ETEC Logistics Trial (TREK) - Full Text View

Sponsor:	Intercell USA, Inc.
Information provided by:	Intercell USA, Inc.
ClinicalTrials.gov Identifier:	NCT00516659

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 II

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diarrhea

U.S. FDA Resources

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

Show 19 Study Locations

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Intercell USA, Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Frech SA, Dupont HL, Bourgeois AL, McKenzie R, Belkind-Gerson J, Figueroa JF, Okhuysen PC, Guerrero NH, Martinez-Sandoval FG, Meléndez-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.

Responsible Party:	Iomai Corp. ( Dr. Sarah Frech )
Study ID Numbers:	ELT206
Study First Received:	August 13, 2007
Last Updated:	January 4, 2008
ClinicalTrials.gov Identifier:	NCT00516659 History of Changes
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:

Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 27, 2009