Trial Outcomes & Findings for LT Vaccine Patch Self-Administration Study (NCT NCT00565461)
NCT ID: NCT00565461
Last Updated: 2020-03-30
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
160 participants
Primary outcome timeframe
Day 0, Day 14, Day 21, Day 28, Day 35, Day 194
Results posted on
2020-03-30
Participant Flow
Participant milestones
| Measure |
Clinician Administered (Deltoid)
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Clinician Administered (Thigh)
40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Self Administered (In-clinic)
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Self Administered (Non-clinic)
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
39
|
39
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LT Vaccine Patch Self-Administration Study
Baseline characteristics by cohort
| Measure |
Clinician Administered (Deltoid)
n=40 Participants
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Clinician Administered (Thigh)
n=40 Participants
40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Self Administered (In-clinic)
n=40 Participants
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Self Administered (Non-clinic)
n=40 Participants
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 12.21 • n=5 Participants
|
35.0 years
STANDARD_DEVIATION 11.10 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 11.18 • n=5 Participants
|
34.1 years
STANDARD_DEVIATION 11.18 • n=4 Participants
|
36.0 years
STANDARD_DEVIATION 11.02 • n=21 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
40 participants
n=5 Participants
|
40 participants
n=4 Participants
|
160 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0, Day 14, Day 21, Day 28, Day 35, Day 194Population: intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology
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
Outcome measures
| Measure |
Clinician Administered (Deltoid/ Thigh)
n=41 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: administered by clinician; location: thigh
|
Self Administered (In-clinic & Non-clinic)
n=80 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh
|
Group 3
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Group 4
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG GMTs - Day 0
|
362 geometric mean titers
Interval 264.0 to 496.0
|
442 geometric mean titers
Interval 354.0 to 552.0
|
—
|
—
|
|
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG GMTs - Day 14
|
1974 geometric mean titers
Interval 1196.0 to 3258.0
|
2896 geometric mean titers
Interval 2032.0 to 4127.0
|
—
|
—
|
|
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG GMTs - Day 21
|
4747 geometric mean titers
Interval 3232.0 to 6973.0
|
7545 geometric mean titers
Interval 5759.0 to 9886.0
|
—
|
—
|
|
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG GMTs - Day 28
|
11153 geometric mean titers
Interval 8255.0 to 15068.0
|
12180 geometric mean titers
Interval 9832.0 to 15089.0
|
—
|
—
|
|
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG GMTs - Day 35
|
12165 geometric mean titers
Interval 9320.0 to 15877.0
|
12745 geometric mean titers
Interval 10519.0 to 15442.0
|
—
|
—
|
|
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG GMTs - Day 194
|
4997 geometric mean titers
Interval 3753.0 to 6654.0
|
6035 geometric mean titers
Interval 4917.0 to 7409.0
|
—
|
—
|
|
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA GMTs - Day 0
|
54 geometric mean titers
Interval 41.0 to 69.0
|
53 geometric mean titers
Interval 44.0 to 64.0
|
—
|
—
|
|
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA GMTs - Day 14
|
218 geometric mean titers
Interval 142.0 to 335.0
|
365 geometric mean titers
Interval 270.0 to 494.0
|
—
|
—
|
|
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA GMTs - Day 21
|
430 geometric mean titers
Interval 309.0 to 598.0
|
639 geometric mean titers
Interval 507.0 to 806.0
|
—
|
—
|
|
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA GMTs - Day 28
|
632 geometric mean titers
Interval 462.0 to 864.0
|
768 geometric mean titers
Interval 615.0 to 960.0
|
—
|
—
|
|
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA GMTs - Day 35
|
548 geometric mean titers
Interval 397.0 to 757.0
|
712 geometric mean titers
Interval 564.0 to 898.0
|
—
|
—
|
|
GMTs After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA GMTs - Day 194
|
254 geometric mean titers
Interval 190.0 to 341.0
|
287 geometric mean titers
Interval 233.0 to 354.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14, Day 21, Day 28, Day 35, Day 194Population: intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology
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.
