Traveler's Diarrhea (TD) Vaccine Asia Efficacy Study

Study Overview
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Brief Summary
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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.

Official Title
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A Phase Two, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System in Travelers to Asia

Conditions
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Traveler's Diarrhea

Intervention / Treatment
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* Biological: TD Vaccine System
* Biological: TD Vaccine System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>358 subjects receive a two vaccination regimen with an LT patch | Biological: TD Vaccine System<br>* TD Vaccine System containing heat labile enterotoxin of E. coli (LT)<br>|
| Placebo Comparator: Placebo<br>358 subjects receive a two vaccination regimen with placebo patch | Biological: TD Vaccine System<br>* TD Vaccine System Containing Placebo Product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cases with vaccine preventable outcome |  | within 17 days after arrival in destination country | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of moderate/severe diarrhea |  | within 17 days after arrival in destination country |