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A/H5N1/LT Dose Ranging Study

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ClinicalTrials.gov Identifier: NCT00908687
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : March 13, 2014
Last Update Posted : March 13, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Pandemic Influenza Biological: A/H5N1 Biological: LT Adjuvant Patch Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Blinded, LT Dose-ranging Study to Assess the Immunogenicity and Safety of Different Doses of LT Adjuvant Patch Administered in Conjunction With Different Doses of Inactivated Influenza A/H5N1 Vaccine in Healthy Adults
Study Start Date : May 2009
Primary Completion Date : January 2010
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group 1: 30 µg HA, no LT patch
A/H5N1 Vaccine 30 µg HA i.m. on Day 0
Biological: A/H5N1
A/H5N1 Low Dose
Experimental: 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
Biological: A/H5N1
A/H5N1 Low Dose
Biological: LT Adjuvant Patch
LT Adjuvant Patch Low Dose
Experimental: 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
Biological: A/H5N1
A/H5N1 Low Dose
Biological: LT Adjuvant Patch
LT Adjuvant Patch High Dose
Experimental: Group 4: 45 µg HA, no LT patch
A/H5N1 Vaccine 45 µg HA i.m. on Day 0
Biological: A/H5N1
A/H5N1 High Dose
Experimental: 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
Biological: A/H5N1
A/H5N1 High Dose
Biological: LT Adjuvant Patch
LT Adjuvant Patch Low Dose
Experimental: 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
Biological: A/H5N1
A/H5N1 High Dose
Biological: LT Adjuvant Patch
LT Adjuvant Patch High Dose


Outcome Measures

Primary Outcome Measures :
  1. Assess the Proportion of Subjects in Each Dose Group Achieving Seroconversion and Seroprotection for HI Antibody Titer Through Day 28. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Safety of A/H5N1 Vaccine IM Injection With and Without an LT Adjuvant Patch [ Time Frame: 6 months ]
  2. Safety of a 100μg LT Patch [ Time Frame: 6 months ]
  3. 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 Frame: Day 28 ]
    • 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


Other Outcome Measures:
  1. Adjuvanticity Evaluation: Compare HI Immune Responses Achieved by Antigen and Adjuvant Combinations With Antigen Alone Groups. [ Time Frame: 6 months ]
  2. Cross-clade HI Antibody Titer Measurement: Compare the Heterologous HI Antibody Responses to the A/Indonesia/05/2005 (Clade 2.1) Strain of the H5N1 Virus. [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908687


Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Solano Clinical Research
Vallejo, California, United States, 94589
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
United States, Indiana
Accelovance
South Bend, Indiana, United States, 46601
United States, Kansas
Johnson County Clinical Trials
Lenexa, Kansas, United States, 66219
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Intercell USA, Inc.
Department of Health and Human Services
Investigators
Principal Investigator: Eric Sheldon, MD Miami Research Associates
More Information

Additional Information:
Responsible Party: Intercell USA, Inc.
ClinicalTrials.gov Identifier: NCT00908687     History of Changes
Other Study ID Numbers: PLA201
HHSO100200700031C
First Posted: May 27, 2009    Key Record Dates
Results First Posted: March 13, 2014
Last Update Posted: March 13, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs