Clinical trial NCT01067781: Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diarrhea
Keywords: Prevention of Travelers' Diarrhea
Lead sponsor: Intercell USA, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Day 0 to Day 180
Secondary outcomes:
measure: Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
timeFrame: Day 0 to Day 180
measure: Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
timeFrame: Day 0 to Day 180
measure: Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
timeFrame: Day 0 to Day 180
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Lenexa
country: United States
facility: Johnson County Clinical Trials
state: Kansas
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: San Antonio
country: United States
facility: Clinical Trials of Texas
state: Texas
Study officials:
affiliation: Miami Research Associates
name: Eric Sheldon, MD
role: PRINCIPAL_INVESTIGATOR
References: