Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

March 13, 2012 updated by: Intercell USA, Inc.

A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System

The purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine System to actively immunize against Enterotoxigenic Escherichia coli disease in a field setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2036

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Berliner Centrum Reise & Tropenmedizin
      • Hamburg, Germany, 20359
        • University Medical Centre Hamburg-Eppendorf
      • Munchen, Germany, 80802
        • Ludwig-Maximilians-Universitat Abt. for Infektions and Tropenmedizin
      • Potsdam, Germany, 14467
        • Klinik for Gastroenterologie & Infektiologie
  • Guatemala
      • Antigua, Guatemala, 03001
        • Trek Study Antigua
      • Guatemala, Guatemala, 01015
        • Isthmian Medical Research Guatemala S.A.
      • Solola, Guatemala, 07001
        • SAMI-SSAPFORFAM Consultorio Privado
    • Quezaltenango CP
      • Quetzaltenango, Quezaltenango CP, Guatemala, 09001
        • Consultorio Privado
  • Mexico
    • Guanajuato
      • San Miguel de Allende, Guanajuato, Mexico, 37700
        • Roberto Maxwell's Office
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Consultorio Privado Torre Medica San Javier
    • Mexico D.F.
      • Mexico City, Mexico D.F., Mexico, 06700
        • Mexican Institute of Clinical Research (IMIC)
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62250
        • Internal Medicine Trek Study Cuernavaca
    • Oaxaca
      • Oaxaca de Juarez, Oaxaca, Mexico, 68000
        • Hospital Reforma
  • United Kingdom
      • London, United Kingdom, WC1E 6JB
        • Hospital for Tropical Diseases
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG2 0TG
        • Synexus Thames Valley Clinical Research Center
    • Birmingham
      • Edgbaston, Birmingham, United Kingdom, B15 2SQ
        • Synexus Midlands Clinical Research Center
    • Lancashire
      • Chorley, Lancashire, United Kingdom, PR7 7NA
        • Synexus Lancashire Clinical Research Center
    • London
      • London Bridge, London, United Kingdom, SE1 1YR
        • Guy's Drug Research Unit
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT2 7 BA
        • Bio-Kinetic Europe Ltd
    • Scottland
      • Glasgow, Scottland, United Kingdom, G81 2DR
        • Synexus Scotland Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-64 years of age at date of first vaccination
  • Good health as determined by medical history and physical inspection
  • Females of child-bearing potential must have a negative pregnancy test prior to first vaccination in teh Country of Origin; females of child-bearing potential must agree not to become pregnant throughout the duration of the study
  • Subjects must have planned travel to an area within 3 hours traveling distance of Mexico City, Cuernavaca, Guadalajara, Oaxaca, or San Miguel de Allende, Mexico or Antigua, Quezaltenango, Guatemala City, or Solola, Guatemala for a minimum duration of stay 7 days (no maximum stay is specified for inclusion).
  • Subject must be able to communicate in English

Exclusion Criteria:

  • Abnormalities as determined by the Investigator/clinician during physical inspection
  • Participated in research involving investigational product within 30 days before planned date of first vaccination
  • Ever received LT, ETEC, or cholera vaccine
  • History of diarrhea while traveling to a developing country within the last year
  • Women who are pregnant or breastfeeding
  • Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease
  • History of Irritable Bowel Syndrome
  • Seizure disorder within the last year
  • Current use of immunosuppressive therapy (excluding inhaled steroids) or current immunodeficiency
  • Known or suspected alcohol abuse or illicit drug use within the last year
  • Medical history of HIV, HBV, or HCV
  • An employee of a study site
  • Known allergies to any component of the vaccine, including adhesives
  • Planned use of antibiotics with known activity against gram negative facultative anaerobes
  • Planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar during the surveillance phase of the study
  • An employee of Intercell (global) or an immediate family member

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
900 subjects will receive a two vaccination regimen with an LT patch
Biological: TD Vaccine System
heat labile enterotoxin of E. coli (LT)
Biological: TD Vaccine System
placebo
PLACEBO_COMPARATOR: 2
900 subjects will receive a two vaccination regimen with a placebo patch
Biological: TD Vaccine System
heat labile enterotoxin of E. coli (LT)
Biological: TD Vaccine System
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of cases with vaccine preventable outcome
Time Frame: Day 17 (17 days after arrival in destination country)
Day 17 (17 days after arrival in destination country)

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of moderate/severe diarrhea
Time Frame: Day 17 (17 days after arrival in destination country)
Day 17 (17 days after arrival in destination country)
Total unformed stool frequency from diarrheal episodes
Time Frame: Day 17 (17 days after arrival in destination country)
Day 17 (17 days after arrival in destination country)
Total duration of diarrheal episodes
Time Frame: Day 17 (17 days after arrival in destination country)
Day 17 (17 days after arrival in destination country)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intercell USA, Inc.

Investigators

  • Principal Investigator: Herbert L Dupont, MD, Center for Infectious Diseases, The University of Texas Health Sciences Center at Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

April 1, 2011

Study Registration Dates

First Submitted

October 8, 2009

First Submitted That Met QC Criteria

October 9, 2009

First Posted (ESTIMATE)

October 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELT301
  • EudraCT Number: 2008-008726-75

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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