Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

Phase 2

Completed

• Conditions: Diarrhea
• Interventions: Biological: Placebo; Biological: Heat-Labile Enterotoxin of E. coli (LT)

• Registration Number: NCT01067781
• Lead Sponsor: Intercell USA, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-12
• Primary Completion: 2010-09
• Study Completion: 2012-03
• Results First Submitted: 2014-01-30
• Results First Submitted QC: 2014-01-30
• Results First Posted: 2014-03-13
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	Placebo	Two vaccination regimen with a placebo patch (with swabbing)
1	Heat-Labile Enterotoxin of E. coli (LT)	Two vaccination regimen with an LT patch (no swabbing)
3	Placebo	Two vaccination regimen with a placebo patch (no swabbing)
2	Heat-Labile Enterotoxin of E. coli (LT)	Two vaccination regimen with an LT patch (with swabbing)

Primary Outcome Measures

Name	Time	Method
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	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

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

Trial Locations

Locations (5)

Advanced Clinical Research Institute; 🇺🇸 Anaheim, California, United States

Miami Research Associates; 🇺🇸 South Miami, Florida, United States

Clinical Trials of Texas; 🇺🇸 San Antonio, Texas, United States

Johnson County Clinical Trials; 🇺🇸 Lenexa, Kansas, United States

Radiant Research; 🇺🇸 Cincinnati, Ohio, United States