Clinical trial NCT01040325: Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Traveler's Diarrhea
Lead sponsor: Intercell USA, Inc.
Sponsor class: INDUSTRY
First posted: 2009-12-29
Enrollment: 723
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of cases with vaccine preventable outcome
timeFrame: within 17 days after arrival in destination country
Secondary outcomes:
measure: Incidence of moderate/severe diarrhea
timeFrame: within 17 days after arrival in destination country
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Belinger Centrum Reise & Tropenmedizin
city: Hamburg
country: Germany
facility: Tropical Medicine and Bernhard-Nocht Ints
city: Goa
country: India
facility: Dr. Tito's Health Care and Diagnostic Centre
city: Goa
country: India
facility: Prabhugaunker's Clinic
city: Kolkata
country: India
facility: Wellesley Medicentre
city: New Delhi
country: India
facility: Pushpawati Singhania Research Institute
city: Varanasi
country: India
facility: Samvedna Hospital
city: Reading
country: United Kingdom
facility: Synexus
state: Berkshire
city: Belfast
country: United Kingdom
facility: Bio-Kinetic Europe Ltd
state: Northern Ireland
city: Chorley
country: United Kingdom
facility: Synexus Ltd
city: London
country: United Kingdom
facility: Guy's Drug Research Unit
city: London
country: United Kingdom
facility: Hospital for Tropical Diseases
Study officials:
affiliation: University of Zurich
name: Robert Steffen, MD
role: PRINCIPAL_INVESTIGATOR
References: