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Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

Primary Purpose

Travelers' Diarrhea

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TD Vaccine System
TD Vaccine System
Sponsored by
Intercell USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Travelers' Diarrhea focused on measuring Prevention of Travelers' Diarrhea

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Berliner Centrum Reise & Tropenmedizin
  • University Medical Centre Hamburg-Eppendorf
  • Ludwig-Maximilians-Universitat Abt. for Infektions and Tropenmedizin
  • Klinik for Gastroenterologie & Infektiologie
  • Consultorio Privado
  • Trek Study Antigua
  • Isthmian Medical Research Guatemala S.A.
  • SAMI-SSAPFORFAM Consultorio Privado
  • Roberto Maxwell's Office
  • Consultorio Privado Torre Medica San Javier
  • Mexican Institute of Clinical Research (IMIC)
  • Internal Medicine Trek Study Cuernavaca
  • Hospital Reforma
  • Synexus Thames Valley Clinical Research Center
  • Synexus Midlands Clinical Research Center
  • Synexus Lancashire Clinical Research Center
  • Guy's Drug Research Unit
  • Bio-Kinetic Europe Ltd
  • Synexus Scotland Clinical Research Center
  • Hospital for Tropical Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of cases with vaccine preventable outcome

Secondary Outcome Measures

The incidence of moderate/severe diarrhea
Total unformed stool frequency from diarrheal episodes
Total duration of diarrheal episodes

Full Information

First Posted
October 8, 2009
Last Updated
March 13, 2012
Sponsor
Intercell USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00993681
Brief Title
Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study
Official Title
A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intercell USA, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Travelers' Diarrhea
Keywords
Prevention of Travelers' Diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2036 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
900 subjects will receive a two vaccination regimen with an LT patch
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
900 subjects will receive a two vaccination regimen with a placebo patch
Intervention Type
Biological
Intervention Name(s)
TD Vaccine System
Intervention Description
heat labile enterotoxin of E. coli (LT)
Intervention Type
Biological
Intervention Name(s)
TD Vaccine System
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Incidence of cases with vaccine preventable outcome
Time Frame
Day 17 (17 days after arrival in destination country)
Secondary Outcome Measure Information:
Title
The incidence of moderate/severe diarrhea
Time Frame
Day 17 (17 days after arrival in destination country)
Title
Total unformed stool frequency from diarrheal episodes
Time Frame
Day 17 (17 days after arrival in destination country)
Title
Total duration of diarrheal episodes
Time Frame
Day 17 (17 days after arrival in destination country)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert L Dupont, MD
Organizational Affiliation
Center for Infectious Diseases, The University of Texas Health Sciences Center at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Berliner Centrum Reise & Tropenmedizin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
University Medical Centre Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20359
Country
Germany
Facility Name
Ludwig-Maximilians-Universitat Abt. for Infektions and Tropenmedizin
City
Munchen
ZIP/Postal Code
80802
Country
Germany
Facility Name
Klinik for Gastroenterologie & Infektiologie
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Consultorio Privado
City
Quetzaltenango
State/Province
Quezaltenango CP
ZIP/Postal Code
09001
Country
Guatemala
Facility Name
Trek Study Antigua
City
Antigua
ZIP/Postal Code
03001
Country
Guatemala
Facility Name
Isthmian Medical Research Guatemala S.A.
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
SAMI-SSAPFORFAM Consultorio Privado
City
Solola
ZIP/Postal Code
07001
Country
Guatemala
Facility Name
Roberto Maxwell's Office
City
San Miguel de Allende
State/Province
Guanajuato
ZIP/Postal Code
37700
Country
Mexico
Facility Name
Consultorio Privado Torre Medica San Javier
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Mexican Institute of Clinical Research (IMIC)
City
Mexico City
State/Province
Mexico D.F.
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Internal Medicine Trek Study Cuernavaca
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62250
Country
Mexico
Facility Name
Hospital Reforma
City
Oaxaca de Juarez
State/Province
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Synexus Thames Valley Clinical Research Center
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
Facility Name
Synexus Midlands Clinical Research Center
City
Edgbaston
State/Province
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Synexus Lancashire Clinical Research Center
City
Chorley
State/Province
Lancashire
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Guy's Drug Research Unit
City
London Bridge
State/Province
London
ZIP/Postal Code
SE1 1YR
Country
United Kingdom
Facility Name
Bio-Kinetic Europe Ltd
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT2 7 BA
Country
United Kingdom
Facility Name
Synexus Scotland Clinical Research Center
City
Glasgow
State/Province
Scottland
ZIP/Postal Code
G81 2DR
Country
United Kingdom
Facility Name
Hospital for Tropical Diseases
City
London
ZIP/Postal Code
WC1E 6JB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24291168
Citation
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.
Results Reference
derived

Learn more about this trial

Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

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