Trial Outcomes & Findings for Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch (NCT NCT01067781)
NCT ID: NCT01067781
Last Updated: 2020-02-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
600 participants
Primary outcome timeframe
Day 0 to Day 180
Results posted on
2020-02-10
Participant Flow
Participant milestones
| Measure |
Group 1: 37.5μg LT, No Swab
Two vaccination regimen with an LT patch (no swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 37.5μg LT, Swab
Two vaccination regimen with an LT patch (with swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 3: 0μg LT, No Swab
Two vaccination regimen with a placebo patch (no swabbing)
Placebo: Travelers' Diarrhea Vaccine System
|
Group 4: 0μg LT, Swab
Two vaccination regimen with a placebo patch (with swabbing)
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|---|---|
|
Up to Day 180
STARTED
|
203
|
199
|
97
|
101
|
|
Up to Day 180
COMPLETED
|
173
|
168
|
89
|
89
|
|
Up to Day 180
NOT COMPLETED
|
30
|
31
|
8
|
12
|
|
180 to Day 720
STARTED
|
173
|
168
|
89
|
89
|
|
180 to Day 720
COMPLETED
|
3
|
4
|
0
|
0
|
|
180 to Day 720
NOT COMPLETED
|
170
|
164
|
89
|
89
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch
Baseline characteristics by cohort
| Measure |
Group 1: 37.5μg LT, No Swab
n=203 Participants
Two vaccination regimen with an LT patch (no swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 37.5μg LT, Swab
n=199 Participants
Two vaccination regimen with an LT patch (with swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 3: 0μg LT, No Swab
n=97 Participants
Two vaccination regimen with a placebo patch (no swabbing)
Placebo: Travelers' Diarrhea Vaccine System
|
Group 4: 0μg LT, Swab
n=101 Participants
Two vaccination regimen with a placebo patch (with swabbing)
Placebo: Travelers' Diarrhea Vaccine System
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
35.3 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
35.0 years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
35.7 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
35.3 years
STANDARD_DEVIATION 13.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
300 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
300 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 0 to Day 180Erythema, 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.
Outcome measures
| Measure |
Group 1 & 2 Combined: 37.5µg LT Patch
n=402 Participants
with or without swabbing
|
Group 3 & 4 Combined: Placebo Patch (0µg LT)
n=198 Participants
with or without swabbing
|
Placebo Patch Without Swabbing
Two vaccination (Day 0 and Day 14) regimen with a placebo patch (no swabbing)
Placebo: Travelers' Diarrhea Vaccine System
|
Placebo Patch With Swabbing
Two vaccination (Day 0 and Day 14) regimen with a placebo patch (with swabbing)
SPS:Buffer-prepared site swabbed with a 70% isopropyl alcohol pad
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|---|---|
|
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
Solicited Local Adverse Events (1st vaccination)
|
318 participants
|
93 participants
|
—
|
—
|
|
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
Solicited Local AEs (2nd vaccination)
|
327 participants
|
62 participants
|
—
|
—
|
|
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
Non-solicited Local AEs (1st vaccination)
|
20 participants
|
3 participants
|
—
|
—
|
|
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
Non-solicited Local AEs (2nd vaccination)
|
11 participants
|
3 participants
|
—
|
—
|
|
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
Solicited Systemic AEs (overall)
|
134 participants
|
59 participants
|
—
|
—
|
|
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
