Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT00993681
First received: October 8, 2009
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Travelers' Diarrhea
Biological: TD Vaccine System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System

Resource links provided by NLM:


Further study details as provided by Intercell USA, Inc.:

Primary Outcome Measures:
  • Incidence of cases with vaccine preventable outcome [ Time Frame: Day 17 (17 days after arrival in destination country) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of moderate/severe diarrhea [ Time Frame: Day 17 (17 days after arrival in destination country) ] [ Designated as safety issue: No ]
  • Total unformed stool frequency from diarrheal episodes [ Time Frame: Day 17 (17 days after arrival in destination country) ] [ Designated as safety issue: No ]
  • Total duration of diarrheal episodes [ Time Frame: Day 17 (17 days after arrival in destination country) ] [ Designated as safety issue: No ]

Enrollment: 2036
Study Start Date: October 2009
Study Completion Date: April 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Placebo Comparator: 2
900 subjects will receive a two vaccination regimen with a placebo patch
Biological: TD Vaccine System
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993681

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

No publications provided

Responsible Party: Intercell USA, Inc.
ClinicalTrials.gov Identifier: NCT00993681     History of Changes
Other Study ID Numbers: ELT301, EudraCT Number: 2008-008726-75
Study First Received: October 8, 2009
Last Updated: March 13, 2012
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Ethics Commission
Germany: Paul-Ehrlich-Institut
Mexico: Ethics Committee
Mexico: Ministry of Health
Guatemala: Ethics Committee
Guatemala: Ministry of Health

Keywords provided by Intercell USA, Inc.:
Prevention of Travelers' Diarrhea

Additional relevant MeSH terms:
Diarrhea
Dysentery
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 24, 2014