Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch
Completed · Phase 2 · Has a placebo group
Conditions studied: Diarrhea
In brief
The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing
Key facts
- Study ID
- NCT01067781
- Run by
- Intercell USA, Inc.
- People needed
- 600
- Starts
- 2010-02-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2020-02-10
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- A female or male 18-64 (inclusive) years of age;
- In good health as determined by medical history and screening exam;
- Females who are post-menopausal, surgically sterile, or have a negative serum/urine pregnancy test at Day 0 and agree not to become pregnant for the duration of study.
You may not qualify if…
- Abnormalities at physical exam [as determined by the Toxicity Grading Scale (Grade 1-4)];
- Laboratory abnormalities [as determined by the Toxicity Grading Scale (Grade 1 4)] at screening;
- Participated in research involving investigational product within 30 days before planned date of first vaccination;
- Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd;
- Women who are pregnant or breastfeeding;
- Clinically significant underlying enteric, pulmonary, cardiac or renal disease;
- Current seizure disorder;
- Current use of immunosuppressive therapy (inhaled steroids are allowed);
- Known or suspected alcohol abuse or illicit drug use within the last year;
- Positive Serology for HIV-1, HIV-2, HbsAg, or HCV;
- Known allergies to any component of the vaccine including adhesives;
- An employee of the study site;
- An employee of Intercell (global) or an immediate family member;
- Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites;
- Receipt of any routine vaccinations within 7 days prior to, or following, the date of planned study vaccinations.
Where it is running
- Advanced Clinical Research Institute — Anaheim, California, United States
- Miami Research Associates — South Miami, Florida, United States
- Johnson County Clinical Trials — Lenexa, Kansas, United States
- Radiant Research — Cincinnati, Ohio, United States
- Clinical Trials of Texas — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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