Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

Phase 3

Completed

• Conditions: Travelers' Diarrhea
• Interventions: Biological: TD Vaccine System

• Registration Number: NCT00993681
• Lead Sponsor: Intercell USA, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-10-09
• Study First Posted: 2009-10-12
• Primary Completion: 2010-11
• Study Completion: 2011-04
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2036

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	TD Vaccine System	900 subjects will receive a two vaccination regimen with an LT patch
2	TD Vaccine System	900 subjects will receive a two vaccination regimen with a placebo patch

Primary Outcome Measures

Name	Time	Method
Incidence of cases with vaccine preventable outcome	Day 17 (17 days after arrival in destination country)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (20)

Synexus Midlands Clinical Research Center; 🇬🇧 Edgbaston, Birmingham, United Kingdom

Roberto Maxwell's Office; 🇲🇽 San Miguel de Allende, Guanajuato, Mexico

Berliner Centrum Reise & Tropenmedizin; 🇩🇪 Berlin, Germany

Ludwig-Maximilians-Universitat Abt. for Infektions and Tropenmedizin; 🇩🇪 Munchen, Germany

Klinik for Gastroenterologie & Infektiologie; 🇩🇪 Potsdam, Germany

University Medical Centre Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Trek Study Antigua; 🇬🇹 Antigua, Guatemala

Isthmian Medical Research Guatemala S.A.; 🇬🇹 Guatemala, Guatemala

SAMI-SSAPFORFAM Consultorio Privado; 🇬🇹 Solola, Guatemala

Consultorio Privado; 🇬🇹 Quetzaltenango, Quezaltenango CP, Guatemala

Mexican Institute of Clinical Research (IMIC); 🇲🇽 Mexico City, Mexico D.F., Mexico

Internal Medicine Trek Study Cuernavaca; 🇲🇽 Cuernavaca, Morelos, Mexico

Consultorio Privado Torre Medica San Javier; 🇲🇽 Guadalajara, Jalisco, Mexico

Hospital Reforma; 🇲🇽 Oaxaca de Juarez, Oaxaca, Mexico

Synexus Thames Valley Clinical Research Center; 🇬🇧 Reading, Berkshire, United Kingdom

Synexus Lancashire Clinical Research Center; 🇬🇧 Chorley, Lancashire, United Kingdom

Bio-Kinetic Europe Ltd; 🇬🇧 Belfast, Northern Ireland, United Kingdom

Guy's Drug Research Unit; 🇬🇧 London Bridge, London, United Kingdom

Synexus Scotland Clinical Research Center; 🇬🇧 Glasgow, Scottland, United Kingdom

Hospital for Tropical Diseases; 🇬🇧 London, United Kingdom