Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study
Phase 2
Completed
- Conditions
- Traveler's Diarrhea
- Interventions
- Biological: TD Vaccine System
- Registration Number
- NCT01040325
- Lead Sponsor
- Intercell USA, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 723
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active TD Vaccine System 358 subjects receive a two vaccination regimen with an LT patch Placebo TD Vaccine System 358 subjects receive a two vaccination regimen with placebo patch
- Primary Outcome Measures
Name Time Method Incidence of cases with vaccine preventable outcome within 17 days after arrival in destination country
- Secondary Outcome Measures
Name Time Method Incidence of moderate/severe diarrhea within 17 days after arrival in destination country
Trial Locations
- Locations (12)
Dr. Tito's Health Care and Diagnostic Centre
🇮🇳Goa, India
Wellesley Medicentre
🇮🇳Kolkata, India
Prabhugaunker's Clinic
🇮🇳Goa, India
Bio-Kinetic Europe Ltd
🇬🇧Belfast, Northern Ireland, United Kingdom
Pushpawati Singhania Research Institute
🇮🇳New Delhi, India
Samvedna Hospital
🇮🇳Varanasi, India
Tropical Medicine and Bernhard-Nocht Ints
🇩🇪Hamburg, Germany
Belinger Centrum Reise & Tropenmedizin
🇩🇪Berlin, Germany
Synexus
🇬🇧Reading, Berkshire, United Kingdom
Guy's Drug Research Unit
🇬🇧London, United Kingdom
Synexus Ltd
🇬🇧Chorley, United Kingdom
Hospital for Tropical Diseases
🇬🇧London, United Kingdom