Clinical trial NCT00993681: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Travelers' Diarrhea
Keywords: Prevention of Travelers' Diarrhea
Lead sponsor: Intercell USA, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-12
Enrollment: 2036
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of cases with vaccine preventable outcome
timeFrame: Day 17 (17 days after arrival in destination country)
Secondary outcomes:
measure: The incidence of moderate/severe diarrhea
timeFrame: Day 17 (17 days after arrival in destination country)
measure: Total unformed stool frequency from diarrheal episodes
timeFrame: Day 17 (17 days after arrival in destination country)
measure: Total duration of diarrheal episodes
timeFrame: Day 17 (17 days after arrival in destination country)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Berliner Centrum Reise & Tropenmedizin
city: Hamburg
country: Germany
facility: University Medical Centre Hamburg-Eppendorf
city: Munchen
country: Germany
facility: Ludwig-Maximilians-Universitat Abt. for Infektions and Tropenmedizin
city: Potsdam
country: Germany
facility: Klinik for Gastroenterologie & Infektiologie
city: Quetzaltenango
country: Guatemala
facility: Consultorio Privado
state: Quezaltenango CP
city: Antigua
country: Guatemala
facility: Trek Study Antigua
city: Guatemala
country: Guatemala
facility: Isthmian Medical Research Guatemala S.A.
city: Solola
country: Guatemala
facility: SAMI-SSAPFORFAM Consultorio Privado
city: San Miguel de Allende
country: Mexico
facility: Roberto Maxwell's Office
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Consultorio Privado Torre Medica San Javier
state: Jalisco
city: Mexico City
country: Mexico
facility: Mexican Institute of Clinical Research (IMIC)
state: Mexico D.F.
city: Cuernavaca
country: Mexico
facility: Internal Medicine Trek Study Cuernavaca
state: Morelos
city: Oaxaca de Juarez
country: Mexico
facility: Hospital Reforma
state: Oaxaca
city: Reading
country: United Kingdom
facility: Synexus Thames Valley Clinical Research Center
state: Berkshire
city: Edgbaston
country: United Kingdom
facility: Synexus Midlands Clinical Research Center
state: Birmingham
city: Chorley
country: United Kingdom
facility: Synexus Lancashire Clinical Research Center
state: Lancashire
city: London Bridge
country: United Kingdom
facility: Guy's Drug Research Unit
state: London
city: Belfast
country: United Kingdom
facility: Bio-Kinetic Europe Ltd
state: Northern Ireland
city: Glasgow
country: United Kingdom
facility: Synexus Scotland Clinical Research Center
state: Scottland
city: London
country: United Kingdom
facility: Hospital for Tropical Diseases
Study officials:
affiliation: Center for Infectious Diseases, The University of Texas Health Sciences Center at Houston
name: Herbert L Dupont, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.