Prevention, Randomized, Double-Blinded, Placebo-Controlled, Parallel Assignment, Safety/Efficacy Study
United States406 participantsStarted 2006-10
Plain-language summary
The main purpose of this study is to evaluate the body's immune response to the LT patch at different doses.
The secondary purpose of this study is to evaluate the safety of the LT patches at different doses and the safety of the skin preparation system. Another secondary purpose is to compare the safety and the body's immune response to LT patches placed on the upper arm versus the lower back.
Who can participate
Age range18 Years – 40 Years
SexALL
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Subjects must meet all of the following criteria to be eligible to participate in the study:
Inclusion Criteria:
* Healthy adult males or females 18 to 40 years of age with 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 prior to each 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, diaphragm with spermicide), and IUD.
Subjects meeting any of the following criteria are not eligible for participation in the study:
Exclusion Criteria:
* Laboratory abnormalities.
* Abnormalities at physical examination
* Known allergies to any component of the vaccine.
* Known disturbance of coagulation.
* Known allergies to adhesives.
* Participated in unrelated 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.
* Ever received cholera toxin or vaccine (e.g. Orocholâ„¢, Dukoralâ„¢).
* Medical history of acute or chronic skin disease at vaccination site(s).
* Active skin allergy.
* Recent or regular use of ora…
What they're measuring
1
To evaluate the immunogenicity of LT application at different doses