Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing

Official Title
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A Phase 2, Gender-Stratified, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Two Vaccination Regimen With the Travelers' Diarrhea Vaccine System in Healthy Adults

Conditions
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Diarrhea

Intervention / Treatment
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* Biological: Heat-Labile Enterotoxin of E. coli (LT)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A female or male 18-64 (inclusive) years of age; In good health as determined by medical history and screening exam; Females who are post-menopausal, surgically sterile, or have a negative serum/urine pregnancy test at Day 0 and agree not to become pregnant for the duration of study. Exclusion Criteria: Abnormalities at physical exam [as determined by the Toxicity Grading Scale (Grade 1-4)]; Laboratory abnormalities [as determined by the Toxicity Grading Scale (Grade 1 4)] at screening; Participated in research involving investigational product within 30 days before planned date of first vaccination; Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd; Women who are pregnant or breastfeeding; Clinically significant underlying enteric, pulmonary, cardiac or renal disease; Current seizure disorder; Current use of immunosuppressive therapy (inhaled steroids are allowed); Known or suspected alcohol abuse or illicit drug use within the last year; Positive Serology for HIV-1, HIV-2, HbsAg, or HCV; Known allergies to any component of the vaccine including adhesives; An employee of the study site; An employee of Intercell (global) or an immediate family member; Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites; Receipt of any routine vaccinations within 7 days prior to, or following, the date of planned study vaccinations.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Two vaccination regimen with an LT patch (no swabbing) | Biological: Heat-Labile Enterotoxin of E. coli (LT)<br>* Travelers' Diarrhea Vaccine System<br>|
| Experimental: 2<br>Two vaccination regimen with an LT patch (with swabbing) | Biological: Heat-Labile Enterotoxin of E. coli (LT)<br>* Travelers' Diarrhea Vaccine System<br>|
| Placebo Comparator: 3<br>Two vaccination regimen with a placebo patch (no swabbing) | Biological: Placebo<br>* Travelers' Diarrhea Vaccine System<br>|
| Placebo Comparator: 4<br>Two vaccination regimen with a placebo patch (with swabbing) | Biological: Placebo<br>* Travelers' Diarrhea Vaccine System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs | Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited. | Day 0 to Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | LT immunoglobulin G (IgG) and immunoglobulin A (IgA) | Day 0 to Day 180 | 
| Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT immunoglobulin G (IgG) and immunoglobulin A (IgA) | Day 0 to Day 180 | 
| Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT immunoglobulin G (IgG) and immunoglobulin A (IgA) | Day 0 to Day 180 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention of Travelers' Diarrhea