Non-solicited Systemic AEs (overall)
|
296 participants
|
148 participants
|
—
|
—
|
|
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
Serious AEs
|
4 participants
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to Day 180Population: the numbers analyzed differs from the Overall number analyzed because for this the Immunogenicity Evaluable Population (IEP) was used: includes all study subjects that were consented, randomized, received the assigned Treatments (both vaccinations) without significant protocol deviations and had blood drawn on Day 0, Day 21 and Day 35
LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Outcome measures
| Measure |
Group 1 & 2 Combined: 37.5µg LT Patch
n=182 Participants
with or without swabbing
|
Group 3 & 4 Combined: Placebo Patch (0µg LT)
n=173 Participants
with or without swabbing
|
Placebo Patch Without Swabbing
n=92 Participants
Two vaccination (Day 0 and Day 14) regimen with a placebo patch (no swabbing)
Placebo: Travelers' Diarrhea Vaccine System
|
Placebo Patch With Swabbing
n=90 Participants
Two vaccination (Day 0 and Day 14) regimen with a placebo patch (with swabbing)
SPS:Buffer-prepared site swabbed with a 70% isopropyl alcohol pad
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|---|---|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgG Day 28
|
4010.55 titers
Interval 3424.12 to 4697.41
|
4806.53 titers
Interval 4057.6 to 5693.69
|
571.09 titers
Interval 463.6 to 703.49
|
418.78 titers
Interval 353.08 to 496.69
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgG Day 35
|
4820.85 titers
Interval 4121.82 to 5638.42
|
6005.34 titers
Interval 5126.11 to 7035.37
|
573.03 titers
Interval 471.04 to 697.12
|
421.34 titers
Interval 359.37 to 494.01
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgG Day 42
|
5229.02 titers
Interval 4526.96 to 6039.96
|
5757.21 titers
Interval 4949.95 to 6696.11
|
582.72 titers
Interval 469.17 to 723.76
|
427.64 titers
Interval 357.27 to 511.86
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgG Day 56
|
5056.13 titers
Interval 4380.77 to 5835.6
|
5633.07 titers
Interval 4910.89 to 6461.46
|
588.69 titers
Interval 484.87 to 714.74
|
411.26 titers
Interval 340.9 to 496.15
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgG Day 90
|
4833.84 titers
Interval 4231.66 to 5521.71
|
4695.02 titers
Interval 4085.96 to 5394.87
|
537.23 titers
Interval 440.47 to 655.24
|
464.11 titers
Interval 390.5 to 551.61
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgG Day 180
|
2809.18 titers
Interval 2440.4 to 3233.67
|
2843.59 titers
Interval 2486.76 to 3251.61
|
498.20 titers
Interval 404.73 to 613.24
|
419.89 titers
Interval 354.8 to 496.93
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgA Day 0
|
72.71 titers
Interval 65.1 to 81.22
|
67.06 titers
Interval 60.62 to 74.18
|
63.00 titers
Interval 55.53 to 71.46
|
69.52 titers
Interval 59.9 to 80.69
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgA Day 7
|
74.30 titers
Interval 66.09 to 83.52
|
65.29 titers
Interval 58.7 to 72.62
|
62.26 titers
Interval 54.81 to 70.72
|
70.77 titers
Interval 60.62 to 82.61
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgA Day 14
|
130.89 titers
Interval 112.1 to 152.83
|
132.33 titers
Interval 111.62 to 156.87
|
59.70 titers
Interval 53.47 to 66.67
|
69.79 titers
Interval 59.78 to 81.48
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgA Day 21
|
183.42 titers
Interval 155.55 to 216.29
|
175.05 titers
Interval 147.46 to 207.79
|
65.82 titers
Interval 56.12 to 77.18
|
69.91 titers
Interval 59.83 to 81.68
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgA Day 28
|
290.95 titers
Interval 251.96 to 335.99
