ETEC Logistics Trial (TREK) (Trek)

March 13, 2012 updated by: Intercell USA, Inc.

A Phase II, Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Epidemiology of Natural Infection With Enterotoxigenic Escherichia Coli Occurring After Transcutaneous Immunization in a Field Setting

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objectives of the study are to evaluate the incidence of ETEC illness in a field setting and to compare the safety of LT delivered by TCI with placebo. The secondary objectives include, but are not limited to:

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.

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guatemala
      • Antigua Guatemala, Guatemala, 03001
        • Private Clinic Antigua
  • Mexico
    • Guanajuata
      • San Miguel de Allende, Guanajuata, Mexico, 37700
        • Private Clinic San Miguel
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44690
        • Private Clinic Guadalajara
    • Marina Vallarta
      • Puerto Vallarta, Marina Vallarta, Mexico, 48334
        • AmeriMed Hospital
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Private Clinic Cuernavaca
    • Quintana Roo
      • Cancun, Quintana Roo, Mexico, 77500
        • Hospital Americano
  • United States
    • California
      • Long Beach, California, United States, 90806
        • West Coast Clinical Trials
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Radiant Research
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University, Bloomberg School of Public Health
    • Minnesota
      • Minneapolis, Minnesota, United States, 55430
        • Twin Cities Clinical Research
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Advanced Biomedical Research
    • New York
      • Ithica, New York, United States, 14850
        • Asthma Allergy & Associates
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Radiant Research
    • Texas
      • Dallas, Texas, United States, 75235
        • Radiant Research
      • Houston, Texas, United States, 77024
        • Breco Research
      • Houston, Texas, United States, 77030
        • Center for Infectious Diseases, The University of Texas Health Science Center at Houston
      • San Antonio, Texas, United States, 78229
        • Radiant Research
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research
    • Washington
      • Tacoma, Washington, United States, 98418
        • Northwest Kinetics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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.
Placebo Comparator: 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)
Biological: Placebo
The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Enterotoxigenic Escherichia coli (ETEC) illness defined as a diarrheal episode associated with an LT, LT/ST, or ST-positive ETEC strain isolated from a sample of a stool
Time Frame: during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.
during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.
Safety of heat-labile enterotoxin of Escherichia coli (LT) delivered by transcutaneous immunization (TCI) vs placebo
Time Frame: From vaccination 1 to completion of Day 180 follow-up, about a seven month time period
From vaccination 1 to completion of Day 180 follow-up, about a seven month time period

Secondary Outcome Measures

Outcome Measure
Time Frame
Stool frequency per episode of ETEC illness in placebo recipients
Time Frame: Duration of stay in Mexico or Guatemala assessed up to four weeks
Duration of stay in Mexico or Guatemala assessed up to four weeks
Immunogenicity of LT delivered by TCI
Time Frame: at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival
at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival
Incidence of irritable bowel syndrome following travel to areas of ETEC endemnicity.
Time Frame: Baseline through six months post return from Latin America. A period of about six months.
Baseline through six months post return from Latin America. A period of about six months.
Incidence of vaccine preventable outcome in placebo and LT patch recipients.
Time Frame: Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.
Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intercell USA, Inc.

Investigators

  • Principal Investigator: Herbert L. DuPont, MD, Center for Infectious Diseases, The University of Texas Health Science Center at Houston
  • Principal Investigator: Robin McKenzie, MD, Johns Hopkins University, Bloomberg School of Public Health
  • Principal Investigator: Rama Yerramsetti, Breco Research, Houston, TX
  • Principal Investigator: William P Jennings, Radiant Research, San Antonio, TX
  • Principal Investigator: Yu-Luen Hsu, West Coast Clinical Trials, Long Beach, CA
  • Principal Investigator: Christopher A Smith, Asthma & Allergy Associates, Ithaca, NY
  • Principal Investigator: Benno G Roesch, Advanced Biomedical Research, Hackensack, NJ
  • Principal Investigator: Jeffrey G Geohas, Radiant Research, Chicago, IL
  • Principal Investigator: Gilbert Podolsky, Jean Brown Research, Salt Lake City, UT
  • Principal Investigator: Thomas Lagen, Northwest Kinetics, Tacoma, WA
  • Principal Investigator: Roy M Fleischmann, Radiant Research, Dallas, TX
  • Principal Investigator: Douglas R Schumacher, Radiant Research, Columbus, OH
  • Principal Investigator: Norman M Lunde, Twin Cities Clinical Research, Minneapolis, MN
  • Principal Investigator: Francisco G Sandoval, Universidad Autonoma De Guadalajara, Mexico
  • Principal Investigator: Juan Hector M Romero, Universidad Autonoma Guadalajara, Mexico
  • Principal Investigator: Jaime B Gerson, University of Texas, Cuernavaca, Mexico
  • Principal Investigator: Edwin Asturias, Universidad del Valle de Guatemala (Antigua)
  • Principal Investigator: Roberto Garcia, AmeriMed Puerto Vallarta, Mexico
  • Principal Investigator: Martha V Serrato, Hospital Americano, Cancun, Mexico
  • Principal Investigator: Robert Maxwell, Private Clinic, San Miguel de Allende, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 13, 2007

First Submitted That Met QC Criteria

August 14, 2007

First Posted (Estimate)

August 15, 2007

Study Record Updates

Last Update Posted (Estimate)

March 14, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELT206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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