Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study

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

The purpose of this study is to evaluate the efficacy of the TD Vaccine System to prevent moderate to severe enterotoxin E.coli (ETEC) disease in travelers to India.

Study Overview

• Status: Completed
• Conditions: Traveler's Diarrhea
• Intervention / Treatment: Biological: TD Vaccine System; Biological: TD Vaccine System

• Study Type: Interventional
• Enrollment (Actual): 723
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Belinger Centrum Reise & Tropenmedizin
  • Hamburg, Germany
    • Tropical Medicine and Bernhard-Nocht Ints
• India
  • Goa, India, 403516
    • Dr. Tito's Health Care and Diagnostic Centre
  • Goa, India, 403721
    • Prabhugaunker's Clinic
  • Kolkata, India
    • Wellesley Medicentre
  • New Delhi, India, 110017
    • Pushpawati Singhania Research Institute
  • Varanasi, India
    • Samvedna Hospital
• United Kingdom
  • Chorley, United Kingdom
    • Synexus Ltd
  • London, United Kingdom
    • Guy's Drug Research Unit
  • London, United Kingdom
    • Hospital For Tropical Diseases
  • Berkshire
    • Reading, Berkshire, United Kingdom
      • Synexus
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT2 7 BA
      • Bio-Kinetic Europe Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 and second vaccination in the country of origin; females of child-bearing potential must agree not to become pregnant throughout the duration of study
• Subjects must have planned travel to DC, within 3 hours traveling distance of approved study site(s), for a minimum duration of stay of 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 in 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 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 from two weeks prior to randomization through the surveillance phase of the study;
• An employee of Intercell (global) or an immediate family member.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; 358 subjects receive a two vaccination regimen with an LT patch	Biological: TD Vaccine System; TD Vaccine System containing heat labile enterotoxin of E. coli (LT); Biological: TD Vaccine System; TD Vaccine System Containing Placebo Product
Placebo Comparator: Placebo; 358 subjects receive a two vaccination regimen with placebo patch	Biological: TD Vaccine System; TD Vaccine System containing heat labile enterotoxin of E. coli (LT); Biological: TD Vaccine System; TD Vaccine System Containing Placebo Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of cases with vaccine preventable outcome	within 17 days after arrival in destination country

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of moderate/severe diarrhea	within 17 days after arrival in destination country

Collaborators and Investigators

• Sponsor: Intercell USA, Inc.
• Investigators: Principal Investigator: Robert Steffen, MD, University of Zurich

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 25, 2009
• First Submitted That Met QC Criteria: December 28, 2009
• First Posted (Estimate): December 29, 2009

Study Record Updates

• Last Update Posted (Estimate): March 14, 2012
• Last Update Submitted That Met QC Criteria: March 13, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Diarrhea; Dysentery; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: ELT209; EudraCT Number: 2009-015603-10