|
294.68 titers
Interval 252.19 to 344.34
|
67.52 titers
Interval 57.86 to 78.79
|
76.00 titers
Interval 64.41 to 89.66
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgA Day 35
|
284.26 titers
Interval 247.37 to 326.66
|
286.88 titers
Interval 245.46 to 335.29
|
69.84 titers
Interval 60.23 to 80.99
|
74.91 titers
Interval 63.19 to 88.81
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgA Day 42
|
248.33 titers
Interval 214.74 to 287.17
|
261.53 titers
Interval 223.84 to 305.58
|
67.45 titers
Interval 58.3 to 78.03
|
71.97 titers
Interval 61.24 to 84.57
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgA Day 56
|
229.76 titers
Interval 198.94 to 265.34
|
232.70 titers
Interval 200.49 to 270.09
|
70.11 titers
Interval 59.62 to 82.44
|
78.60 titers
Interval 66.3 to 93.2
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgA Day 90
|
168.18 titers
Interval 144.93 to 195.16
|
166.85 titers
Interval 142.94 to 194.75
|
61.79 titers
Interval 53.98 to 70.73
|
70.93 titers
Interval 60.92 to 82.59
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgA Day 180
|
120.12 titers
Interval 104.49 to 138.08
|
124.50 titers
Interval 107.41 to 144.3
|
56.00 titers
Interval 50.0 to 62.72
|
61.30 titers
Interval 53.98 to 69.6
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgG Day 0
|
442.21 titers
Interval 386.83 to 505.53
|
421.20 titers
Interval 368.78 to 481.06
|
435.64 titers
Interval 360.89 to 525.89
|
344.40 titers
Interval 282.43 to 419.98
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgG Day 7
|
455.68 titers
Interval 402.07 to 516.44
|
437.80 titers
Interval 380.75 to 503.39
|
426.28 titers
Interval 352.98 to 514.81
|
348.13 titers
Interval 289.47 to 418.67
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgG Day 14
|
1042.41 titers
Interval 862.9 to 1259.26
|
1148.98 titers
Interval 940.12 to 1404.24
|
433.13 titers
Interval 357.98 to 524.06
|
336.41 titers
Interval 276.48 to 409.34
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers
IgG Day 21
|
2036.77 titers
Interval 1678.75 to 2471.14
|
2537.89 titers
Interval 2073.46 to 3106.35
|
447.47 titers
Interval 371.36 to 539.18
|
404.66 titers
Interval 332.68 to 492.21
|
SECONDARY outcome
Timeframe: Day 0 to Day 180Population: the numbers analyzed differs from the Overall number analyzed because for this the Immunogenicity Evaluable Population (IEP) was used: includes all study subjects that were consented, randomized, received the assigned Treatments (both vaccinations) without significant protocol deviations and had blood drawn on Day 0, Day 21 and Day 35
LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Outcome measures
| Measure |
Group 1 & 2 Combined: 37.5µg LT Patch
n=182 Participants
with or without swabbing
|
Group 3 & 4 Combined: Placebo Patch (0µg LT)
n=173 Participants
with or without swabbing
|
Placebo Patch Without Swabbing
n=92 Participants
Two vaccination (Day 0 and Day 14) regimen with a placebo patch (no swabbing)
Placebo: Travelers' Diarrhea Vaccine System
|
Placebo Patch With Swabbing
n=90 Participants
Two vaccination (Day 0 and Day 14) regimen with a placebo patch (with swabbing)
SPS:Buffer-prepared site swabbed with a 70% isopropyl alcohol pad
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|---|---|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgG Day 7
|
1.02 Geometric Mean Fold Ratios (GMFRs)
Interval 0.95 to 1.09
|
1.04 Geometric Mean Fold Ratios (GMFRs)
Interval 0.97 to 1.12
|
0.96 Geometric Mean Fold Ratios (GMFRs)
Interval 0.89 to 1.04
|
1.02 Geometric Mean Fold Ratios (GMFRs)
Interval 0.95 to 1.1
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgG Day 14
|
2.37 Geometric Mean Fold Ratios (GMFRs)
