Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study

Traveler's Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01040325
• Other study ID #: ELT209
• Secondary ID: EudraCT Number:
• Status: Completed
• Phase: Phase 2
• First received: December 25, 2009
• Last updated: March 13, 2012
• Start date: December 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: Intercell USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of IndiaGermany: Paul-Ehrlich-InstitutUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 723
• Est. completion date: December 2010
• Est. primary completion date: June 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 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 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
• Traveler's Diarrhea

Intervention

Biological:
• TD Vaccine System
TD Vaccine System containing heat labile enterotoxin of E. coli (LT)
• TD Vaccine System
TD Vaccine System Containing Placebo Product

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Intercell USA, Inc.

Countries where clinical trial is conducted

Germany,  India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of cases with vaccine preventable outcome		within 17 days after arrival in destination country	No
Secondary	Incidence of moderate/severe diarrhea		within 17 days after arrival in destination country	No

External Links

•   Intercell Homepage