Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

Exclusion Criteria

• •1. Abnormalities at physical exam \[as determined by the Toxicity Grading Scale (Grade 1-4)\];
• •2. Laboratory abnormalities \[as determined by the Toxicity Grading Scale (Grade 1 4)\] at screening;
• •3. Participated in research involving investigational product within 30 days before planned date of first vaccination;
• •4. Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd;
• •5. Women who are pregnant or breastfeeding;
• •6. Clinically significant underlying enteric, pulmonary, cardiac or renal disease;
• •7. Current seizure disorder;
• •8. Current use of immunosuppressive therapy (inhaled steroids are allowed);
• •9. Known or suspected alcohol abuse or illicit drug use within the last year;
• •10. Positive Serology for HIV-1, HIV-2, HbsAg, or HCV;
• •11. Known allergies to any component of the vaccine including adhesives;
• •12. An employee of the study site;
• •13. An employee of Intercell (global) or an immediate family member;
• •14. Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites;
• •15. Receipt of any routine vaccinations within 7 days prior to, or following, the date of planned study vaccinations.