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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Travelers' Diarrhea Vaccine System
Travelers' Diarrhea Vaccine System
Solano Clinical Research
Vallejo, California, United States
Miami Research Associates
South Miami, Florida, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
Time frame: Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.
Time frame: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
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
Time frame: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
LT subjects (Group 1) were followed for six months longer (until Day 380) than Placebo subjects (Group 2) (until Day 194)
Time frame: 13 months
Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear
Time frame: 1 month
Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group
GMT
Time frame: 13 months
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
GMFR
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Time frame: 13 months
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
SCR
Time frame: 13 months