To evaluate the immune responses achieved following self-administered heat-labile enterotoxin of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses achieved by clinician-administered vaccination.
Name: heat-labile enterotoxin of E. coli (LT)
Description: 37.5ug patch applied on either the deltoid or the thighType: BiologicalGroup 1 Group 2 Group 3 Group 4
Description: The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMT: geometric mean titer
Measure: GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. Time: Day 0, Day 14, Day 21, Day 28, Day 35, Day 194Description: The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data.
Measure: GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. Time: Day 14, Day 21, Day 28, Day 35, Day 194Description: The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered [second] vaccination with clinician-administered [second] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. seroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA
Measure: Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch. Time: Day 14, Day 21, Day 28, Day 35, Day 194Allocation: Randomized
Parallel Assignment
There is one SNP
Exclusion Criteria: Subjects meeting any of the following criteria are not eligible for participation in the study: - 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 - Donated blood or blood products such as plasma within the past 30 days - Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd - Ever received cholera toxin or vaccine (e.g. --- R192G ---