Outcome measures
| Measure |
Clinician Administered (Deltoid/ Thigh)
n=41 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: administered by clinician; location: thigh
|
Self Administered (In-clinic & Non-clinic)
n=80 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh
|
Group 3
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Group 4
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG GMFR - Day 35
|
34 geometric mean fold ratio
Interval 23.0 to 49.0
|
29 geometric mean fold ratio
Interval 22.0 to 38.0
|
—
|
—
|
|
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG GMFR - Day 14
|
6 geometric mean fold ratio
Interval 4.0 to 8.0
|
7 geometric mean fold ratio
Interval 5.0 to 9.0
|
—
|
—
|
|
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG GMFR - Day 21
|
14 geometric mean fold ratio
Interval 9.0 to 20.0
|
17 geometric mean fold ratio
Interval 13.0 to 23.0
|
—
|
—
|
|
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG GMFR - Day 28
|
31 geometric mean fold ratio
Interval 22.0 to 44.0
|
28 geometric mean fold ratio
Interval 21.0 to 36.0
|
—
|
—
|
|
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG GMFR - Day 194
|
14 geometric mean fold ratio
Interval 10.0 to 20.0
|
14 geometric mean fold ratio
Interval 11.0 to 18.0
|
—
|
—
|
|
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA GMFR - Day 14
|
4 geometric mean fold ratio
Interval 3.0 to 6.0
|
7 geometric mean fold ratio
Interval 5.0 to 9.0
|
—
|
—
|
|
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA GMFR - Day 21
|
8 geometric mean fold ratio
Interval 5.0 to 11.0
|
12 geometric mean fold ratio
Interval 10.0 to 15.0
|
—
|
—
|
|
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA GMFR - Day 28
|
12 geometric mean fold ratio
Interval 9.0 to 16.0
|
15 geometric mean fold ratio
Interval 12.0 to 18.0
|
—
|
—
|
|
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA GMFR - Day 35
|
10 geometric mean fold ratio
Interval 7.0 to 15.0
|
13 geometric mean fold ratio
Interval 11.0 to 17.0
|
—
|
—
|
|
GMFR After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA GMFR - Day 194
|
5 geometric mean fold ratio
Interval 4.0 to 6.0
|
5 geometric mean fold ratio
Interval 4.0 to 7.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14, Day 21, Day 28, Day 35, Day 194Population: intent to treat population = primary analysis population; defined as all study subjects who were consented, randomized, and had a baseline serology
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
Outcome measures
| Measure |
Clinician Administered (Deltoid/ Thigh)
n=41 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: administered by clinician; location: thigh
|
Self Administered (In-clinic & Non-clinic)
n=80 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh
|
Group 3
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Group 4
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG SCR - Day 28
|
98 percentage of study participants
Interval 87.0 to 100.0
|
99 percentage of study participants
Interval 93.0 to 100.0
|
—
|
—
|
|
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG SCR - Day 194
|
97 percentage of study participants
Interval 87.0 to 100.0
|
100 percentage of study participants
Interval 95.0 to 100.0
|
—
|
—
|
|
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA SCR - Day 14
|
48 percentage of study participants
Interval 32.0 to 64.0
|
59 percentage of study participants
Interval 47.0 to 70.0
|
—
|
—
|
|
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA SCR - Day 21
|
69 percentage of study participants
Interval 52.0 to 83.0
|
85 percentage of study participants
Interval 75.0 to 92.0
|
—
|
—
|
|
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA SCR - Day 28
|
83 percentage of study participants
Interval 67.0 to 93.0
|
90 percentage of study participants
Interval 81.0 to 96.0
|
—
|
—
|
|
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA SCR - Day 35
|
80 percentage of study participants
Interval 64.0 to 91.0
|
87 percentage of study participants
Interval 77.0 to 94.0
|
—
|
—
|
|
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgA SCR - Day 194
|
69 percentage of study participants
Interval 52.0 to 83.0
|
62 percentage of study participants
Interval 50.0 to 73.0
|
—
|
—
|
|
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG SCR - Day 14
|
65 percentage of study participants
Interval 48.0 to 79.0
|
73 percentage of study participants
Interval 61.0 to 82.0
|
—
|
—
|
|
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG SCR - Day 21
|
92 percentage of study participants
Interval 79.0 to 98.0
|
98 percentage of study participants
Interval 91.0 to 100.0
|
—
|
—
|
|
Seroconversion After a Self-administered LT Vaccine Patch (In-clinic or Away From Clinic) Compared to a Clinician-administered LT Vaccine Patch.
LT IgG SCR - Day 35
|
100 percentage of study participants
Interval 91.0 to 100.0
|
99 percentage of study participants
Interval 93.0 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Number analyzed in the Outcome Measure Data Teble are the number of subjects with events
Outcome measures
| Measure |
Clinician Administered (Deltoid/ Thigh)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: administered by clinician; location: thigh
|
Self Administered (In-clinic & Non-clinic)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh
|
Group 3
n=40 Participants
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Group 4
n=40 Participants
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
All AEs
|
347 Events
|
358 Events
|
358 Events
|
387 Events
|
|
Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
Local AEs
|
284 Events
|
283 Events
|
268 Events
|
304 Events
|
|
Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
Systemic AEs
|
63 Events
|
75 Events
|
90 Events
|
83 Events
|
|
Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
All Severe AEs
|
3 Events
|
9 Events
|
2 Events
|
7 Events
|
|
Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
Severe Systemic AEs
|
3 Events
|
9 Events
|
2 Events
|
7 Events
|
|
Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
All Related AEs
|
299 Events
|
297 Events
|
285 Events
|
334 Events
|
|
Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
Related Local AEs
|
284 Events
|
283 Events
|
268 Events
|
304 Events
|
|
Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
Related Systemic AEs
|
15 Events
|
14 Events
|
17 Events
|
30 Events
|
|
Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
All Serious AEs
|
2 Events
|
3 Events
|
—
|
—
|
|
Number of Adverse Events for Self-administered LT Vaccine Patch and Comparison to the Clinician-administered LT Vaccine Patch
Serious Systemic AEs
|
2 Events
|
3 Events
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.
Outcome measures
| Measure |
Clinician Administered (Deltoid/ Thigh)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: administered by clinician; location: thigh
|
Self Administered (In-clinic & Non-clinic)
n=41 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh
|
Group 3
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Group 4
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
LT IgG Day 0 - GMT
|
411 titers
Interval 302.0 to 561.0
|
362 titers
Interval 265.0 to 493.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
LT IgG Day 14 - GMT
|
2176 titers
Interval 1326.0 to 3571.0
|
1974 titers
Interval 1203.0 to 3240.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
LT IgG Day 21 - GMT
|
6292 titers
Interval 4136.0 to 9173.0
|
4747 titers
Interval 3241.0 to 6954.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
LT IgG Day 28 - GMT
|
8895 titers
Interval 6453.0 to 12263.0
|
11153 titers
Interval 8090.0 to 15375.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
LT IgG Day 35 - GMT
|
12460 titers
Interval 9639.0 to 16106.0
|
12165 titers
Interval 9410.0 to 15725.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
LT IgG Day 194 - GMT
|
6694 titers
Interval 5095.0 to 8795.0
|
4997 titers
Interval 3790.0 to 6589.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
LT IgA Day 0 - GMT
|
43 titers
Interval 33.0 to 56.0
|
54 titers
Interval 41.0 to 70.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
LT IgA Day 14 - GMT
|
239 titers
Interval 155.0 to 368.0
|
218 titers
Interval 142.0 to 337.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
LT IgA Day 21 - GMT
|
502 titers
Interval 358.0 to 703.0
|
430 titers
Interval 306.0 to 605.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
LT IgA Day 28 - GMT
|
610 titers
Interval 444.0 to 839.0
|
632 titers
Interval 460.0 to 869.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
LT IgA Day 35 - GMT
|
567 titers
Interval 419.0 to 767.0
|
548 titers
Interval 405.0 to 742.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine.
