Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT01040325
First received: December 25, 2009
Last updated: March 13, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Traveler's Diarrhea
Biological: TD Vaccine System
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Intercell USA, Inc.:

Primary Outcome Measures:
  • Incidence of cases with vaccine preventable outcome [ Time Frame: within 17 days after arrival in destination country ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of moderate/severe diarrhea [ Time Frame: within 17 days after arrival in destination country ] [ Designated as safety issue: No ]

Enrollment: 723
Study Start Date: December 2009
Study Completion Date: December 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040325

Locations
Germany
Belinger Centrum Reise & Tropenmedizin
Berlin, Germany
Tropical Medicine and Bernhard-Nocht Ints
Hamburg, Germany
India
Prabhugaunker's Clinic
Goa, India, 403721
Dr. Tito's Health Care and Diagnostic Centre
Goa, India, 403516
Wellesley Medicentre
Kolkata, India
Pushpawati Singhania Research Institute
New Delhi, India, 110017
Samvedna Hospital
Varanasi, India
United Kingdom
Synexus
Reading, Berkshire, United Kingdom
Bio-Kinetic Europe Ltd
Belfast, Northern Ireland, United Kingdom, BT2 7 BA
Synexus Ltd
Chorley, United Kingdom
Guy's Drug Research Unit
London, United Kingdom
Hospital for Tropical Diseases
London, United Kingdom
Sponsors and Collaborators
Intercell USA, Inc.
Investigators
Principal Investigator: Robert Steffen, MD University of Zurich
  More Information

Additional Information:
No publications provided

Responsible Party: Intercell USA, Inc.
ClinicalTrials.gov Identifier: NCT01040325     History of Changes
Other Study ID Numbers: ELT209, EudraCT Number: 2009-015603-10
Study First Received: December 25, 2009
Last Updated: March 13, 2012
Health Authority: India: Drugs Controller General of India
Germany: Paul-Ehrlich-Institut
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Germany: Ethics Commission

Additional relevant MeSH terms:
Diarrhea
Dysentery
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 22, 2014