Table 1.

Sample Inclusion/Exclusion Criteria

Inclusion Criteria
• Healthy, adult, male or female, age (generally 18–50 or 18–45 y)	• Women: Negative pregnancy test with understanding to not become pregnant during the study
• Signed informed consent document.
• Available for inpatient study and for outpatient follow-up visits	• Completion and review of comprehension test (achieved >70% accuracy)
Exclusion Criteria
• Clinically significant medical or psychiatric problem by history	• Chronic use of antidiarrheal, anticonstipation, or antacid therapy
• Clinically significant abnormalities on physical examination or screening labs	• History of irritable bowel syndrome or abnormal stool pattern
• Use of steroids or other immunosuppressive and/or immunomodulatory drugs	• Personal or family history of inflammatory arthritis
• Currently pregnant or nursing	• Positive blood test for HLA-B27
• Participation in research involving another investigational product within 30 d before enrollment and during the duration of the study	• History of Shigella infection (exclusion duration protocol specific)
• Positive and confirmatory blood test for HBsAg, HCV, HIV-1	• Received previous experimental Shigella vaccine or live Shigella challenge (exclusion duration protocol specific)
• Clinically significant abnormalities on basic laboratory screening	• Travel to countries with symptoms of travelers' diarrhea where Shigella or other enteric infections are endemic within 6 mo prior to enrollment
• Immunosuppressive illness or IgA deficiency (serum IgA <7 mg/dL or limit of detection of assay)	• Occupation involving handling of Shigella bacteria
• Current alcohol or drug dependence	• Serum IgG titer ≥2500 to Shigella LPS [39, 40]
• Current or prior history of inflammatory bowel disease	• Use of antibiotics within 7 d prior to challenge

Abbreviations: HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus; HIV-1, human immunodeficiency virus type 1; IgA, immunoglobulin A; IgG, immunoglobulin G; LPS, lipopolysaccharide.