Prevention of Travelers' Diarrhea
Conditions
Brief summary
To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.
Interventions
BIOLOGICALheat-labile enterotoxin of E. coli (LT)
Travelers' Diarrhea Vaccine System
BIOLOGICALPlacebo
Travelers' Diarrhea Vaccine System
Sponsors
Intercell USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult males or females, 18-64 years of age (inclusive) at the planned start of the study (first vaccination on Day 0) * Signed Informed Consent * Women who are not post-menopausal or surgically sterile must have a negative serum/urine pregnancy test at screening and within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant and to employ an effective form of birth control for the duration of the study. Acceptable forms of birth control are: abstinence, hormonal contraceptives (oral, injectable, implant, patch, ring), double-barrier contraceptives (condom or diaphragm, with spermicide), and IUD.
Exclusion criteria
* Laboratory abnormalities \[as determined by the Toxicity Grading Scale (grade 1 4)\] at laboratory screening * Abnormalities at physical examination \[as determined by the Toxicity Grading Scale (grade 1-4)\] * Known allergies to any component of the vaccine * Known allergies to adhesives * Participated in research involving investigational product within 30 days before planned date of first vaccination or within 90 days after first vaccination * Donated blood or blood products such as plasma within 30 days prior to planned date of first vaccination or within 90 days after first vaccination * Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd * Ever received cholera toxin or vaccine (e.g. Orochol™, Dukoral™) * History of diarrhea while traveling in a developing country within the last year * History of abdominal surgery (excluding C-section, hysterectomy, cosmetic surgery, liposuction, appendectomy, cholecystectomy, ventral hernia repair, and other surgeries not pertaining to gastrointestinal problems) or history of, or recent acute gastrointestinal illness * Positive serology for HIV-1, HIV-2, HBsAg, or HCV * Medical history of acute or chronic skin disease at vaccination area(s) * Active skin allergy * Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation * Excessively hirsute and unwilling to clip hair at the vaccination area(s) * Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s) * Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination * Women who are pregnant or breastfeeding * Acute illness at screening and unresolved at time of planned vaccination * Employee of the investigational site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194 | — |
| Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | Day 14, Day 21, Day 28, Day 35, Day 90, Day 194 | GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data. |
| Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | Day 14, Day 21, Day 28, Day 35, Day 90, Day 194 | Definition of SCR: * Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline * Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | 13 months | LT subjects (Group 1) were followed for six months longer (until Day 380) than Placebo subjects (Group 2) (until Day 194) |
| Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group | 13 months | GMFR |
| Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear | 1 month | — |
| Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group | 13 months | GMT |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: 37.5 µg LT Patch heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System | 81 |
| Group 2: 0 µg LT Patch (Placebo) Placebo: Travelers' Diarrhea Vaccine System | 39 |
| Total | 120 |
Baseline characteristics
| Characteristic | Group 1: 37.5 µg LT Patch | Group 2: 0 µg LT Patch (Placebo) | Total |
|---|---|---|---|
| Age, Continuous | 34.1 years STANDARD_DEVIATION 10.2 | 35.3 years STANDARD_DEVIATION 13 | 34.5 years STANDARD_DEVIATION 11.2 |
| Sex: Female, Male Female | 46 Participants | 26 Participants | 72 Participants |
| Sex: Female, Male Male | 35 Participants | 13 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 79 / 81 | 32 / 39 |
| serious Total, serious adverse events | 1 / 81 | 2 / 39 |
Outcome results
Primary
Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.
