CompletedPhase 2

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 range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. Orochol™, Dukoral™). * Medical history of acute or chronic skin disease at vaccination site(s). * Active skin allergy. * Recent or regular use of ora…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the immunogenicity of LT application at different doses

Timeframe: 6 months

Trial details

NCT IDNCT00672035

SponsorIntercell USA, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-12

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