ETEC Logistics Trial (TREK)

NCT00516659 | Completed Phase 2 DMC

• 1 other identifier: ELT206
• Study Type: interventional
• Target: 201
• Locations: 3 countries
• Sites: 19

Brief 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

Keywords

ETEC; Traveler's diarrhea; TCI; patch vaccine; diarrhea prevention; epidemiology ETEC; Escherichia coli

Outcome Measures

Primary Outcomes (2)

• 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

  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

  From vaccination 1 to completion of Day 180 follow-up, about a seven month time period

Secondary Outcomes (4)

• Stool frequency per episode of ETEC illness in placebo recipients

  Duration of stay in Mexico or Guatemala assessed up to four weeks

• Immunogenicity of LT delivered by TCI

  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.

  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.

  Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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)

Group 2

PLACEBO COMPARATOR

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

Interventions

Heat-Labile Enterotoxin of Escherichia coli (LT) BIOLOGICAL

Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.

Group 1

Placebo BIOLOGICAL

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

Group 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Intercell USA, Inc.: lead

Study Sites (19)

West Coast Clinical Trials

Long Beach, California, 90806, United States

Location

Radiant Research

Chicago, Illinois, 60610, United States

Location

Johns Hopkins University, Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Twin Cities Clinical Research

Minneapolis, Minnesota, 55430, United States

Location

Advanced Biomedical Research

Hackensack, New Jersey, 07601, United States

Location

Asthma Allergy & Associates

Ithica, New York, 14850, United States

Location

Radiant Research

Columbus, Ohio, 43212, United States

Location

Radiant Research

Dallas, Texas, 75235, United States

Location

Breco Research

Houston, Texas, 77024, United States

Location

Center for Infectious Diseases, The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Radiant Research

San Antonio, Texas, 78229, United States

Location

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Northwest Kinetics

Tacoma, Washington, 98418, United States

Location

Private Clinic Antigua

Antigua Guatemala, 03001, Guatemala

Location

Private Clinic San Miguel

San Miguel de Allende, Guanajuata, 37700, Mexico

Location

Private Clinic Guadalajara

Guadalajara, Jalisco, 44690, Mexico

Location

AmeriMed Hospital

Puerto Vallarta, Marina Vallarta, 48334, Mexico

Location

Private Clinic Cuernavaca

Cuernavaca, Morelos, 62250, Mexico

Location

Hospital Americano

Cancún, Quintana Roo, 77500, Mexico

Location

Related Publications (1)

• 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.

  PMID: 18554712 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Diarrhea; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2007
• First Posted: August 15, 2007
• Study Start: May 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 14, 2012

Record last verified: 2012-03

Locations

GU (1); ME (5); US (13)