A/H5N1/LT Dose Ranging Study
Condition: Pandemic Influenza
MeSH terms: Influenza, Human
Intervention: A/H5N1; A/H5N1; LT Adjuvant Patch; LT Adjuvant Patch
Intervention description: A/H5N1 Low Dose; A/H5N1 High Dose; LT Adjuvant Patch Low Dose; LT Adjuvant Patch High Dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 500.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be
      enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this
      study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high
      dose) on Day 0 with or without a patch (low or high dose).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult male or females 18 to 49 years of age (inclusive)

          -  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 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:

          -  Clinically significant laboratory abnormalities at screening

          -  Abnormalities at physical examination [as determined by the Toxicity Grading Scale
             (grade 1-4)]

          -  Known allergies to any component of the vaccine

          -  Known egg protein allergy

          -  Known allergies to adhesives

          -  Known disturbance of coagulation

          -  Participated in research involving investigational product within 45 days before
             planned date of vaccination

          -  Donated or received blood or blood products such as plasma within the past 45 days

          -  Received any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks
             (for live vaccines) prior to planned date of vaccination

          -  Ever received investigational enterotoxigenic E. coli, or LT (R192G) or NasalFlu,
             Berna Biotech Ltd

          -  Ever received cholera toxin or vaccine (e.g. Orochol, Dukoral)

          -  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

          -  Previous vaccination with a pandemic vaccine or previous proven contact with A/H5N1
             wild type virus (contact with an individual with laboratory-confirmed A/H5N1 infection
             or contact with an animal which died as a result of A/H5N1 infection)

          -  Recent or regular use of oral, topical or injected steroid medications within 45 days
             prior to vaccination

          -  Use of immunosuppressive systemic steroid medications including inhaled steroids
             within three months prior to vaccination

          -  Comorbid conditions or treatments that are immunosuppressive, including cancer,
             diabetes, and end-stage renal disease, as determined by the Investigator

          -  Positive serology for HIV-1, HIV-2, HBsAg, or HCV

          -  History of severe atopy

          -  Medical history of acute or chronic skin disease at vaccination area

          -  Active skin allergy

          -  Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area
             including fungal infections, severe acne, active contact dermatitis, or a history of
             keloid formation

          -  Hirsute (significant amount of hair) at vaccination area

          -  Artificial tanning (UV radiation) over the duration of the study including the
             screening period

          -  Visible tattoos or marks (tattoos/scars) at the vaccination area that would prevent
             appropriate dermatologic monitoring of the vaccination site

          -  Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination

          -  Suspicion of or recent history (within one year of planned vaccination) of alcohol or
             substance abuse

          -  Women who are pregnant or breastfeeding

          -  Acute illness at screening or at baseline

          -  Ever had a serious reaction to prior influenza vaccination

          -  Developed a neurological disorder (such as Guillian Barré syndrome) in the six weeks
             following a previous influenza vaccination

          -  Medical history of achlorhydria

          -  Employee of the investigational site or sponsor

          -  History of employment in bird or poultry industries or considerable exposure to birds
             (e.g. poultry or avian veterinarians, bird breeders, poultry butchers and/or culler,
             etc.)