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
PHASE2
201 participants
INTERVENTIONAL
2006-05-31
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Challenge Study of an ETEC Vaccine
NCT01922856
Phase 1 Study of dmLT ID Vaccination in Healthy Adults
NCT02531685
A Double-Blind Placebo-Control Dose Escalating Study to Evaluate the Safety and Immunogenicity of dmLT by Oral, Sublingual and Intradermal Vaccination in Adults Residing in an Endemic Area
NCT03548064
LT Vaccine Patch Self-Administration Study
NCT00565461
Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study
NCT00993681
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
evaluate the stool frequency per episode of ETEC illness in placebo recipients, to evaluate the immunogenicity of LT delivered by TCI, to evaluate the incidence of IBS following travel to areas of ETEC endemnicity, and to evaluate the incidence of VPO in placebo and LT patch recipients.
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
FACTORIAL
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Group 1 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 37.5µg LT
Heat-Labile Enterotoxin of Escherichia coli (LT)
Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.
Group 2
Group 2 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 0µg LT (placebo patch containing no LT)
Placebo
The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Heat-Labile Enterotoxin of Escherichia coli (LT)
Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.
Placebo
The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Signed Informed Consent form
* Planned travel to an area within 2 ½ hours traveling distance of Cuernavaca or Guadalajara, Mexico or Antigua, Guatemala (minimum stay of 7 days)
* If female who is not post-menopausal or surgically sterile, negative pregnancy test (within 24 hours prior to vaccination) and agreement to employ an effective form of birth control or practice abstinence through the end of the study.
Exclusion Criteria
* Received investigational product from 30 days before date of first vaccination or during the entire study period
* Ever received LT, ETEC, or cholera vaccine
* History of traveler's diarrhea within the previous year
* Travel to a developing country within the last year
* Women who are pregnant or breastfeeding
* History of achlorhydria
* Evidence of immunosuppression, including concomitant immunosuppressive therapy; fever \> 99.5°F (37.5°C) on day of vaccination
* Current problems with alcohol or substance abuse
* An employee of the study clinic
* Sensitivity or allergy to any of the vaccine components
* History of significant blood loss, blood product donation, or blood product recipient in the previous 60 days
* Planned use of Imodium or antibiotics for self treatment of diarrhea during the study period
* Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites; and
* Medical history of acute or chronic GI illness or major GI surgery.
18 Years
64 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
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.
Herbert L. DuPont, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Infectious Diseases, The University of Texas Health Science Center at Houston
Robin McKenzie, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University, Bloomberg School of Public Health
Rama Yerramsetti
Role: PRINCIPAL_INVESTIGATOR
Breco Research, Houston, TX
William P Jennings
Role: PRINCIPAL_INVESTIGATOR
Radiant Research, San Antonio, TX
Yu-Luen Hsu
Role: PRINCIPAL_INVESTIGATOR
West Coast Clinical Trials, Long Beach, CA
Christopher A Smith
Role: PRINCIPAL_INVESTIGATOR
Asthma & Allergy Associates, Ithaca, NY
Benno G Roesch
Role: PRINCIPAL_INVESTIGATOR
Advanced Biomedical Research, Hackensack, NJ
Jeffrey G Geohas
Role: PRINCIPAL_INVESTIGATOR
Radiant Research, Chicago, IL
Gilbert Podolsky
Role: PRINCIPAL_INVESTIGATOR
Jean Brown Research, Salt Lake City, UT
Thomas Lagen
Role: PRINCIPAL_INVESTIGATOR
Northwest Kinetics, Tacoma, WA
Roy M Fleischmann
Role: PRINCIPAL_INVESTIGATOR
Radiant Research, Dallas, TX
Douglas R Schumacher
Role: PRINCIPAL_INVESTIGATOR
Radiant Research, Columbus, OH
Norman M Lunde
Role: PRINCIPAL_INVESTIGATOR
Twin Cities Clinical Research, Minneapolis, MN
Francisco G Sandoval
Role: PRINCIPAL_INVESTIGATOR
Universidad Autonoma De Guadalajara, Mexico
Juan Hector M Romero
Role: PRINCIPAL_INVESTIGATOR
Universidad Autonoma Guadalajara, Mexico
Jaime B Gerson
Role: PRINCIPAL_INVESTIGATOR
University of Texas, Cuernavaca, Mexico
Edwin Asturias
Role: PRINCIPAL_INVESTIGATOR
Universidad del Valle de Guatemala (Antigua)
Roberto Garcia
Role: PRINCIPAL_INVESTIGATOR
AmeriMed Puerto Vallarta, Mexico
Martha V Serrato
Role: PRINCIPAL_INVESTIGATOR
Hospital Americano, Cancun, Mexico
Robert Maxwell
Role: PRINCIPAL_INVESTIGATOR
Private Clinic, San Miguel de Allende, Mexico
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
West Coast Clinical Trials
Long Beach, California, United States
Radiant Research
Chicago, Illinois, United States
Johns Hopkins University, Bloomberg School of Public Health
Baltimore, Maryland, United States
Twin Cities Clinical Research
Minneapolis, Minnesota, United States
Advanced Biomedical Research
Hackensack, New Jersey, United States
Asthma Allergy & Associates
Ithica, New York, United States
Radiant Research
Columbus, Ohio, United States
Radiant Research
Dallas, Texas, United States
Breco Research
Houston, Texas, United States
Center for Infectious Diseases, The University of Texas Health Science Center at Houston
Houston, Texas, United States
Radiant Research
San Antonio, Texas, United States
Jean Brown Research
Salt Lake City, Utah, United States
Northwest Kinetics
Tacoma, Washington, United States
Private Clinic Antigua
Antigua Guatemala, , Guatemala
Private Clinic San Miguel
San Miguel de Allende, Guanajuata, Mexico
Private Clinic Guadalajara
Guadalajara, Jalisco, Mexico
AmeriMed Hospital
Puerto Vallarta, Marina Vallarta, Mexico
Private Clinic Cuernavaca
Cuernavaca, Morelos, Mexico
Hospital Americano
Cancún, Quintana Roo, Mexico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Frech SA, Dupont HL, Bourgeois AL, McKenzie R, Belkind-Gerson J, Figueroa JF, Okhuysen PC, Guerrero NH, Martinez-Sandoval FG, Melendez-Romero JH, Jiang ZD, Asturias EJ, Halpern J, Torres OR, Hoffman AS, Villar CP, Kassem RN, Flyer DC, Andersen BH, Kazempour K, Breisch SA, Glenn GM. Use of a patch containing heat-labile toxin from Escherichia coli against travellers' diarrhoea: a phase II, randomised, double-blind, placebo-controlled field trial. Lancet. 2008 Jun 14;371(9629):2019-25. doi: 10.1016/S0140-6736(08)60839-9.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ELT206
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.