NCT00516659

ETEC Logistics Trial (TREK)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Intercell USA, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diarrhea

Interventions

Type	Name	Description
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.
BIOLOGICAL	Placebo	The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-01-01
• Completion: 2007-12-01
• First posted: 2007-08-15
• Last updated: 2012-03-14

Locations

19 sites across 3 countries: United States, Guatemala, Mexico