ETEC Logistics Trial (TREK)

Summary

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.

Conditions

• Diarrhea

Interventions

BIOLOGICAL

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.

BIOLOGICAL

Placebo

The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.

Sponsors & Collaborators

• Intercell USA, Inc.

  lead INDUSTRY

Principal Investigators

• Herbert L. DuPont, MD · Center for Infectious Diseases, The University of Texas Health Science Center at Houston

• Robin McKenzie, MD · Johns Hopkins University, Bloomberg School of Public Health

• Rama Yerramsetti · Breco Research, Houston, TX

• William P Jennings · Radiant Research, San Antonio, TX

• Yu-Luen Hsu · West Coast Clinical Trials, Long Beach, CA

• Christopher A Smith · Asthma & Allergy Associates, Ithaca, NY

• Benno G Roesch · Advanced Biomedical Research, Hackensack, NJ

• Jeffrey G Geohas · Radiant Research, Chicago, IL

• Gilbert Podolsky · Jean Brown Research, Salt Lake City, UT

• Thomas Lagen · Northwest Kinetics, Tacoma, WA

• Roy M Fleischmann · Radiant Research, Dallas, TX

• Douglas R Schumacher · Radiant Research, Columbus, OH

• Norman M Lunde · Twin Cities Clinical Research, Minneapolis, MN

• Francisco G Sandoval · Universidad Autonoma De Guadalajara, Mexico

• Juan Hector M Romero · Universidad Autonoma Guadalajara, Mexico

• Jaime B Gerson · University of Texas, Cuernavaca, Mexico

• Edwin Asturias · Universidad del Valle de Guatemala (Antigua)

• Roberto Garcia · AmeriMed Puerto Vallarta, Mexico

• Martha V Serrato · Hospital Americano, Cancun, Mexico

• Robert Maxwell · Private Clinic, San Miguel de Allende, Mexico

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-05-31

Primary Completion

2007-01-31

Completion

2007-12-31

Countries

• United States
• Guatemala
• Mexico

Study Locations