Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

Intercell

Status and phase: Completed; Phase 2

Conditions: Diarrhea

Treatments: Biological: Heat-Labile Enterotoxin of E. coli (LT); Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01067781

ELT208

Details and patient eligibility

About

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

Enrollment: 600 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

600 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Two vaccination regimen with an LT patch (no swabbing)

Treatment:

Biological: Heat-Labile Enterotoxin of E. coli (LT)

2

Experimental group

Description:

Two vaccination regimen with an LT patch (with swabbing)

Treatment:

Biological: Heat-Labile Enterotoxin of E. coli (LT)

3

Placebo Comparator group

Description:

Two vaccination regimen with a placebo patch (no swabbing)

Treatment:

Biological: Placebo

4

Placebo Comparator group

Description:

Two vaccination regimen with a placebo patch (with swabbing)

Treatment:

Biological: Placebo