Interval 2.01 to 2.81
|
2.73 Geometric Mean Fold Ratios (GMFRs)
Interval 2.26 to 3.31
|
0.99 Geometric Mean Fold Ratios (GMFRs)
Interval 0.92 to 1.07
|
0.98 Geometric Mean Fold Ratios (GMFRs)
Interval 0.9 to 1.06
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgG Day 21
|
4.61 Geometric Mean Fold Ratios (GMFRs)
Interval 3.76 to 5.65
|
6.03 Geometric Mean Fold Ratios (GMFRs)
Interval 4.86 to 7.47
|
1.03 Geometric Mean Fold Ratios (GMFRs)
Interval 0.94 to 1.12
|
1.17 Geometric Mean Fold Ratios (GMFRs)
Interval 1.05 to 1.32
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgG Day 28
|
8.91 Geometric Mean Fold Ratios (GMFRs)
Interval 7.35 to 10.81
|
11.39 Geometric Mean Fold Ratios (GMFRs)
Interval 9.33 to 13.9
|
1.31 Geometric Mean Fold Ratios (GMFRs)
Interval 1.08 to 1.58
|
1.22 Geometric Mean Fold Ratios (GMFRs)
Interval 1.08 to 1.37
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgG Day 35
|
10.90 Geometric Mean Fold Ratios (GMFRs)
Interval 8.94 to 13.29
|
14.26 Geometric Mean Fold Ratios (GMFRs)
Interval 11.74 to 17.31
|
1.32 Geometric Mean Fold Ratios (GMFRs)
Interval 1.13 to 1.53
|
1.22 Geometric Mean Fold Ratios (GMFRs)
Interval 1.08 to 1.38
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgG Day 42
|
11.72 Geometric Mean Fold Ratios (GMFRs)
Interval 9.67 to 14.21
|
13.65 Geometric Mean Fold Ratios (GMFRs)
Interval 11.33 to 16.44
|
1.36 Geometric Mean Fold Ratios (GMFRs)
Interval 1.11 to 1.66
|
1.24 Geometric Mean Fold Ratios (GMFRs)
Interval 1.09 to 1.41
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgG Day 56
|
11.34 Geometric Mean Fold Ratios (GMFRs)
Interval 9.4 to 13.68
|
13.47 Geometric Mean Fold Ratios (GMFRs)
Interval 11.26 to 16.1
|
1.36 Geometric Mean Fold Ratios (GMFRs)
Interval 1.15 to 1.6
|
1.19 Geometric Mean Fold Ratios (GMFRs)
Interval 1.05 to 1.36
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgG Day 90
|
11.18 Geometric Mean Fold Ratios (GMFRs)
Interval 9.38 to 13.32
|
11.04 Geometric Mean Fold Ratios (GMFRs)
Interval 9.28 to 13.15
|
1.23 Geometric Mean Fold Ratios (GMFRs)
Interval 1.12 to 1.36
|
1.36 Geometric Mean Fold Ratios (GMFRs)
Interval 1.2 to 1.54
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgG Day 180
|
6.49 Geometric Mean Fold Ratios (GMFRs)
Interval 5.41 to 7.79
|
6.58 Geometric Mean Fold Ratios (GMFRs)
Interval 5.58 to 7.76
|
1.15 Geometric Mean Fold Ratios (GMFRs)
Interval 1.01 to 1.3
|
1.23 Geometric Mean Fold Ratios (GMFRs)
Interval 1.09 to 1.4
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgA Day 7
|
1.02 Geometric Mean Fold Ratios (GMFRs)
Interval 0.96 to 1.08
|
0.98 Geometric Mean Fold Ratios (GMFRs)
Interval 0.93 to 1.04
|
1.00 Geometric Mean Fold Ratios (GMFRs)
Interval 0.93 to 1.06
|
1.02 Geometric Mean Fold Ratios (GMFRs)
Interval 0.97 to 1.08
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgA Day 14
|
1.81 Geometric Mean Fold Ratios (GMFRs)
Interval 1.59 to 2.07
|
1.99 Geometric Mean Fold Ratios (GMFRs)
Interval 1.69 to 2.34
|
0.95 Geometric Mean Fold Ratios (GMFRs)
Interval 0.88 to 1.02
|
1.00 Geometric Mean Fold Ratios (GMFRs)
Interval 0.94 to 1.07
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgA Day 21
|
2.52 Geometric Mean Fold Ratios (GMFRs)
Interval 2.17 to 2.93
|
2.61 Geometric Mean Fold Ratios (GMFRs)
Interval 2.2 to 3.1
|
1.04 Geometric Mean Fold Ratios (GMFRs)
Interval 0.92 to 1.19
|
1.01 Geometric Mean Fold Ratios (GMFRs)
Interval 0.93 to 1.08
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgA Day 28
|
4.03 Geometric Mean Fold Ratios (GMFRs)
Interval 3.49 to 4.65
|
4.38 Geometric Mean Fold Ratios (GMFRs)
Interval 3.72 to 5.17
|
1.07 Geometric Mean Fold Ratios (GMFRs)
Interval 0.96 to 1.2
|
