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
Name: Heat-Labile Enterotoxin of E. coli (LT)
Description: Travelers' Diarrhea Vaccine SystemType: Biological1 2
Name: Placebo
Description: Travelers' Diarrhea Vaccine SystemType: Biological3 4
Description: 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.
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 Time: Day 0 to Day 180Description: LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Measure: Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers Time: Day 0 to Day 180Description: LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Measure: Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios Time: Day 0 to Day 180Description: LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Measure: Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates Time: Day 0 to Day 180Allocation: Randomized
Parallel Assignment
There is one SNP
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. --- R192G ---