Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

• ClinicalTrials.gov Identifier: NCT01067781
• Recruitment Status: Completed
• First Posted: February 12, 2010
• Results First Posted: March 13, 2014
• Last Update Posted: February 10, 2020
• Sponsor: Intercell USA, Inc.
• Information provided by (Responsible Party): Intercell USA, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Diarrhea	Biological: Heat-Labile Enterotoxin of E. coli (LT); Biological: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 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
• Study Start Date: February 2010
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: March 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: Day 0 to Day 180 ]
   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.

Secondary Outcome Measures :

1. Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers [ Time Frame: Day 0 to Day 180 ]
   LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
2. Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios [ Time Frame: Day 0 to Day 180 ]
   LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
3. Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates [ Time Frame: Day 0 to Day 180 ]
   LT immunoglobulin G (IgG) and immunoglobulin A (IgA)

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, California

Advanced Clinical Research Institute

Anaheim, California, United States, 92801

United States, Florida

Miami Research Associates

South Miami, Florida, United States, 33143

United States, Kansas

Johnson County Clinical Trials

Lenexa, Kansas, United States, 66219

United States, Ohio

Radiant Research

Cincinnati, Ohio, United States, 45249

United States, Texas

Clinical Trials of Texas

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Intercell USA, Inc.

Investigators

• Principal Investigator: Eric Sheldon, MD; Miami Research Associates

More Information

Additional Information:

Intercell Home Page 

• Responsible Party: Intercell USA, Inc.
• ClinicalTrials.gov Identifier: NCT01067781
• Other Study ID Numbers: ELT208
• First Posted: February 12, 2010
• Results First Posted: March 13, 2014
• Last Update Posted: February 10, 2020
• Last Verified: February 2020

Keywords provided by Intercell USA, Inc.:

Prevention of Travelers' Diarrhea

Additional relevant MeSH terms:

Diarrhea; Signs and Symptoms, Digestive