1.09 Geometric Mean Fold Ratios (GMFRs)
Interval 1.0 to 1.2
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgA Day 35
|
3.91 Geometric Mean Fold Ratios (GMFRs)
Interval 3.41 to 4.48
|
4.28 Geometric Mean Fold Ratios (GMFRs)
Interval 3.63 to 5.04
|
1.11 Geometric Mean Fold Ratios (GMFRs)
Interval 0.99 to 1.24
|
1.08 Geometric Mean Fold Ratios (GMFRs)
Interval 0.98 to 1.18
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgA Day 42
|
3.41 Geometric Mean Fold Ratios (GMFRs)
Interval 2.96 to 3.92
|
3.92 Geometric Mean Fold Ratios (GMFRs)
Interval 3.34 to 4.61
|
1.07 Geometric Mean Fold Ratios (GMFRs)
Interval 0.97 to 1.19
|
1.04 Geometric Mean Fold Ratios (GMFRs)
Interval 0.93 to 1.15
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgA Day 56
|
3.16 Geometric Mean Fold Ratios (GMFRs)
Interval 2.76 to 3.62
|
3.53 Geometric Mean Fold Ratios (GMFRs)
Interval 3.03 to 4.11
|
1.13 Geometric Mean Fold Ratios (GMFRs)
Interval 1.01 to 1.27
|
1.13 Geometric Mean Fold Ratios (GMFRs)
Interval 1.01 to 1.27
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgA Day 90
|
2.32 Geometric Mean Fold Ratios (GMFRs)
Interval 2.03 to 2.65
|
2.58 Geometric Mean Fold Ratios (GMFRs)
Interval 2.22 to 3.0
|
0.98 Geometric Mean Fold Ratios (GMFRs)
Interval 0.92 to 1.06
|
1.02 Geometric Mean Fold Ratios (GMFRs)
Interval 0.92 to 1.12
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios
LT IgA Day 180
|
1.66 Geometric Mean Fold Ratios (GMFRs)
Interval 1.46 to 1.89
|
1.89 Geometric Mean Fold Ratios (GMFRs)
Interval 1.65 to 2.16
|
0.92 Geometric Mean Fold Ratios (GMFRs)
Interval 0.83 to 1.03
|
0.90 Geometric Mean Fold Ratios (GMFRs)
Interval 0.8 to 1.0
|
SECONDARY outcome
Timeframe: Day 0 to Day 180Population: the numbers analyzed differs from the Overall number analyzed because for this the Immunogenicity Evaluable Population (IEP) was used: includes all study subjects that were consented, randomized, received the assigned Treatments (both vaccinations) without significant protocol deviations and had blood drawn on Day 0, Day 21 and Day 35
LT immunoglobulin G (IgG) and immunoglobulin A (IgA)
Outcome measures
| Measure |
Group 1 & 2 Combined: 37.5µg LT Patch
n=182 Participants
with or without swabbing
|
Group 3 & 4 Combined: Placebo Patch (0µg LT)
n=173 Participants
with or without swabbing
|
Placebo Patch Without Swabbing
n=92 Participants
Two vaccination (Day 0 and Day 14) regimen with a placebo patch (no swabbing)
Placebo: Travelers' Diarrhea Vaccine System
|
Placebo Patch With Swabbing
n=90 Participants
Two vaccination (Day 0 and Day 14) regimen with a placebo patch (with swabbing)
SPS:Buffer-prepared site swabbed with a 70% isopropyl alcohol pad
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|---|---|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgG Day 7
|
7.18 percentage of participants
Interval 3.88 to 11.97
|
7.56 percentage of participants
Interval 4.09 to 12.58
|
3.33 percentage of participants
Interval 0.69 to 9.43
|
6.74 percentage of participants
Interval 2.51 to 14.1
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgG Day 14
|
47.51 percentage of participants
Interval 40.06 to 55.05
|
49.42 percentage of participants
Interval 41.72 to 57.13
|
2.17 percentage of participants
Interval 0.26 to 7.63
|
3.33 percentage of participants
Interval 0.69 to 9.43
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgG Day 21
|
67.03 percentage of participants
Interval 59.69 to 73.81
|
74.57 percentage of participants
Interval 67.4 to 80.87
|
5.43 percentage of participants
Interval 1.79 to 12.23
|
16.67 percentage of participants
Interval 9.64 to 26.0
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgG Day 28
|
86.67 percentage of participants
