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

Exclusion Criteria

• •Health
• •1. 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.
• •2. Clinically significant abnormalities on physical examination
• •3. 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)
• •4. 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
• •5. Participation in research involving another investigational product 30 days before the planned date of first vaccination until the last study safety visit.
• •6. Positive blood test for HIV-1 (the human immunodeficiency virus and cause of AIDS)
• •7. Positive blood test for hepatitis B surface antigen (HBsAG; the virus causing hepatitis B)
• •8. Positive blood test for anti-HCV antibody (the virus causing hepatitis C)
• •9. Clinically significant abnormalities on basic laboratory screening
• •10. Presence of significant unexplained laboratory abnormalities that in the opinion of the PI may potentially confound the analysis of the study results Research Specific
• •11. Regular use (weekly or more often) of anti-diarrheal, anti-constipation, or antacid therapy
• •12. Abnormal bowel habits as defined by fewer than 3 stools per week or more than 3 loose/liquid stools per day
• •13. Personal or family history of inflammatory arthritis
• •14. Personal history of irritable bowel syndrome
• •15. Positive blood test for HLA-B27
• •16. History of allergy to any vaccine
• •17. History of allergy to alum
• •18. History of Guillain-Barré Syndrome or other neuroimmunological disorders Prior Exposure to Campylobacter
• •19. History of travelers' diarrhea or residence (\> 2 months) in the past 3 years in a country with potentially higher Campylobacter rates to include Africa, South America, Central America, and Asia (except Japan).
• •20. Occupation involving handling of Campylobacter bacteria or vaccine products currently or in the past 3 years.
• •21. History of microbiologically confirmed Campylobacter infection.
• •22. Received previous experimental Campylobacter vaccine or live Campylobacter challenge.