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Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study

Sponsor
Intercell USA, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01040325
Collaborator
(none)
723
Enrollment
12
Locations
2
Arms
12
Duration (Months)
60.3
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: TD Vaccine System
  • Biological: TD Vaccine System
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
723 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase Two, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System in Travelers to Asia
Study Start Date :
Dec 1, 2009
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

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)
Placebo Comparator: Placebo

358 subjects receive a two vaccination regimen with placebo patch

Biological: TD Vaccine System
TD Vaccine System Containing Placebo Product

Outcome Measures

Primary Outcome Measures

  1. Incidence of cases with vaccine preventable outcome [within 17 days after arrival in destination country]

Secondary Outcome Measures

  1. Incidence of moderate/severe diarrhea [within 17 days after arrival in destination country]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Belinger Centrum Reise & Tropenmedizin Berlin Germany
2 Tropical Medicine and Bernhard-Nocht Ints Hamburg Germany
3 Dr. Tito's Health Care and Diagnostic Centre Goa India 403516
4 Prabhugaunker's Clinic Goa India 403721
5 Wellesley Medicentre Kolkata India
6 Pushpawati Singhania Research Institute New Delhi India 110017
7 Samvedna Hospital Varanasi India
8 Synexus Reading Berkshire United Kingdom
9 Bio-Kinetic Europe Ltd Belfast Northern Ireland United Kingdom BT2 7 BA
10 Synexus Ltd Chorley United Kingdom
11 Guy's Drug Research Unit London United Kingdom
12 Hospital for Tropical Diseases London United Kingdom

Sponsors and Collaborators

  • Intercell USA, Inc.

Investigators

  • Principal Investigator: Robert Steffen, MD, University of Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT01040325
Other Study ID Numbers:
  • ELT209
  • EudraCT Number: 2009-015603-10
First Posted:
Dec 29, 2009
Last Update Posted:
Mar 14, 2012
Last Verified:
Jan 1, 2012
Additional relevant MeSH terms:
Dysentery
Diarrhea
Vaccines

Study Results

No Results Posted as of Mar 14, 2012