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).
Name: A/H5N1
Description: A/H5N1 Low DoseType: BiologicalGroup 1: 30 µg HA, no LT patch Group 2: 30 µg HA + 50 µg LT patch Group 3: 30 µg HA + 100 µg LT patch
Name: A/H5N1
Description: A/H5N1 High DoseType: BiologicalGroup 4: 45 µg HA, no LT patch Group 5: 45 µg HA + 50 µg LT patch Group 6: 45 µg HA + 100 µg LT patch
Name: LT Adjuvant Patch
Description: LT Adjuvant Patch Low DoseType: BiologicalGroup 2: 30 µg HA + 50 µg LT patch Group 5: 45 µg HA + 50 µg LT patch
Name: LT Adjuvant Patch
Description: LT Adjuvant Patch High DoseType: BiologicalGroup 3: 30 µg HA + 100 µg LT patch Group 6: 45 µg HA + 100 µg LT patch
Description: Seroconversion is defined as either 1) baseline HI titer < 1:10 and a post-vaccination HI titer ≥ 1:40, or 2) baseline HI titer ≥ 1:10 and a minimum four-fold rise. Seroprotection is defined as a post-vaccination HI antibody titer ≥ 1:40.
Measure: Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28. Time: Day 28Description: The percent of subjects achieving seroconversion for HI antibody titer should meet or exceed 40% The percent of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% Geometric mean titer (GMT) fold increase > 2.5
Measure: Evaluate Treatment Group HI Responses Against US FDA Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines (May 2007) and EMA CPMP/BWP/214/96 Criteria for Immunogenicity Time: Day 28Allocation: Randomized
Parallel Assignment
There is one SNP
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. --- R192G ---