Clinical trial NCT01353534 (phase 1/phase 2, status: completed)
Conditions: healthy
ICD codes: Z76.3, Z76.2
Drugs: vaccine enhancement patch
SMILES: [O-][N+](=O)OCC(CO[N+]([O-])=O)(CO[N+]([O-])=O)CO[N+]([O-])=O
Eligibility criteria:

        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 at all in-clinic visits with understanding to
             not become pregnant over the duration of the study.

        Exclusion Criteria:

          -  Clinically significant laboratory abnormalities at screening

          -  abnormalities at physical examination

          -  known allergies to any component of the A/H5N1 antigen

          -  known egg protein allergy

          -  known allergies to adhesives

          -  known coagulation disorders

          -  use of any anticoagulant medication within 30 days prior to vaccination or planned
             usage during the study period

          -  participated in research involving investigational product within 30 days before
             planned date of vaccination or planned participation during study period

          -  donated or received blood or blood products such as plasma within the three months
             before planned date of vaccination or planned donation or use during the study period

          -  received or planned receipt of seasonal influenza vaccine during the study period

          -  received any licensed vaccines within 2 weeks (inactivated vaccines) or 4 weeks (live
             vaccines) prior to planned date of vaccination

          -  planned receipt of any licensed vaccine during the first 42 days on study

          -  previous or planned vaccination with any vaccine containing an oil in water emulsion
             adjuvant

          -  previous or planned vaccination with pandemic vaccine against A/H5N1 or previous
             proven contact with A/H5N1 wild type virus

          -  ever received investigational enterotoxigenic E. coli LT, or LT (R192G) or NasalFlu,
             Berna Biotech, Ltd. Ever received cholera toxin or vaccine

          -  Recent or regular use of oral, topical or injected steroid medications within 30 days
             prior to vaccination or planned use during the study period.

          -  Use of immunosuppressive systemic steroid medications including inhaled steroids
             within three months prior to vaccination or planned use during the study period

          -  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 at vaccination area

          -  artificial tanning over the duration of the study including the screening period

          -  visible tattoos or marks at the vaccination area that would prevent appropriate
             dermatologic monitoring of the vaccination site

          -  fever greater than or equal to 38.0°C at the time of planned vaccination

          -  suspicion of or recent history of alcohol or substance abuse

          -  women who are pregnant or breastfeeding

          -  acute illness at screening or at the time of planned vaccination

          -  ever had a serious reaction to prior influenza vaccination

          -  developed a neurological disorder following a previous influenza vaccination or have
             any acute and evolving neurological disorder

          -  employee of the investigational site or sponsor

          -  history of employment in bird or poultry industries or considerable exposure to birds