ETEC Logistics Trial (TREK)

Completed · Phase 2 · Has a placebo group

Conditions studied: Diarrhea

In brief

This is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate the epidemiology of natural infection with ETEC occurring after transcutaneous immunization in a field setting.

Key facts

Study ID

NCT00516659

Run by

Intercell USA, Inc.

People needed

201

Starts

2006-05-01

Expected to finish

2007-12-01

Last updated by the study team

2012-03-14

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult men and women 18-64 years of age inclusive at screening
• 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.

You may not qualify if…

• Clinically significant abnormalities as determined by the Investigator/clinician during physical inspection
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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