Open-label Study to Assess Immunogenicity and Safety of a Vaccine Enhancement Patch When Administered With 2 Doses of H5N1 Vaccine

Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered IM but followed by the topical application of a VEP at the vaccination site. Group 4 will receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of a VEP at the vaccination site.

The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)


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