Phase 2
N=600
Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch
Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT01067781 ↗Enrolled (actual)
600
Serious AEs
0.7%
Results posted
Mar 2014
Primary outcome: 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 — 318; 93; 327; 62 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Heat-Labile Enterotoxin of E. coli (LT) (Biological); Placebo (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intercell USA, Inc.
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
318; 93; 327; 62; 20; 3 | — |
| SECONDARY Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers |
442.21; 421.20; 435.64; 344.40; 455.68; 437.80 | — |
| SECONDARY Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios |
1.02; 1.04; 0.96; 1.02; 2.37; 2.73 | — |
| SECONDARY Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates |
7.18; 7.56; 3.33; 6.74; 47.51; 49.42 | — |
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
- 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;
- Known allergies to any component of the vaccine including adhesives;
- An employee of the study site;
- An employee of Intercell (global) or an immediate family member;
- Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites;
- Receipt of any routine vaccinations within 7 days prior to, or following, the date of planned study vaccinations.
Data sourced from ClinicalTrials.gov (NCT01067781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.