ETEC Logistics Trial (TREK)

Diarrhea Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516659
• Other study ID #: ELT206
• Status: Completed
• Phase: Phase 2
• First received: August 13, 2007
• Last updated: March 13, 2012
• Start date: May 2006
• Est. completion date: December 2007

Study information

• Verified date: March 2012
• Source: Intercell USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationMexico: Ministry of HealthGuatemala: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diarrhea

Intervention

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

Locations

Country	Name	City	State
Guatemala	Private Clinic Antigua	Antigua Guatemala
Mexico	Hospital Americano	Cancun	Quintana Roo
Mexico	Private Clinic Cuernavaca	Cuernavaca	Morelos
Mexico	Private Clinic Guadalajara	Guadalajara	Jalisco
Mexico	AmeriMed Hospital	Puerto Vallarta	Marina Vallarta
Mexico	Private Clinic San Miguel	San Miguel de Allende	Guanajuata
United States	Johns Hopkins University, Bloomberg School of Public Health	Baltimore	Maryland
United States	Radiant Research	Chicago	Illinois
United States	Radiant Research	Columbus	Ohio
United States	Radiant Research	Dallas	Texas
United States	Advanced Biomedical Research	Hackensack	New Jersey
United States	Breco Research	Houston	Texas
United States	Center for Infectious Diseases, The University of Texas Health Science Center at Houston	Houston	Texas
United States	Asthma Allergy & Associates	Ithica	New York
United States	West Coast Clinical Trials	Long Beach	California
United States	Twin Cities Clinical Research	Minneapolis	Minnesota
United States	Jean Brown Research	Salt Lake City	Utah
United States	Radiant Research	San Antonio	Texas
United States	Northwest Kinetics	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Intercell USA, Inc.

Countries where clinical trial is conducted

United States,  Guatemala,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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	Yes
Secondary	Stool frequency per episode of ETEC illness in placebo recipients		Duration of stay in Mexico or Guatemala assessed up to four weeks	No
Secondary	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	No
Secondary	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.	No
Secondary	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.	No