Interval 80.81 to 91.27
|
89.53 percentage of participants
Interval 83.97 to 93.68
|
14.13 percentage of participants
Interval 7.74 to 22.95
|
16.67 percentage of participants
Interval 9.64 to 26.0
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgG Day 35
|
90.11 percentage of participants
Interval 84.82 to 94.03
|
93.06 percentage of participants
Interval 88.2 to 96.36
|
15.22 percentage of participants
Interval 8.58 to 24.21
|
17.78 percentage of participants
Interval 10.52 to 27.26
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgG Day 42
|
90.61 percentage of participants
Interval 85.39 to 94.43
|
94.71 percentage of participants
Interval 90.19 to 97.55
|
17.78 percentage of participants
Interval 10.52 to 27.26
|
20.00 percentage of participants
Interval 12.31 to 29.75
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgG Day 56
|
92.09 percentage of participants
Interval 87.09 to 95.61
|
95.81 percentage of participants
Interval 91.55 to 98.3
|
16.67 percentage of participants
Interval 9.64 to 26.0
|
16.67 percentage of participants
Interval 9.64 to 26.0
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgG Day 90
|
93.49 percentage of participants
Interval 88.65 to 96.71
|
93.79 percentage of participants
Interval 88.87 to 96.98
|
11.24 percentage of participants
Interval 5.52 to 19.69
|
24.72 percentage of participants
Interval 16.19 to 35.0
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgG Day 180
|
85.09 percentage of participants
Interval 78.64 to 90.21
|
90.26 percentage of participants
Interval 84.44 to 94.45
|
9.41 percentage of participants
Interval 4.15 to 17.71
|
20.93 percentage of participants
Interval 12.9 to 31.05
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgA Day 7
|
1.66 percentage of participants
Interval 0.34 to 4.77
|
1.74 percentage of participants
Interval 0.36 to 5.01
|
0.00 percentage of participants
Interval 0.0 to 4.02
|
0.00 percentage of participants
Interval 0.0 to 4.06
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgA Day 14
|
17.68 percentage of participants
Interval 12.42 to 24.03
|
23.84 percentage of participants
Interval 17.68 to 30.92
|
0.00 percentage of participants
Interval 0.0 to 3.93
|
1.11 percentage of participants
Interval 0.03 to 6.04
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgA Day 21
|
32.42 percentage of participants
Interval 25.68 to 39.74
|
36.42 percentage of participants
Interval 29.25 to 44.06
|
1.09 percentage of participants
Interval 0.03 to 5.91
|
1.11 percentage of participants
Interval 0.03 to 6.04
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgA Day 28
|
50.56 percentage of participants
Interval 43.02 to 58.07
|
54.65 percentage of participants
Interval 46.9 to 62.24
|
2.17 percentage of participants
Interval 0.26 to 7.63
|
2.22 percentage of participants
Interval 0.27 to 7.8
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgA Day 35
|
51.10 percentage of participants
Interval 43.6 to 58.57
|
54.91 percentage of participants
Interval 47.18 to 62.48
|
2.17 percentage of participants
Interval 0.26 to 7.63
|
2.22 percentage of participants
Interval 0.27 to 7.8
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgA Day 42
|
46.96 percentage of participants
Interval 39.52 to 54.51
|
51.76 percentage of participants
Interval 43.99 to 59.48
|
1.11 percentage of participants
Interval 0.03 to 6.04
|
2.22 percentage of participants
Interval 0.27 to 7.8
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgA Day 56
|
40.68 percentage of participants
Interval 33.37 to 48.3
|
49.70 percentage of participants
Interval 41.88 to 57.53
|
3.33 percentage of participants
Interval 0.69 to 9.43
|
3.33 percentage of participants
