LT Vaccine Patch Self-Administration Study

A Phase 2, Randomized, Open-Label Study to Compare the Immunogenicity and Safety of a Self-Administered LT Vaccine Patch With an LT Vaccine Patch Administered by a Clinician

To evaluate the immune responses achieved following self-administered heat-labile enterotoxin of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses achieved by clinician-administered vaccination.

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:

• Healthy adult males or females 18-64 years of age with signed Informed Consent.
• Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant over the duration of the study, and must agree to employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD.

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for participation in the study:

• Laboratory abnormalities [as determined by the Toxicity Grading Scale (grade 1-4)] at laboratory screening
• Abnormalities at physical examination [as determined by the Toxicity Grading Scale (grade 1-4)]
• Known allergies to any component of the vaccine
• Known allergies to adhesives
• Participated in research involving investigational product within 30 days before planned date of first vaccination
• Donated blood or blood products such as plasma within the past 30 days
• Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd
• Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™)
• History of traveler's diarrhea in the previous two years
• History of abdominal surgery (excluding C-Section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal (GI) illness
• Positive serology for HIV-1, HIV-2, HBsAg, or HCV
• Medical history of acute or chronic skin disease at vaccination area(s)
• Active skin allergy
• Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation
• Excessively hirsute at the vaccination area(s) that would interfere with patch adhesion in the opinion of the Investigator
• Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s)
• Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination
• Women who are pregnant or breastfeeding
• Acute illness at screening or at baseline; or
• Employee of the investigational site.