A/H5N1 Dose Ranging Study With Adjuvant Patch

This is an interventional treatment trial for Pandemic Influenza focused on measuring Avian, Pandemic, Influenza, A/H5N1 Read More

Inclusion Criteria:

• Healthy adult males or females 18-49 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 each vaccination with understanding (through Informed Consent process) to not become pregnant and 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:

• 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 egg protein allergy
• Known allergies to adhesives
• Known disturbance of coagulation
• Participated in research involving investigational product within 45 days before planned date of first 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 first vaccination
• 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 travelers' diarrhea in the last 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 illness
• Previous vaccination with a pandemic candidate 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 first vaccination
• Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to first vaccination
• Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, 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(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
• Hirsute (significant amount of hair) at vaccination area(s)
• Artificial tanning (UV radiation) over the duration of the study including the screening period
• 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
• Suspicion of or recent history of (within one year of planned vaccination) 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 Guillain Barré syndrome) in the six weeks following a previous influenza vaccination
• Medical history of achlorhydria
• Employee of the investigational site
• History of employment in bird or poultry industries or considerable exposure to birds (e.g. poultry or bird veterinarians, bird breeders, poultry butchers and/or cullers, etc.)