Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
501 participants
INTERVENTIONAL
2007-08-31
2008-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A/H5N1/LT Dose Ranging Study
NCT00908687
A/H5N1 Virus-Like Particle Antigen Dose Ranging Study With Adjuvant 1
NCT01594320
Phase 1 Study of a H5N1 Influenza Vaccine (Reverse Genetic Reassortant)
NCT00783926
H5N1 Priming and Boosting Strategies
NCT00703053
A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults
NCT06382311
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
A/H5N1
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
Group 2
A/H5N1
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Group 3
A/H5N1
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Group 4
A/H5N1
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Group 5
A/H5N1
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Group 6
A/H5N1
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Group 7
A/H5N1
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Group 8
A/H5N1
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
Group 9
A/H5N1
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Group 10
Placebo
Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
A/H5N1
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21
A/H5N1
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
A/H5N1
Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
A/H5N1
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
A/H5N1
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
A/H5N1
Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
A/H5N1
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
A/H5N1
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21
A/H5N1
High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21
Placebo
Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 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
* 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.)
18 Years
49 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Department of Health and Human Services
FED
Intercell USA, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Philip Leese, MD
Role: PRINCIPAL_INVESTIGATOR
Quintiles Phase One Services
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Solano Clinical Research
Vallejo, California, United States
Miami Research Associates
Miami, Florida, United States
Quintiles Phase One Services
Kansas City, Kansas, United States
Jean Brown Research
Salt Lake City, Utah, United States
Northwest Kinetics
Tacoma, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HHSSO100200700031C
Identifier Type: -
Identifier Source: secondary_id
PLA101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.