Safety Study of a Capsule-Conjugate Vaccine to Prevent Campylobacter-Caused Diarrhea

Exclusion criteria

• . Health problems affecting study participation from medical history (specifically to include chronic medical conditions such as diabetes mellitus and hypertension or any other condition requiring daily therapy that would place the volunteer at increased risk of adverse events (AEs). Study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the research monitor as appropriate.
• . Clinically significant abnormalities on physical examination
• . Use of immunosuppressive drugs, such as corticosteroids and chemotherapy, during the course of the study or immunosuppressive illness, including IgA deficiency (defined by serum IgA below level of detection)
• . Women who are pregnant or planning to become pregnant during the study period plus 3 months beyond the last vaccine dose and currently nursing women
• . Participation in research involving another investigational product 30 days before the planned date of first vaccination until the last study safety visit.
• . Positive blood test for HIV-1 (the human immunodeficiency virus and cause of AIDS)
• . Positive blood test for hepatitis B surface antigen (HBsAG; the virus causing hepatitis B)
• . Positive blood test for anti-HCV antibody (the virus causing hepatitis C)