Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
500 participants
INTERVENTIONAL
2009-05-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1: 30 µg HA, no LT patch
A/H5N1 Vaccine 30 µg HA i.m. on Day 0
A/H5N1
A/H5N1 Low Dose
Group 2: 30 µg HA + 50 µg LT patch
A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
A/H5N1
A/H5N1 Low Dose
LT Adjuvant Patch
LT Adjuvant Patch Low Dose
Group 3: 30 µg HA + 100 µg LT patch
A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
A/H5N1
A/H5N1 Low Dose
LT Adjuvant Patch
LT Adjuvant Patch High Dose
Group 4: 45 µg HA, no LT patch
A/H5N1 Vaccine 45 µg HA i.m. on Day 0
A/H5N1
A/H5N1 High Dose
Group 5: 45 µg HA + 50 µg LT patch
A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
A/H5N1
A/H5N1 High Dose
LT Adjuvant Patch
LT Adjuvant Patch Low Dose
Group 6: 45 µg HA + 100 µg LT patch
A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
A/H5N1
A/H5N1 High Dose
LT Adjuvant Patch
LT Adjuvant Patch High Dose
Interventions
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A/H5N1
A/H5N1 Low Dose
A/H5N1
A/H5N1 High Dose
LT Adjuvant Patch
LT Adjuvant Patch Low Dose
LT Adjuvant Patch
LT Adjuvant Patch High Dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.)
18 Years
49 Years
ALL
Yes
Sponsors
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Department of Health and Human Services
FED
Intercell USA, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Sheldon, MD
Role: PRINCIPAL_INVESTIGATOR
Miami Research Associates
Locations
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Advanced Clinical Research Institute
Anaheim, California, United States
Solano Clinical Research
Vallejo, California, United States
Miami Research Associates
Miami, Florida, United States
Accelovance
South Bend, Indiana, United States
Johnson County Clinical Trials
Lenexa, Kansas, United States
Jean Brown Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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HHSO100200700031C
Identifier Type: -
Identifier Source: secondary_id
PLA201
Identifier Type: -
Identifier Source: org_study_id