Time frame: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Population: Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: 37.5 µg LT Patch | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgG - Day 21 | 21.1 ratio |
| Group 1: 37.5 µg LT Patch | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgG - Day 14 | 10.4 ratio |
| Group 1: 37.5 µg LT Patch | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgG - Day 28 | 31.0 ratio |
| Group 1: 37.5 µg LT Patch | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgG - Day 35 | 34.7 ratio |
| Group 1: 37.5 µg LT Patch | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgG - Day 90 | 16.0 ratio |
| Group 1: 37.5 µg LT Patch | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgG - Day 194 | 5.7 ratio |
| Group 1: 37.5 µg LT Patch | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgA - Day 14 | 8.0 ratio |
| Group 1: 37.5 µg LT Patch | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgA - Day 21 | 12.5 ratio |
| Group 1: 37.5 µg LT Patch | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgA - Day 28 | 15.8 ratio |
| Group 1: 37.5 µg LT Patch | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgA - Day 35 | 13.8 ratio |
| Group 1: 37.5 µg LT Patch | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgA - Day 90 | 7.1 ratio |
| Group 1: 37.5 µg LT Patch | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgA - Day 194 | 3.4 ratio |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgA - Day 90 | 0.6 ratio |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgG - Day 21 | 1.2 ratio |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgA - Day 14 | 1.0 ratio |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgG - Day 14 | 1.2 ratio |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgA - Day 35 | 0.9 ratio |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgG - Day 28 | 0.9 ratio |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgA - Day 21 | 1.0 ratio |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgG - Day 35 | 1.0 ratio |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgA - Day 194 | 0.5 ratio |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgG - Day 90 | 0.4 ratio |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgA - Day 28 | 0.9 ratio |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMFR LT IgG - Day 194 | 0.2 ratio |
Primary
Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
Time frame: Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Population: Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 0 | 432.6 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 14 | 4477.5 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 21 | 9107.7 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 28 | 13411.9 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 35 | 15024.3 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 90 | 6823.7 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 194 | 2489.2 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 0 | 49.4 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 14 | 395.6 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 21 | 619.2 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 28 | 780.0 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 35 | 681.2 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 90 | 348.1 geometric mean titer |
| Group 1: 37.5 µg LT Patch | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 194 | 177.0 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 28 | 53.9 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 0 | 400.5 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 0 | 58.9 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 14 | 490.6 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 90 | 40.5 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 21 | 462.1 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 14 | 59.1 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 28 | 372.6 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 35 | 52.5 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 35 | 383.6 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 21 | 60.9 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 90 | 156.2 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgA - Day 194 | 32.6 geometric mean titer |
| Group 2: 0 µg LT Patch (Placebo) | Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | GMT LT IgG - Day 194 | 100.2 geometric mean titer |
Primary
Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
Definition of SCR: * Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline * Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline
Time frame: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194
Population: Immunogenicity Evaluable Population (IEP): all study subjects who are consented, randomized, received the assigned treatments (both vaccinations), and had blood drawn for immunogenicity testing at baseline (Day 0) and both of the following time points: Day 21 and Day 35.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: 37.5 µg LT Patch | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgG - Day 21 | 89.5 percentage of participants |
| Group 1: 37.5 µg LT Patch | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgA - Day 14 | 57.9 percentage of participants |
| Group 1: 37.5 µg LT Patch | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgG - Day 35 | 97.4 percentage of participants |
| Group 1: 37.5 µg LT Patch | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgA - Day 21 | 71.1 percentage of participants |
| Group 1: 37.5 µg LT Patch | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgG - Day 14 | 77.6 percentage of participants |
| Group 1: 37.5 µg LT Patch | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgA - Day 28 | 82.9 percentage of participants |
| Group 1: 37.5 µg LT Patch | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgG - Day 90 | 98.7 percentage of participants |
| Group 1: 37.5 µg LT Patch | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgA - Day 35 | 81.6 percentage of participants |
| Group 1: 37.5 µg LT Patch | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgG - Day 28 | 97.4 percentage of participants |
| Group 1: 37.5 µg LT Patch | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgA - Day 90 | 68.0 percentage of participants |
| Group 1: 37.5 µg LT Patch | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgA - Day 194 | 50.0 percentage of participants |
| Group 1: 37.5 µg LT Patch | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgG - Day 194 | 83.3 percentage of participants |
| Group 2: 0 µg LT Patch (Placebo) | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgA - Day 194 | 0.0 percentage of participants |
| Group 2: 0 µg LT Patch (Placebo) | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgG - Day 14 | 8.8 percentage of participants |
| Group 2: 0 µg LT Patch (Placebo) | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgG - Day 21 | 8.8 percentage of participants |
| Group 2: 0 µg LT Patch (Placebo) | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgG - Day 28 | 2.9 percentage of participants |
| Group 2: 0 µg LT Patch (Placebo) | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgG - Day 35 | 5.9 percentage of participants |
| Group 2: 0 µg LT Patch (Placebo) | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgG - Day 90 | 9.1 percentage of participants |
| Group 2: 0 µg LT Patch (Placebo) | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgG - Day 194 | 0 percentage of participants |
| Group 2: 0 µg LT Patch (Placebo) | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgA - Day 14 | 0.0 percentage of participants |
| Group 2: 0 µg LT Patch (Placebo) | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgA - Day 21 | 0.0 percentage of participants |
| Group 2: 0 µg LT Patch (Placebo) | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgA - Day 28 | 0.0 percentage of participants |
| Group 2: 0 µg LT Patch (Placebo) | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgA - Day 35 | 2.9 percentage of participants |
| Group 2: 0 µg LT Patch (Placebo) | Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo | SCR LT IgA - Day 90 | 3.0 percentage of participants |
