages of 18 - 49 years, inclusive
• Able to give written informed consent
• Healthy, as determined by the principal investigator (PI) or PI in consultation with the research monitor and Sponsor Healthy = No clinically significant health concerns or medical illness, as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratories (complete blood count (CBC), chemistry and urinalysis)
• Comprehension of the study requirements with ability and willingness to complete all assessments and comply with confinement period post viral challenge, and all scheduled visits and contacts
• Confirmed blood type (A or O)
• Demonstrated to be H type-1 antigen secretor positive (by saliva test)
• Body mass index between 17 and 35 kg/m2, inclusive, at Screening
• Female participants must have a negative pregnancy test at pre-vaccination and pre-challenge and fulfill one of the following Criteria:
• At least one year post-menopausal;
• Surgically sterile;
• Use of oral, implantable, transdermal or injectable contraceptives for 30 days prior to immunization and until 60 days after challenge;

i. A reliable form of contraception must be approved by the Investigator (eg, double barrier method, Depo-Provera, intrauterine device, Norplant, oral contraceptives, contraceptive patches) d. Not be sexually active (abstinent) or in a same sex relationship (must be discussed with site staff and documented)

• Male subjects must agree not to father a child or donate sperm, as well as to use contraception/barrier (a male condom) or be abstinent from heterosexual intercourse, from vaccination through the active period (Day 57)

Exclusion Criteria

• Administration/use of any investigational drug or device 30 days prior to vaccination through the active period (Day 57)
• Administration of any licensed vaccine within 30 days prior to vaccination or planned use of the above stated during the active period (through Day 57)
• Presence of a significant medical condition, which, in the opinion of the investigator, precludes participation in the study. Significant medical condition = for example, psychiatric conditions, or gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or gastroesophageal reflux disease, inflammatory bowel disease, alcohol or illicit drug abuse/dependency, or other laboratory abnormalities
• Laboratory values outside the range of normal for platelet counts and the following coagulation tests: prothromibin time test (PT/INR), activated partial thromboplastine time test (aPTT) and fibrinogen
• Any of the following history or conditions that may lead to higher risk of clotting events and/or thrombocytopenia:
• Family or personal history of bleeding or thrombosis
• History of heparin-related thrombotic events, and/or receiving heparin treatments
• History of autoimmune or inflammatory disease
• Presence of any of the following conditions known to increase risk of thrombosis within 6 months prior to screening:
• Recent surgery other than removal/biopsy of cutaneous lesions
• Immobility (confined to bed or wheelchair for 3 or more successive days)
• Head trauma with loss of consciousness or documented brain injury
• Receipt of anticoagulants for prophylaxis of thrombosis
• Recent clinically significant infection
• Any one of the following ECG findings within 45 days prior to vaccination:

Exclusionary ECG findings:

• QTc F (interval duration > 450 msec (male) or > 470 msec (female)
• QRS interval greater than 120 msec
• PR interval greater than 220 msec
• Clinically significant ST-T wave changes or pathologic Q waves
• History of cancer or cancer treatment within past 3 years (excluding basal cell or squamous cell carcinomas)
• Presence of immunosuppression or medical condition possibly associated with impaired immune responsiveness, including diabetes mellitus or angioedema
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