Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

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

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

Study Overview

• Status: Completed
• Conditions: Diarrhea
• Intervention / Treatment: Biological: Placebo; Biological: Heat-Labile Enterotoxin of E. coli (LT)

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
  • Florida
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County Clinical Trials
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. A female or male 18-64 (inclusive) years of age;
2. In good health as determined by medical history and screening exam;
3. 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:

1. Abnormalities at physical exam [as determined by the Toxicity Grading Scale (Grade 1-4)];
2. Laboratory abnormalities [as determined by the Toxicity Grading Scale (Grade 1 4)] at screening;
3. Participated in research involving investigational product within 30 days before planned date of first vaccination;
4. Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd;
5. Women who are pregnant or breastfeeding;
6. Clinically significant underlying enteric, pulmonary, cardiac or renal disease;
7. Current seizure disorder;
8. Current use of immunosuppressive therapy (inhaled steroids are allowed);
9. Known or suspected alcohol abuse or illicit drug use within the last year;
10. Positive Serology for HIV-1, HIV-2, HbsAg, or HCV;
11. Known allergies to any component of the vaccine including adhesives;
12. An employee of the study site;
13. An employee of Intercell (global) or an immediate family member;
14. Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites;
15. Receipt of any routine vaccinations within 7 days prior to, or following, the date of planned study vaccinations.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Intercell USA, Inc.

Publications and helpful links

Helpful Links

• Intercell Home Page

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 11, 2010
• First Posted (Estimate): February 12, 2010

Study Record Updates

• Last Update Posted (Actual): February 10, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Prevention of Travelers' Diarrhea
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea
• Other Study ID Numbers: ELT208