To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.
Name: heat-labile enterotoxin of E. coli (LT)
Description: Travelers' Diarrhea Vaccine SystemType: BiologicalGroup 1: 37.5 µg LT patch
Name: Placebo
Description: Travelers' Diarrhea Vaccine SystemType: BiologicalGroup 2: 0 µg LT patch (placebo)
Description: GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.
Measure: Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo Time: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194Description: Definition of SCR: Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline
Measure: Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo Time: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194Allocation: Randomized
Parallel Assignment
There is one SNP
Exclusion Criteria: - Laboratory abnormalities [as determined by the Toxicity Grading Scale (grade 1 4)] at laboratory screening - Abnormalities at physical examination [as determined by the Toxicity Grading Scale (grade 1-4)] - Known allergies to any component of the vaccine - Known allergies to adhesives - Participated in research involving investigational product within 30 days before planned date of first vaccination or within 90 days after first vaccination - Donated blood or blood products such as plasma within 30 days prior to planned date of first vaccination or within 90 days after first vaccination - Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd - Ever received cholera toxin or vaccine (e.g. --- R192G ---