A/H5N1/LT Dose Ranging Study

Intercell

Status and phase: Completed; Phase 2

Conditions: Pandemic Influenza

Treatments: Biological: A/H5N1; Biological: LT Adjuvant Patch

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT00908687

HHSO100200700031C

PLA201

Details and patient eligibility

About

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).

Enrollment: 500 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult male or females 18 to 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 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

• 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. 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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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500 participants in 6 patient groups

Group 1: 30 µg HA, no LT patch

Experimental group

Description:

A/H5N1 Vaccine 30 µg HA i.m. on Day 0

Treatment:

Biological: A/H5N1

Biological: A/H5N1

Group 2: 30 µg HA + 50 µg LT patch

Experimental group

Description:

A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0

Treatment:

Biological: A/H5N1

Biological: LT Adjuvant Patch

Biological: LT Adjuvant Patch

Biological: A/H5N1

Group 3: 30 µg HA + 100 µg LT patch

Experimental group

Description:

A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0

Treatment:

Biological: A/H5N1

Biological: LT Adjuvant Patch

Biological: LT Adjuvant Patch

Biological: A/H5N1

Group 4: 45 µg HA, no LT patch

Experimental group

Description:

A/H5N1 Vaccine 45 µg HA i.m. on Day 0

Treatment:

Biological: A/H5N1

Biological: A/H5N1

Group 5: 45 µg HA + 50 µg LT patch

Experimental group

Description:

A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0

Treatment:

Biological: A/H5N1

Biological: LT Adjuvant Patch

Biological: LT Adjuvant Patch

Biological: A/H5N1

Group 6: 45 µg HA + 100 µg LT patch

Experimental group

Description:

A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0

Treatment:

Biological: A/H5N1

Biological: LT Adjuvant Patch

Biological: LT Adjuvant Patch

Biological: A/H5N1