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Completed

NCT Number: NCT00516659

ETEC Logistics Trial (TREK)

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.

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Key information

Conditions

Diarrhea Bacterial Infections Bacterial Infections and Mycoses Enterobacteriaceae Infections Escherichia coli Infections Gram-Negative Bacterial Infections Infections Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Private Clinic Antigua, Antigua Guatemala, Guatemala

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heat-Labile Enterotoxin of Escherichia coli (LT)

Biological

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

Placebo

Biological

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

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Stool frequency per episode of ETEC illness in placebo recipients

    Time frame: Duration of stay in Mexico or Guatemala assessed up to four weeks

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Intercell USA, Inc.

Industry

Registry information

Official study 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

Acronym: Trek

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 15, 2007
Registry last updated
Mar 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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