Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

Travelers' Diarrhea Clinical Trial

Official title:

A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993681
• Other study ID #: ELT301
• Secondary ID: EudraCT Number:
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2009
• Last updated: March 13, 2012
• Start date: October 2009
• Est. completion date: April 2011

Study information

• Verified date: March 2012
• Source: Intercell USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Ethics CommissionGermany: Paul-Ehrlich-InstitutMexico: Ethics CommitteeMexico: Ministry of HealthGuatemala: Ethics CommitteeGuatemala: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2036
• Est. completion date: April 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• Dysentery
• Travelers' Diarrhea

Intervention

Biological:
• TD Vaccine System
heat labile enterotoxin of E. coli (LT)
• TD Vaccine System
placebo

Locations

Country	Name	City	State
Germany	Berliner Centrum Reise & Tropenmedizin	Berlin
Germany	University Medical Centre Hamburg-Eppendorf	Hamburg
Germany	Ludwig-Maximilians-Universitat Abt. for Infektions and Tropenmedizin	Munchen
Germany	Klinik for Gastroenterologie & Infektiologie	Potsdam
Guatemala	Trek Study Antigua	Antigua
Guatemala	Isthmian Medical Research Guatemala S.A.	Guatemala
Guatemala	Consultorio Privado	Quetzaltenango	Quezaltenango CP
Guatemala	SAMI-SSAPFORFAM Consultorio Privado	Solola
Mexico	Internal Medicine Trek Study Cuernavaca	Cuernavaca	Morelos
Mexico	Consultorio Privado Torre Medica San Javier	Guadalajara	Jalisco
Mexico	Mexican Institute of Clinical Research (IMIC)	Mexico City	Mexico D.F.
Mexico	Hospital Reforma	Oaxaca de Juarez	Oaxaca
Mexico	Roberto Maxwell's Office	San Miguel de Allende	Guanajuato
United Kingdom	Bio-Kinetic Europe Ltd	Belfast	Northern Ireland
United Kingdom	Synexus Lancashire Clinical Research Center	Chorley	Lancashire
United Kingdom	Synexus Midlands Clinical Research Center	Edgbaston	Birmingham
United Kingdom	Synexus Scotland Clinical Research Center	Glasgow	Scottland
United Kingdom	Hospital for Tropical Diseases	London
United Kingdom	Guy's Drug Research Unit	London Bridge	London
United Kingdom	Synexus Thames Valley Clinical Research Center	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
Intercell USA, Inc.

Countries where clinical trial is conducted

Germany,  Guatemala,  Mexico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cases with vaccine preventable outcome		Day 17 (17 days after arrival in destination country)	No
Secondary	The incidence of moderate/severe diarrhea		Day 17 (17 days after arrival in destination country)	No
Secondary	Total unformed stool frequency from diarrheal episodes		Day 17 (17 days after arrival in destination country)	No
Secondary	Total duration of diarrheal episodes		Day 17 (17 days after arrival in destination country)	No