Secondary
Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group
GMT
Time frame: 13 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: 37.5 µg LT Patch | Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group | GMT LT IgG - Day 380 | 1653.7 GMT |
| Group 1: 37.5 µg LT Patch | Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group | GMT LT IgA - Day 380 | 122.3 GMT |
Secondary
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
SCR
Time frame: 13 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: 37.5 µg LT Patch | Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group | SCR LT IgG - Day 380 | 67.1 percentage of participants |
| Group 1: 37.5 µg LT Patch | Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group | SCR LT IgA - Day 380 | 38.6 percentage of participants |
Secondary
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
GMFR
Time frame: 13 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: 37.5 µg LT Patch | Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group | GMFR LT IgG - Day 380 | 3.8 ratio |
| Group 1: 37.5 µg LT Patch | Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group | GMFR LT IgA - Day 380 | 2.4 ratio |
Secondary
Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear
Time frame: 1 month
Population: Summary statistics are only shown for the LT Group in a protocol pre-defined subset of subjects, results for the Placebo Group were below the Limit of detection in all cases
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: 37.5 µg LT Patch | Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear | Residual LT in the Patch (ng LT) | 15893 nanograms (ng) | Standard Deviation 6980 |
| Group 1: 37.5 µg LT Patch | Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear | Residual LT in the Swab (ng LT) | 7231 nanograms (ng) | Standard Deviation 2939 |
| Group 1: 37.5 µg LT Patch | Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear | Estimate of LT Delivered (ng LT) | 14376 nanograms (ng) | Standard Deviation 7609 |
Secondary
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
LT subjects (Group 1) were followed for six months longer (until Day 380) than Placebo subjects (Group 2) (until Day 194)
Time frame: 13 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs requiring Treatment : Systemic AEs - vacc. 1 | 16 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Severe AEs : Local AEs - vaccination 1 | 0 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs requiring Treatment : Local AEs - vacc. 2 | 4 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs : All AEs - vaccination 2 | 76 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs requiring Treatment : Systemic AEs - vacc. 2 | 31 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Severe AEs : Systemic AEs - vaccination 1 | 2 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | related AEs : All AEs - vaccination 1 | 74 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs : Systemic AEs - vaccination 2 | 44 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | related AEs : All AEs - vaccination 2 | 74 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Severe AEs : Local AEs - vaccination 2 | 0 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | related AEs : Local AEs - vaccination 1 | 73 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs : Systemic AEs - vaccination 1 | 43 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | related AEs : Systemic AEs - vaccination 1 | 17 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Severe AEs : Systemic AEs - vaccination 2 | 2 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | related AEs : Local AEs - vaccination 2 | 73 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Severe AEs : All AEs - vaccination 1 | 2 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | related AEs : Systemic AEs - vaccination 2 | 6 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs requiring Treatment : All AEs - vaccination 1 | 24 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Serious AEs : All AEs - vaccination 1 | 0 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs : Local AEs - vaccination 1 | 73 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Serious AEs : All AEs - vaccination 2 | 1 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs requiring Treatment : All AEs - vaccination 2 | 33 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Serious AEs : Local AEs - vaccination 1 | 0 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Severe AEs : All AEs - vaccination 2 | 2 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Serious AEs : Systemic AEs - vaccination 1 | 0 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs requiring Treatment : Local AEs - vacc. 1 | 10 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Serious AEs : Local AEs - vaccination 2 | 0 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs : Local AEs - vaccination 2 | 73 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Serious AEs : Systemic AEs - vaccination 2 | 1 Participants |
| Group 1: 37.5 µg LT Patch | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs : All AEs - vaccination 1 | 75 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Serious AEs : Systemic AEs - vaccination 2 | 1 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs : All AEs - vaccination 1 | 26 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs : All AEs - vaccination 2 | 24 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs : Local AEs - vaccination 1 | 19 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs : Systemic AEs - vaccination 1 | 18 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs : Local AEs - vaccination 2 | 13 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs : Systemic AEs - vaccination 2 | 18 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Severe AEs : All AEs - vaccination 1 | 2 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Severe AEs : All AEs - vaccination 2 | 0 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Severe AEs : Local AEs - vaccination 1 | 0 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Severe AEs : Systemic AEs - vaccination 1 | 2 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Severe AEs : Local AEs - vaccination 2 | 0 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Severe AEs : Systemic AEs - vaccination 2 | 0 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs requiring Treatment : All AEs - vaccination 1 | 6 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs requiring Treatment : All AEs - vaccination 2 | 10 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs requiring Treatment : Local AEs - vacc. 1 | 0 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs requiring Treatment : Systemic AEs - vacc. 1 | 6 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs requiring Treatment : Local AEs - vacc. 2 | 0 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | AEs requiring Treatment : Systemic AEs - vacc. 2 | 10 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | related AEs : All AEs - vaccination 1 | 20 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | related AEs : All AEs - vaccination 2 | 13 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | related AEs : Local AEs - vaccination 1 | 19 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | related AEs : Systemic AEs - vaccination 1 | 5 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | related AEs : Local AEs - vaccination 2 | 13 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | related AEs : Systemic AEs - vaccination 2 | 3 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Serious AEs : All AEs - vaccination 1 | 1 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Serious AEs : All AEs - vaccination 2 | 1 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Serious AEs : Local AEs - vaccination 1 | 0 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Serious AEs : Systemic AEs - vaccination 1 | 1 Participants |
| Group 2: 0 µg LT Patch (Placebo) | Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch | Serious AEs : Local AEs - vaccination 2 | 0 Participants |