ETEC Logistics Trial (TREK) (Trek)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT00516659
First received: August 13, 2007
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Diarrhea
Biological: Heat-Labile Enterotoxin of Escherichia coli (LT)
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Intercell USA, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Stool frequency per episode of ETEC illness in placebo recipients [ Time Frame: Duration of stay in Mexico or Guatemala assessed up to four weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 201
Study Start Date: May 2006
Study Completion Date: December 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516659

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

Additional Information:
No publications provided by Intercell USA, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Intercell USA, Inc.
ClinicalTrials.gov Identifier: NCT00516659     History of Changes
Other Study ID Numbers: ELT206
Study First Received: August 13, 2007
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health
Guatemala: Ministry of Health

Keywords provided by Intercell USA, Inc.:
ETEC
Traveler's diarrhea
TCI
patch vaccine
diarrhea prevention
epidemiology ETEC
Escherichia coli

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014