LT IgA Day 194 - GMT
|
272 titers
Interval 206.0 to 360.0
|
254 titers
Interval 192.0 to 337.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Number Analyzed in Outcome Measure Data Table: in Group 3 only 39 subjects received the second vaccination.
Outcome measures
| Measure |
Clinician Administered (Deltoid/ Thigh)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: administered by clinician; location: thigh
|
Self Administered (In-clinic & Non-clinic)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh
|
Group 3
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Group 4
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Erythema - 1st vaccination
|
37 Events
|
38 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Rash - 1st vaccination
|
35 Events
|
38 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Rash - 2nd vaccination
|
20 Events
|
23 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Pruritus - 1st vaccination
|
37 Events
|
31 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Pruiruts - 2nd vaccination
|
23 Events
|
29 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Hyperpigmentation - 1st vaccination
|
16 Events
|
23 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Hyperpigmentation - 2nd vaccination
|
7 Events
|
14 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Edema - 1st vaccination
|
5 Events
|
5 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Edema - 2nd vaccination
|
7 Events
|
5 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Pain - 1st vaccination
|
6 Events
|
8 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Pain - 2nd vaccination
|
5 Events
|
4 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Fever - 1st vaccination
|
1 Events
|
0 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Fever - 2nd vaccination
|
0 Events
|
1 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Malaise - 1st vaccination
|
3 Events
|
4 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Erythema - 2nd vaccination
|
33 Events
|
36 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Malaise - 2nd vaccination
|
3 Events
|
3 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Headache - 1st vaccination
|
7 Events
|
5 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Headache - 2nd vaccination
|
9 Events
|
4 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Diarrhea - 1st vaccination
|
6 Events
|
4 Events
|
—
|
—
|
|
Safety for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
Diarrhea - 2nd vaccination
|
3 Events
|
4 Events
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The Number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.
Outcome measures
| Measure |
Clinician Administered (Deltoid/ Thigh)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: administered by clinician; location: thigh
|
Self Administered (In-clinic & Non-clinic)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh
|
Group 3
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Group 4
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
LT IgG Day 14 - GMT
|
2539 titers
Interval 1547.0 to 4166.0
|
3304 titers
Interval 2013.0 to 5422.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
LT IgG Day 21 - GMT
|
6511 titers
Interval 4444.0 to 9537.0
|
8712 titers
Interval 5976.0 to 12701.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
LT IgG Day 28 - GMT
|
10496 titers
Interval 7582.0 to 14528.0
|
14083 titers
Interval 10216.0 to 19414.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
LT IgG Day 194 - GMT
|
5712 titers
Interval 4332.0 to 7532.0
|
6396 titers
Interval 4815.0 to 8495.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
LT IgA Day 0 - GMT
|
54 titers
Interval 42.0 to 70.0
|
52 titers
Interval 40.0 to 68.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
LT IgA Day 21 - GMT
|
549 titers
Interval 390.0 to 772.0
|
742 titers
Interval 530.0 to 1039.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
LT IgA Day 28 - GMT
|
660 titers
Interval 478.0 to 911.0
|
891 titers
Interval 648.0 to 1225.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
LT IgA Day 35 - GMT
|
605 titers
Interval 445.0 to 821.0
|
842 titers
Interval 618.0 to 1148.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
LT IgA Day 194 - GMT
|
246 titers
Interval 186.0 to 327.0
|
338 titers
Interval 253.0 to 452.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
LT IgG Day 0 - GMT
|
473 titers
Interval 347.0 to 644.0
|
413 titers
Interval 303.0 to 564.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMT) for Self-administration In-clinic Compared to Self-administration Away From the Clinic.
LT IgG Day 35 - GMT
|
11995 titers
Interval 9249.0 to 15556.0
|
13564 titers
Interval 10424.0 to 17651.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.
Outcome measures
| Measure |
Clinician Administered (Deltoid/ Thigh)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: administered by clinician; location: thigh
|
Self Administered (In-clinic & Non-clinic)
n=41 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh
|
Group 3
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Group 4
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgG Day 14 - GMFR
|
5 fold change
Interval 4.0 to 8.0
|
6 fold change
Interval 4.0 to 8.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgG Day 21 - GMFR
|
15 fold change
Interval 10.0 to 23.0
|
14 fold change
Interval 9.0 to 20.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgG Day 28 - GMFR
|
22 fold change
Interval 15.0 to 32.0
|
31 fold change
Interval 21.0 to 46.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgG Day 35 - GMFR
|
30 fold change
Interval 21.0 to 44.0
|
34 fold change
Interval 23.0 to 49.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgG Day 194 - GMFR
|
16 fold change
Interval 12.0 to 23.0
|
14 fold change
Interval 10.0 to 20.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgA Day 14 - GMFR
|
6 fold change
Interval 4.0 to 8.0
|
4 fold change
Interval 3.0 to 6.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgA Day 21 - GMFR
|
12 fold change
Interval 8.0 to 16.0
|
8 fold change
Interval 5.0 to 11.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgA Day 28 - GMFR
|
14 fold change
Interval 10.0 to 19.0
|
12 fold change
Interval 9.0 to 16.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgA Day 35 - GMFR
|
13 fold change
Interval 10.0 to 18.0
|
10 fold change
Interval 8.0 to 14.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgA Day 194 - GMFR
|
6 fold change
Interval 5.0 to 8.0
|
5 fold change
Interval 4.0 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.
Outcome measures
| Measure |
Clinician Administered (Deltoid/ Thigh)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: administered by clinician; location: thigh
|
Self Administered (In-clinic & Non-clinic)
n=41 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh
|
Group 3
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Group 4
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgG Day 28 - SCR
|
98 Percent of Participants
Interval 87.0 to 100.0
|
97 Percent of Participants
Interval 87.0 to 100.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgG Day 35 - SCR
|
95 Percent of Participants
Interval 83.0 to 99.0
|
100 Percent of Participants
Interval 91.0 to 100.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgG Day 194 - SCR
|
98 Percent of Participants
Interval 87.0 to 100.0
|
97 Percent of Participants
Interval 87.0 to 100.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgA Day 14 - SCR
|
50 Percent of Participants
Interval 34.0 to 66.0
|
48 Percent of Participants
Interval 32.0 to 64.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgG Day 14 - SCR
|
70 Percent of Participants
Interval 54.0 to 83.0
|
65 Percent of Participants
Interval 48.0 to 79.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgG Day 21 - SCR
|
90 Percent of Participants
Interval 76.0 to 97.0
|
92 Percent of Participants
Interval 79.0 to 98.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgA Day 21 - SCR
|
80 Percent of Participants
Interval 64.0 to 91.0
|
69 Percent of Participants
Interval 52.0 to 83.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgA Day 28 - SCR
|
88 Percent of Participants
Interval 73.0 to 96.0
|
83 Percent of Participants
Interval 67.0 to 93.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgA Day 35 - SCR
|
90 Percent of Participants
Interval 76.0 to 97.0
|
80 Percent of Participants
Interval 64.0 to 91.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Deltoid/Thigh (Prime/Boost) Versus Deltoid/Deltoid Administered LT Vaccine
LT IgA Day 194 - SCR
|
70 Percent of Participants
Interval 54.0 to 83.0
|
69 Percent of Participants
Interval 52.0 to 83.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The Number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.
