A/H5N1/LT Dose Ranging Study

Phase 2

Completed

Conditions: Pandemic Influenza

Interventions: Biological: A/H5N1
Biological: LT Adjuvant Patch

Registration Number: NCT00908687

Lead Sponsor: Intercell USA, Inc.

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 500

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.)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 5: 45 µg HA + 50 µg LT patch	LT Adjuvant Patch	A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
Group 6: 45 µg HA + 100 µg LT patch	LT Adjuvant Patch	A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
Group 3: 30 µg HA + 100 µg LT patch	A/H5N1	A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
Group 4: 45 µg HA, no LT patch	A/H5N1	A/H5N1 Vaccine 45 µg HA i.m. on Day 0
Group 1: 30 µg HA, no LT patch	A/H5N1	A/H5N1 Vaccine 30 µg HA i.m. on Day 0
Group 2: 30 µg HA + 50 µg LT patch	A/H5N1	A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
Group 2: 30 µg HA + 50 µg LT patch	LT Adjuvant Patch	A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0
Group 6: 45 µg HA + 100 µg LT patch	A/H5N1	A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
Group 3: 30 µg HA + 100 µg LT patch	LT Adjuvant Patch	A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0
Group 5: 45 µg HA + 50 µg LT patch	A/H5N1	A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0

Primary Outcome Measures

Name	Time	Method
Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28.	Day 28	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. FDA/EMEA criterion for seroconversion was to meet or exceed 40%. FDA/EMEA criterion for seroprotection was to meet or exceed 70%.

Secondary Outcome Measures

Name	Time	Method
Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch	6 months
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	Day 28

Trial Locations

Locations (6): Jean Brown Research
🇺🇸
Salt Lake City, Utah, United States
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