A/H5N1 Dose Ranging Study With Adjuvant Patch
March 13, 2012 updated by: Intercell USA, Inc.
A Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Administered With and Without an Adjuvant Patch in Healthy Adults
This is a Phase 1/2, randomized, observer-blind, placebo-controlled clinical trial. A maximum of 500 eligible subjects in 10 groups will be enrolled, randomized and vaccinated in this study. Subjects will receive an intramuscular injection of either the influenza A/H5N1 (low, medium or high dose) or placebo on Day 0 and Day 21 with or without a patch. This study will be performed in two parts.
In Part 1, an initial safety evaluation will be performed in 100 randomized subjects. A Safety Review Committee (SRC)will review all safety data, including laboratory values, through the Day 7 visit, and compare those data against Stopping Criteria. If the treatments are considered safe, Part 2 of the study will be initiated and a second vaccination will be administered to subjects in Part 1 on Day 21.
In Part 2, the remaining 400 subjects will be randomized, treated, and will follow the same visit structure and protocol-defined requirements as subjects in Part 1, without the additional laboratory safety measurements. An SRC review will also be performed of all safety data through the Day 28 visit for subjects participating in Part 1.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
501
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Vallejo, California, United States, 94589
- Solano Clinical Research
-
-
Florida
-
Miami, Florida, United States, 33143
- Miami Research Associates
-
-
Kansas
-
Kansas City, Kansas, United States, 66211
- Quintiles Phase One Services
-
-
Utah
-
Salt Lake City, Utah, United States, 84124
- Jean Brown Research
-
-
Washington
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Tacoma, Washington, United States, 98418
- Northwest Kinetics
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adult males or females 18-49 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 each vaccination with understanding (through Informed Consent process) to not become pregnant and 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:
- Laboratory abnormalities [as determined by the Toxicity Grading Scale (grade 1 4)] at laboratory 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 first 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 first vaccination
- Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd
- Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™)
- History of travelers' diarrhea in the last two years
- 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 illness
- Previous vaccination with a pandemic candidate 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 first vaccination
- Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to first vaccination
- Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, 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(s)
- Active skin allergy
- Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation
- Hirsute (significant amount of hair) at vaccination area(s)
- Artificial tanning (UV radiation) over the duration of the study including the screening period
- Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s)
- Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination
- Suspicion of or recent history of (within one year of planned vaccination) 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 Guillain Barré syndrome) in the six weeks following a previous influenza vaccination
- Medical history of achlorhydria
- Employee of the investigational site
- History of employment in bird or poultry industries or considerable exposure to birds (e.g. poultry or bird veterinarians, bird breeders, poultry butchers and/or cullers, etc.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 2
|
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
|
|
Experimental: Group 1
|
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
|
|
Experimental: Group 3
|
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
|
|
Experimental: Group 4
|
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
|
|
Experimental: Group 5
|
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
|
|
Experimental: Group 6
|
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
|
|
Experimental: Group 7
|
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
|
|
Experimental: Group 8
|
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
|
|
Experimental: Group 9
|
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
|
|
Placebo Comparator: Group 10
|
Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety of Intramuscular A/H5N1 with and without the LT adjuvant patch
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Demonstration of adjuvant effect and evaluation of immunogenicity
Time Frame: Day 42
|
Day 42
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip Leese, MD, Quintiles Phase One Services
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
September 19, 2007
First Submitted That Met QC Criteria
September 19, 2007
First Posted (Estimate)
September 20, 2007
Study Record Updates
Last Update Posted (Estimate)
March 14, 2012
Last Update Submitted That Met QC Criteria
March 13, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLA101
- HHSSO100200700031C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.