Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

Inclusion criteria

• A female or male 18-64 (inclusive) years of age;
• In good health as determined by medical history and screening exam;
• Females who are post-menopausal, surgically sterile, or have a negative serum/urine pregnancy test at Day 0 and agree not to become pregnant for the duration of study.

Exclusion criteria

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