Interval 0.69 to 9.43
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgA Day 90
|
26.63 percentage of participants
Interval 20.13 to 33.96
|
37.27 percentage of participants
Interval 29.79 to 45.23
|
0.00 percentage of participants
Interval 0.0 to 4.06
|
1.12 percentage of participants
Interval 0.03 to 6.1
|
|
Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates
LT IgA Day 180
|
14.91 percentage of participants
Interval 9.79 to 21.36
|
17.53 percentage of participants
Interval 11.88 to 24.47
|
1.18 percentage of participants
Interval 0.03 to 6.38
|
0.00 percentage of participants
Interval 0.0 to 4.2
|
Adverse Events
Group 1: 37.5μg LT, No Swab
Serious events: 1 serious events
Other events: 197 other events
Deaths: 0 deaths
Group 2: 37.5μg LT, Swab
Serious events: 3 serious events
Other events: 192 other events
Deaths: 0 deaths
Group 3: 0μg LT, No Swab
Serious events: 0 serious events
Other events: 90 other events
Deaths: 0 deaths
Group 4: 0μg LT, Swab
Serious events: 0 serious events
Other events: 92 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: 37.5μg LT, No Swab
n=203 participants at risk
Two vaccination regimen with an LT patch (no swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 37.5μg LT, Swab
n=199 participants at risk
Two vaccination regimen with an LT patch (with swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 3: 0μg LT, No Swab
n=97 participants at risk
Two vaccination regimen with a placebo patch (no swabbing)
Placebo: Travelers' Diarrhea Vaccine System
|
Group 4: 0μg LT, Swab
n=101 participants at risk
Two vaccination regimen with a placebo patch (with swabbing)
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.49%
1/203
|
0.00%
0/199
|
0.00%
0/97
|
0.00%
0/101
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/203
|
0.50%
1/199
|
0.00%
0/97
|
0.00%
0/101
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/203
|
0.50%
1/199
|
0.00%
0/97
|
0.00%
0/101
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/203
|
0.50%
1/199
|
0.00%
0/97
|
0.00%
0/101
|
Other adverse events
| Measure |
Group 1: 37.5μg LT, No Swab
n=203 participants at risk
Two vaccination regimen with an LT patch (no swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 2: 37.5μg LT, Swab
n=199 participants at risk
Two vaccination regimen with an LT patch (with swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
|
Group 3: 0μg LT, No Swab
n=97 participants at risk
Two vaccination regimen with a placebo patch (no swabbing)
Placebo: Travelers' Diarrhea Vaccine System
|
Group 4: 0μg LT, Swab
n=101 participants at risk
Two vaccination regimen with a placebo patch (with swabbing)
Placebo: Travelers' Diarrhea Vaccine System
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
16.3%
33/203
|
18.1%
36/199
|
19.6%
19/97
|
17.8%
18/101
|
|
General disorders
Malaise
|
8.9%
18/203
|
12.6%
25/199
|
9.3%
9/97
|
5.9%
6/101
|
|
Gastrointestinal disorders
Diarrhea
|
16.3%
33/203
|
20.1%
40/199
|
14.4%
14/97
|
13.9%
14/101
|
|
General disorders
Vaccination site erythema
|
80.8%
164/203
|
78.9%
157/199
|
45.4%
44/97
|
31.7%
32/101
|
|
General disorders
Vaccination site rash
|
85.2%
173/203
|
84.4%
168/199
|
9.3%
9/97
|
9.9%
10/101
|
|
General disorders
Vaccination site hyperpigmentation
|
68.5%
139/203
|
69.3%
138/199
|
6.2%
6/97
|
5.9%
6/101
|
|
General disorders
Vaccination site edema
|
27.6%
56/203
|
36.7%
73/199
|
2.1%
2/97
|
0.99%
1/101
|
|
General disorders
Vaccination site pain
|
19.7%
40/203
|
23.6%
47/199
|
10.3%
10/97
|
12.9%
13/101
|
|
General disorders
Vaccination site pruritis
|
80.3%
163/203
|
78.4%
156/199
|
22.7%
22/97
|
14.9%
15/101
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER