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The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Two vaccination regimen with an LT patch (no swabbing) |
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| 2 | Experimental | Two vaccination regimen with an LT patch (with swabbing) |
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| 3 | Placebo Comparator | Two vaccination regimen with a placebo patch (no swabbing) |
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| 4 | Placebo Comparator | Two vaccination regimen with a placebo patch (with swabbing) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat-Labile Enterotoxin of E. coli (LT) | Biological | Travelers' Diarrhea Vaccine System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Day 0 to Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | LT immunoglobulin G (IgG) and immunoglobulin A (IgA) | Day 0 to Day 180 |
| Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Sheldon, MD | Miami Research Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Clinical Research Institute | Anaheim | California | 92801 | United States | ||
| Miami Research Associates |
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| Label | URL |
|---|---|
| Intercell Home Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Group 3: 0μg LT, No Swab | Two vaccination regimen with a placebo patch (no swabbing) Placebo: Travelers' Diarrhea Vaccine System |
| FG003 | Group 4: 0μg LT, Swab | Two vaccination regimen with a placebo patch (with swabbing) Placebo: Travelers' Diarrhea Vaccine System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Up to Day 180 |
| |||||||||||||
| 180 to Day 720 |
|
safety population: includes all study subjects that were consented and received investigational study material (i.e., at least one vaccination)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Group 2: 37.5μg LT, Swab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Number | participants | Day 0 to Day 180 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head Clinical Developement | Valneva Austria GmbH | 0043120620 | 0 | info@valneva.com |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Biological | Travelers' Diarrhea Vaccine System |
|
LT immunoglobulin G (IgG) and immunoglobulin A (IgA) |
| Day 0 to Day 180 |
| Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT immunoglobulin G (IgG) and immunoglobulin A (IgA) | Day 0 to Day 180 |
| South Miami |
| Florida |
| 33143 |
| United States |
| Johnson County Clinical Trials | Lenexa | Kansas | 66219 | United States |
| Radiant Research | Cincinnati | Ohio | 45249 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Two vaccination regimen with an LT patch (with swabbing)
Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
| BG002 | Group 3: 0μg LT, No Swab | Two vaccination regimen with a placebo patch (no swabbing) Placebo: Travelers' Diarrhea Vaccine System |
| BG003 | Group 4: 0μg LT, Swab | Two vaccination regimen with a placebo patch (with swabbing) Placebo: Travelers' Diarrhea Vaccine System |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers | LT immunoglobulin G (IgG) and immunoglobulin A (IgA) | 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 | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 0 to Day 180 |
|
|
|
| Secondary | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios | LT immunoglobulin G (IgG) and immunoglobulin A (IgA) | 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 | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Fold Ratios (GMFRs) | Day 0 to Day 180 |
|
|
|
| Secondary | Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates | LT immunoglobulin G (IgG) and immunoglobulin A (IgA) | 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 | Posted | Geometric Mean | 95% Confidence Interval | percentage of participants | Day 0 to Day 180 |
|
|
|
| 1 |
| 203 |
| 197 |
| 203 |
| EG001 | 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 | 3 | 199 | 192 | 199 |
| EG002 | Group 3: 0μg LT, No Swab | Two vaccination regimen with a placebo patch (no swabbing) Placebo: Travelers' Diarrhea Vaccine System | 0 | 97 | 90 | 97 |
| EG003 | Group 4: 0μg LT, Swab | Two vaccination regimen with a placebo patch (with swabbing) Placebo: Travelers' Diarrhea Vaccine System | 0 | 101 | 92 | 101 |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions |
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| Bipolar disorder | Psychiatric disorders |
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| Accelerated hypertension | Vascular disorders |
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| Malaise | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Vaccination site erythema | General disorders | Systematic Assessment |
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| Vaccination site rash | General disorders | Systematic Assessment |
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| Vaccination site hyperpigmentation | General disorders | Systematic Assessment |
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| Vaccination site edema | General disorders | Systematic Assessment |
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| Vaccination site pain | General disorders | Systematic Assessment |
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| Vaccination site pruritis | General disorders | Systematic Assessment |
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| IgG Day 7 |
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| IgG Day 14 |
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| IgG Day 21 |
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| IgG Day 28 |
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| IgG Day 35 |
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| IgG Day 42 |
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| IgG Day 56 |
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| IgG Day 90 |
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| IgG Day 180 |
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| IgA Day 0 |
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| IgA Day 7 |
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| IgA Day 14 |
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| IgA Day 21 |
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| IgA Day 28 |
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| IgA Day 35 |
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| IgA Day 42 |
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| IgA Day 56 |
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| IgA Day 90 |
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| IgA Day 180 |
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| LT IgG Day 14 |
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| LT IgG Day 21 |
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| LT IgG Day 28 |
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| LT IgG Day 35 |
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| LT IgG Day 42 |
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| LT IgG Day 56 |
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| LT IgG Day 90 |
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| LT IgG Day 180 |
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| LT IgA Day 7 |
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| LT IgA Day 14 |
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| LT IgA Day 21 |
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| LT IgA Day 28 |
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| LT IgA Day 35 |
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| LT IgA Day 42 |
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| LT IgA Day 56 |
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| LT IgA Day 90 |
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| LT IgA Day 180 |
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| LT IgG Day 14 |
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| LT IgG Day 21 |
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| LT IgG Day 28 |
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| LT IgG Day 35 |
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| LT IgG Day 42 |
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| LT IgG Day 56 |
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| LT IgG Day 90 |
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| LT IgG Day 180 |
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| LT IgA Day 7 |
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| LT IgA Day 14 |
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| LT IgA Day 21 |
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| LT IgA Day 28 |
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| LT IgA Day 35 |
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| LT IgA Day 42 |
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| LT IgA Day 56 |
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| LT IgA Day 90 |
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| LT IgA Day 180 |
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