A/H5N1/LT Dose Ranging Study

Completed · Phase 2

Conditions studied: Pandemic Influenza

In brief

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).

Key facts

Study ID

NCT00908687

Run by

Intercell USA, Inc.

People needed

500

Starts

2009-05-01

Expected to finish

2011-07-01

Last updated by the study team

2021-12-10

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.