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

Intercell USA, Inc.5 sites in 1 country600 target enrollmentFebruary 2010

ConditionsDiarrhea

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Diarrhea
Sponsor: Intercell USA, Inc.
Enrollment: 600
Locations: 5
Primary Endpoint: 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
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

March 2012

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Intercell USA, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A female or male 18-64 (inclusive) years of age;
•In good health as determined by medical history and screening exam;
•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

•Abnormalities at physical exam \[as determined by the Toxicity Grading Scale (Grade 1-4)\];
•Laboratory abnormalities \[as determined by the Toxicity Grading Scale (Grade 1 4)\] at screening;
•Participated in research involving investigational product within 30 days before planned date of first vaccination;
•Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd;
•Women who are pregnant or breastfeeding;
•Clinically significant underlying enteric, pulmonary, cardiac or renal disease;
•Current seizure disorder;
•Current use of immunosuppressive therapy (inhaled steroids are allowed);
•Known or suspected alcohol abuse or illicit drug use within the last year;
•Positive Serology for HIV-1, HIV-2, HbsAg, or HCV;

Outcomes

Primary Outcomes

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

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 Outcomes

Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers(Day 0 to Day 180)
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios(Day 0 to Day 180)
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates(Day 0 to Day 180)