Clinical trial NCT00516659: ETEC Logistics Trial (TREK)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diarrhea
Keywords: ETEC
Traveler's diarrhea
TCI
patch vaccine
diarrhea prevention
epidemiology ETEC
Escherichia coli
Lead sponsor: Intercell USA, Inc.
Sponsor class: INDUSTRY
First posted: 2007-08-15
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

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 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.

Primary outcomes:
measure: 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
timeFrame: during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.
measure: Safety of heat-labile enterotoxin of Escherichia coli (LT) delivered by transcutaneous immunization (TCI) vs placebo
timeFrame: From vaccination 1 to completion of Day 180 follow-up, about a seven month time period
Secondary outcomes:
measure: Stool frequency per episode of ETEC illness in placebo recipients
timeFrame: Duration of stay in Mexico or Guatemala assessed up to four weeks
measure: Immunogenicity of LT delivered by TCI
timeFrame: at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival
measure: Incidence of irritable bowel syndrome following travel to areas of ETEC endemnicity.
timeFrame: Baseline through six months post return from Latin America. A period of about six months.
measure: Incidence of vaccine preventable outcome in placebo and LT patch recipients.
timeFrame: Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: West Coast Clinical Trials
state: California
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University, Bloomberg School of Public Health
state: Maryland
city: Minneapolis
country: United States
facility: Twin Cities Clinical Research
state: Minnesota
city: Hackensack
country: United States
facility: Advanced Biomedical Research
state: New Jersey
city: Ithica
country: United States
facility: Asthma Allergy & Associates
state: New York
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Dallas
country: United States
facility: Radiant Research
state: Texas
city: Houston
country: United States
facility: Breco Research
state: Texas
city: Houston
country: United States
facility: Center for Infectious Diseases, The University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: Radiant Research
state: Texas
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: Tacoma
country: United States
facility: Northwest Kinetics
state: Washington
city: Antigua Guatemala
country: Guatemala
facility: Private Clinic Antigua
city: San Miguel de Allende
country: Mexico
facility: Private Clinic San Miguel
state: Guanajuata
city: Guadalajara
country: Mexico
facility: Private Clinic Guadalajara
state: Jalisco
city: Puerto Vallarta
country: Mexico
facility: AmeriMed Hospital
state: Marina Vallarta
city: Cuernavaca
country: Mexico
facility: Private Clinic Cuernavaca
state: Morelos
city: Cancun
country: Mexico
facility: Hospital Americano
state: Quintana Roo
Study officials:
affiliation: Center for Infectious Diseases, The University of Texas Health Science Center at Houston
name: Herbert L. DuPont, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University, Bloomberg School of Public Health
name: Robin McKenzie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Breco Research, Houston, TX
name: Rama Yerramsetti
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research, San Antonio, TX
name: William P Jennings
role: PRINCIPAL_INVESTIGATOR
affiliation: West Coast Clinical Trials, Long Beach, CA
name: Yu-Luen Hsu
role: PRINCIPAL_INVESTIGATOR
affiliation: Asthma & Allergy Associates, Ithaca, NY
name: Christopher A Smith
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced Biomedical Research, Hackensack, NJ
name: Benno G Roesch
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research, Chicago, IL
name: Jeffrey G Geohas
role: PRINCIPAL_INVESTIGATOR
affiliation: Jean Brown Research, Salt Lake City, UT
name: Gilbert Podolsky
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwest Kinetics, Tacoma, WA
name: Thomas Lagen
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research, Dallas, TX
name: Roy M Fleischmann
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research, Columbus, OH
name: Douglas R Schumacher
role: PRINCIPAL_INVESTIGATOR
affiliation: Twin Cities Clinical Research, Minneapolis, MN
name: Norman M Lunde
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Autonoma De Guadalajara, Mexico
name: Francisco G Sandoval
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Autonoma Guadalajara, Mexico
name: Juan Hector M Romero
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas, Cuernavaca, Mexico
name: Jaime B Gerson
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad del Valle de Guatemala (Antigua)
name: Edwin Asturias
role: PRINCIPAL_INVESTIGATOR
affiliation: AmeriMed Puerto Vallarta, Mexico
name: Roberto Garcia
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Americano, Cancun, Mexico
name: Martha V Serrato
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Clinic, San Miguel de Allende, Mexico
name: Robert Maxwell
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.