Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067781
• Other study ID #: ELT208
• Status: Completed
• Phase: Phase 2
• Start date: February 2010
• Est. completion date: March 2012

Study information

• Verified date: February 2020
• Source: Intercell USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea

Intervention

Biological:
• Heat-Labile Enterotoxin of E. coli (LT)
Travelers' Diarrhea Vaccine System
• Placebo
Travelers' Diarrhea Vaccine System

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Radiant Research	Cincinnati	Ohio
United States	Johnson County Clinical Trials	Lenexa	Kansas
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Miami Research Associates	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Intercell USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Intercell Home Page