Gender-Stratified Safety and Immunogenicity Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT01067781
First received: February 9, 2010
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Diarrhea
Biological: Heat-Labile Enterotoxin of E. coli (LT)
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Intercell USA, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: (1) Geometric Mean Titers (2) Geometric Mean Fold Ratios (3) Seroconversion Rates [ Time Frame: Day 0 to Day 180 ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067781

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:
No publications provided

Responsible Party: Intercell USA, Inc.
ClinicalTrials.gov Identifier: NCT01067781     History of Changes
Other Study ID Numbers: ELT208
Study First Received: February 9, 2010
Results First Received: January 30, 2014
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Intercell USA, Inc.:
Prevention of Travelers' Diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014