NCT00993681

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,036

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2009

Geographic Reach
4 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

March 14, 2012

Status Verified

March 1, 2012

Enrollment Period

1.1 years

First QC Date

October 8, 2009

Last Update Submit

March 13, 2012

Conditions

Travelers' Diarrhea

Keywords

Prevention of Travelers' Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Incidence of cases with vaccine preventable outcome

    Day 17 (17 days after arrival in destination country)

Secondary Outcomes (3)

  • The incidence of moderate/severe diarrhea

    Day 17 (17 days after arrival in destination country)

  • Total unformed stool frequency from diarrheal episodes

    Day 17 (17 days after arrival in destination country)

  • Total duration of diarrheal episodes

    Day 17 (17 days after arrival in destination country)

Study Arms (2)

1

EXPERIMENTAL

900 subjects will receive a two vaccination regimen with an LT patch

Biological: TD Vaccine System

2

PLACEBO COMPARATOR

900 subjects will receive a two vaccination regimen with a placebo patch

Biological: TD Vaccine System

Interventions

TD Vaccine SystemBIOLOGICAL

heat labile enterotoxin of E. coli (LT)

1

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Subject must be able to communicate in English

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

University Medical Centre Hamburg-Eppendorf

Hamburg, Hamburg, 20359, Germany

Location

Ludwig-Maximilians-Universitat Abt. for Infektions and Tropenmedizin

München, Munchen, 80802, Germany

Location

Klinik for Gastroenterologie & Infektiologie

Potsdam, Potsdam, 14467, Germany

Location

Berliner Centrum Reise & Tropenmedizin

Berlin, State of Berlin, 10117, Germany

Location

Trek Study Antigua

Antigua, Departamento de Guatemala, 03001, Guatemala

Location

Isthmian Medical Research Guatemala S.A.

Guatemala City, Departamento de Guatemala, 01015, Guatemala

Location

SAMI-SSAPFORFAM Consultorio Privado

Sololá, Departamento de Sololá, 07001, Guatemala

Location

Consultorio Privado

Quetzaltenango, Quezaltenango CP, 09001, Guatemala

Location

Roberto Maxwell's Office

San Miguel de Allende, Guanajuato, 37700, Mexico

Location

Consultorio Privado Torre Medica San Javier

Guadalajara, Jalisco, 44670, Mexico

Location

Mexican Institute of Clinical Research (IMIC)

Mexico City, Mexico City, 06700, Mexico

Location

Internal Medicine Trek Study Cuernavaca

Cuernavaca, Morelos, 62250, Mexico

Location

Hospital Reforma

Oaxaca City, Oaxaca, 68000, Mexico

Location

Synexus Thames Valley Clinical Research Center

Reading, Berkshire, RG2 0TG, United Kingdom

Location

Synexus Midlands Clinical Research Center

Edgbaston, Birmingham, B15 2SQ, United Kingdom

Location

Synexus Lancashire Clinical Research Center

Chorley, Lancashire, PR7 7NA, United Kingdom

Location

Hospital for Tropical Diseases

London, London, WC1E 6JB, United Kingdom

Location

Guy's Drug Research Unit

London Bridge, London, SE1 1YR, United Kingdom

Location

Bio-Kinetic Europe Ltd

Belfast, Northern Ireland, BT2 7 BA, United Kingdom

Location

Synexus Scotland Clinical Research Center

Glasgow, Scottland, G81 2DR, United Kingdom

Location

Related Publications (1)

  • Behrens RH, Cramer JP, Jelinek T, Shaw H, von Sonnenburg F, Wilbraham D, Weinke T, Bell DJ, Asturias E, Pauwells HL, Maxwell R, Paredes-Paredes M, Glenn GM, Dewasthaly S, Stablein DM, Jiang ZD, DuPont HL. Efficacy and safety of a patch vaccine containing heat-labile toxin from Escherichia coli against travellers' diarrhoea: a phase 3, randomised, double-blind, placebo-controlled field trial in travellers from Europe to Mexico and Guatemala. Lancet Infect Dis. 2014 Mar;14(3):197-204. doi: 10.1016/S1473-3099(13)70297-4. Epub 2013 Nov 29.

    PMID: 24291168DERIVED

Study Officials

  • Herbert L Dupont, MD

    Center for Infectious Diseases, The University of Texas Health Sciences Center at Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 12, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2010

Study Completion

April 1, 2011

Last Updated

March 14, 2012

Record last verified: 2012-03

Locations

ME(5)GU(4)GB(7)DE(4)