LT Vaccine Patch Self-Administration Study
Condition: Prevention of Travelers' Diarrhea
MeSH terms: Diarrhea
Intervention: heat-labile enterotoxin of E. coli (LT)
Intervention description: 37.5ug patch applied on either the deltoid or the thigh
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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.