Outcome measures
| Measure |
Clinician Administered (Deltoid/ Thigh)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: administered by clinician; location: thigh
|
Self Administered (In-clinic & Non-clinic)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh
|
Group 3
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Group 4
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
Lt IgG Day 14 - GMFR
|
5 fold change
Interval 4.0 to 8.0
|
8 fold change
Interval 5.0 to 12.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgG Day 21 - GMFR
|
14 fold change
Interval 9.0 to 21.0
|
21 fold change
Interval 14.0 to 31.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgG Day 28 - GMFR
|
22 fold change
Interval 15.0 to 33.0
|
34 fold change
Interval 23.0 to 50.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgG Day 35 - GMFR
|
26 fold change
Interval 18.0 to 37.0
|
34 fold change
Interval 23.0 to 49.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgG Day 194 - GMFR
|
12 fold change
Interval 9.0 to 17.0
|
16 fold change
Interval 11.0 to 23.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgA Day 35 - GMFR
|
11 fold change
Interval 8.0 to 15.0
|
16 fold change
Interval 12.0 to 22.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgA Day 194 - GMFR
|
5 fold change
Interval 4.0 to 6.0
|
6 fold change
Interval 5.0 to 8.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgA Day 14 - GMFR
|
6 fold change
Interval 4.0 to 9.0
|
8 fold change
Interval 5.0 to 12.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgA Day 21 - GMFR
|
10 fold change
Interval 7.0 to 14.0
|
14 fold change
Interval 10.0 to 20.0
|
—
|
—
|
|
Evaluation of Immunogenicity (GMFR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgA Day 28 - GMFR
|
12 fold change
Interval 9.0 to 17.0
|
17 fold change
Interval 13.0 to 23.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Overall Number of Participants Analyzed are the number of subjects in the ITT Population in each group. The Number analyzed in the Outcome Measure Data Table are the number of subjects with non-missing data at the specified time point.
Outcome measures
| Measure |
Clinician Administered (Deltoid/ Thigh)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: administered by clinician; location: thigh
|
Self Administered (In-clinic & Non-clinic)
n=40 Participants
1. st vaccination: administered by clinician; location: deltoid
2. nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh
|
Group 3
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Group 4
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgG Day 14 - SCR
|
68 Percent of Participants
Interval 51.0 to 81.0
|
78 Percent of Participants
Interval 62.0 to 90.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgG Day 21 - SCR
|
97 Percent of Participants
Interval 87.0 to 100.0
|
98 Percent of Participants
Interval 87.0 to 100.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgG Day 194 - SCR
|
100 Percent of Participants
Interval 91.0 to 100.0
|
100 Percent of Participants
Interval 91.0 to 100.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgA Day 14 - SCR
|
58 Percent of Participants
Interval 41.0 to 73.0
|
60 Percent of Participants
Interval 43.0 to 75.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgA Day 21 - SCR
|
84 Percent of Participants
Interval 70.0 to 94.0
|
85 Percent of Participants
Interval 70.0 to 94.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgA Day 28 - SCR
|
92 Percent of Participants
Interval 79.0 to 98.0
|
88 Percent of Participants
Interval 73.0 to 96.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgA Day 35 - SCR
|
85 Percent of Participants
Interval 70.0 to 94.0
|
90 Percent of Participants
Interval 75.0 to 97.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgA Day 194 - SCR
|
56 Percent of Participants
Interval 40.0 to 72.0
|
68 Percent of Participants
Interval 50.0 to 82.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgG Day 28 - SCR
|
100 Percent of Participants
Interval 91.0 to 100.0
|
98 Percent of Participants
Interval 87.0 to 100.0
|
—
|
—
|
|
Evaluation of Immunogenicity (SCR) for Self-administration In-clinic Compared to Self-administration Away From the Clinic
LT IgG Day 35 - SCR
|
100 Percent of Participants
Interval 91.0 to 100.0
|
97 Percent of Participants
Interval 86.0 to 100.0
|
—
|
—
|
Adverse Events
Clinician Administered (Deltoid)
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Clinician Administered (Thigh)
Serious events: 3 serious events
Other events: 40 other events
Deaths: 0 deaths
Self Administered (In-clinic)
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Self Administered (Non-clinic)
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clinician Administered (Deltoid)
n=40 participants at risk
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Clinician Administered (Thigh)
n=40 participants at risk
40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Self Administered (In-clinic)
n=40 participants at risk
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Self Administered (Non-clinic)
n=40 participants at risk
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
0.00%
0/40
|
0.00%
0/40
|
|
Cardiac disorders
Brugada syndrome
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
0.00%
0/40
|
0.00%
0/40
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
0.00%
0/40
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
0.00%
0/40
|
Other adverse events
| Measure |
Clinician Administered (Deltoid)
n=40 participants at risk
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Clinician Administered (Thigh)
n=40 participants at risk
40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Self Administered (In-clinic)
n=40 participants at risk
40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
Self Administered (Non-clinic)
n=40 participants at risk
40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.
heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
2/40
|
20.0%
8/40
|
17.5%
7/40
|
15.0%
6/40
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40
|
5.0%
2/40
|
2.5%
1/40
|
2.5%
1/40
|
|
General disorders
Malaise
|
7.5%
3/40
|
7.5%
3/40
|
15.0%
6/40
|
17.5%
7/40
|
|
Infections and infestations
Influenza
|
2.5%
1/40
|
2.5%
1/40
|
2.5%
1/40
|
5.0%
2/40
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
5/40
|
5.0%
2/40
|
10.0%
4/40
|
12.5%
5/40
|
|
Infections and infestations
Sinusitis
|
0.00%
0/40
|
5.0%
2/40
|
2.5%
1/40
|
2.5%
1/40
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
3/40
|
7.5%
3/40
|
12.5%
5/40
|
5.0%
2/40
|
|
Injury, poisoning and procedural complications
Application site discoloration
|
65.0%
26/40
|
75.0%
30/40
|
50.0%
20/40
|
72.5%
29/40
|
|
Injury, poisoning and procedural complications
Application site erythema
|
97.5%
39/40
|
95.0%
38/40
|
92.5%
37/40
|
97.5%
39/40
|
|
Injury, poisoning and procedural complications
Application site edema
|
22.5%
9/40
|
30.0%
12/40
|
27.5%
11/40
|
20.0%
8/40
|
|
Injury, poisoning and procedural complications
Application site excoriation
|
0.00%
0/40
|
2.5%
1/40
|
7.5%
3/40
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
Application site pain
|
30.0%
12/40
|
20.0%
8/40
|
25.0%
10/40
|
22.5%
9/40
|
|
Injury, poisoning and procedural complications
Application site pruritus
|
97.5%
39/40
|
90.0%
36/40
|
92.5%
37/40
|
87.5%
35/40
|
|
Injury, poisoning and procedural complications
Application site rash
|
95.0%
38/40
|
95.0%
38/40
|
87.5%
35/40
|
95.0%
38/40
|
|
Injury, poisoning and procedural complications
Application site scab
|
0.00%
0/40
|
5.0%
2/40
|
2.5%
1/40
|
10.0%
4/40
|
|
Investigations
Blood glucose increased
|
0.00%
0/40
|
7.5%
3/40
|
5.0%
2/40
|
7.5%
3/40
|
|
Investigations
Protein urine present
|
5.0%
2/40
|
2.5%
1/40
|
2.5%
1/40
|
0.00%
0/40
|
|
Investigations
Red blood cells in urine
|
20.0%
8/40
|
7.5%
3/40
|
17.5%
7/40
|
10.0%
4/40
|
|
Nervous system disorders
Headache
|
15.0%
6/40
|
22.5%
9/40
|
30.0%
12/40
|
20.0%
8/40
|
|
Renal and urinary disorders
Hematuria
|
2.5%
1/40
|
0.00%
0/40
|
5.0%
2/40
|
2.5%
1/40
|
|
Renal and urinary disorders
Proteinuria
|
2.5%
1/40
|
5.0%
2/40
|
0.00%
0/40
|
2.5%
1/40
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.0%
2/40
|
2.5%
1/40
|
0.00%
0/40
|
10.0%
4/40
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
1/40
|
5.0%
2/40
|
0.00%
0/40
|
2.5%
1/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER