ETEC Logistics Trial (TREK)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diarrhea

Intervention / Treatment
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* Biological: Heat-Labile Enterotoxin of Escherichia coli (LT)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>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)<br>* Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.<br>|
| Placebo Comparator: Group 2<br>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<br>* The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TCI, ETEC, Traveler's diarrhea, patch vaccine, diarrhea prevention, epidemiology ETEC, Escherichia coli