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Traveler's Diarrhea (TD) Automated Process

Sponsor
Intercell USA, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00751777
Collaborator
(none)
120
Enrollment
3
Locations
2
Arms
14
Duration (Months)
40
Patients Per Site
2.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: heat-labile enterotoxin of E. coli (LT)
  • Biological: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Two Vaccination Regimen With an LT Vaccine Patch in Healthy Adults
Study Start Date :
Sep 1, 2008
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1: 37.5 µg LT patch

80 subjects will receive a two vaccination regimen with a LT patch.

Biological: heat-labile enterotoxin of E. coli (LT)
Travelers' Diarrhea Vaccine System
Other Names:
  • TD Vaccine System

    		•
    Placebo Comparator: Group 2: 0 µg LT patch (placebo)

    40 subjects will receive a two vaccination regimen with a placebo patch.

    Biological: Placebo
    Travelers' Diarrhea Vaccine System
    Other Names:
  • TD Vaccine System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. 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.

    3. 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 Outcome Measures

    1. 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)

    2. Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear [1 month]

    3. Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group [13 months]

      GMT

    4. Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group [13 months]

      GMFR

    5. Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group [13 months]

      SCR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Solano Clinical Research Vallejo California United States 94589
    2 Miami Research Associates South Miami Florida United States 33143
    3 Clinical Trials of Texas San Antonio Texas United States 78229

    Sponsors and Collaborators

    • Intercell USA, Inc.

    Investigators

    • Principal Investigator: Eric Sheldon, MD, Miami Research Associates

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Intercell USA, Inc.
    ClinicalTrials.gov Identifier:
    NCT00751777
    Other Study ID Numbers:
    • ELT207
    First Posted:
    Sep 12, 2008
    Last Update Posted:
    Jan 29, 2020
    Last Verified:
    Jan 1, 2020
    Additional relevant MeSH terms:
    Dysentery
    Diarrhea
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Group 1: 37.5 µg LT Patch Group 2: 0 µg LT Patch (Placebo)
    Arm/Group Description heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System Placebo: Travelers' Diarrhea Vaccine System
    Period Title: Overall Study
    STARTED 81 39
    COMPLETED 70 36
    NOT COMPLETED 11 3

    Baseline Characteristics

    Arm/Group Title Group 1: 37.5 µg LT Patch Group 2: 0 µg LT Patch (Placebo) Total
    Arm/Group Description heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System Placebo: Travelers' Diarrhea Vaccine System Total of all reporting groups
    Overall Participants 81 39 120
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    34.1
    (10.2)
    35.3
    (13.0)
    34.5
    (11.2)
    Sex: Female, Male (Count of Participants)
    Female
    46
    56.8%
    26
    66.7%
    72
    60%
    Male
    35
    43.2%
    13
    33.3%
    48
    40%

    Outcome Measures

    1. Primary Outcome
    Title Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
    Description
    Time Frame Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Group 1: 37.5 µg LT Patch Group 2: 0 µg LT Patch (Placebo)
    Arm/Group Description heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System Placebo: Travelers' Diarrhea Vaccine System
    Measure Participants 76 34
    GMT LT IgG - Day 0
    432.6
    400.5
    GMT LT IgG - Day 14
    4477.5
    490.6
    GMT LT IgG - Day 21
    9107.7
    462.1
    GMT LT IgG - Day 28
    13411.9
    372.6
    GMT LT IgG - Day 35
    15024.3
    383.6
    GMT LT IgG - Day 90
    6823.7
    156.2
    GMT LT IgG - Day 194
    2489.2
    100.2
    GMT LT IgA - Day 0
    49.4
    58.9
    GMT LT IgA - Day 14
    395.6
    59.1
    GMT LT IgA - Day 21
    619.2
    60.9
    GMT LT IgA - Day 28
    780.0
    53.9
    GMT LT IgA - Day 35
    681.2
    52.5
    GMT LT IgA - Day 90
    348.1
    40.5
    GMT LT IgA - Day 194
    177.0
    32.6
    2. Primary Outcome
    Title Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Group 1: 37.5 µg LT Patch Group 2: 0 µg LT Patch (Placebo)
    Arm/Group Description heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System Placebo: Travelers' Diarrhea Vaccine System
    Measure Participants 76 34
    GMFR LT IgG - Day 14
    10.4
    1.2
    GMFR LT IgG - Day 21
    21.1
    1.2
    GMFR LT IgG - Day 28
    31.0
    0.9
    GMFR LT IgG - Day 35
    34.7
    1.0
    GMFR LT IgG - Day 90
    16.0
    0.4
    GMFR LT IgG - Day 194
    5.7
    0.2
    GMFR LT IgA - Day 14
    8.0
    1.0
    GMFR LT IgA - Day 21
    12.5
    1.0
    GMFR LT IgA - Day 28
    15.8
    0.9
    GMFR LT IgA - Day 35
    13.8
    0.9
    GMFR LT IgA - Day 90
    7.1
    0.6
    GMFR LT IgA - Day 194
    3.4
    0.5
    3. Primary Outcome
    Title Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
    Description 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

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Group 1: 37.5 µg LT Patch Group 2: 0 µg LT Patch (Placebo)
    Arm/Group Description heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System Placebo: Travelers' Diarrhea Vaccine System
    Measure Participants 76 34
    SCR LT IgG - Day 14
    77.6
    95.8%
    8.8
    22.6%
    SCR LT IgG - Day 21
    89.5
    110.5%
    8.8
    22.6%
    SCR LT IgG - Day 28
    97.4
    120.2%
    2.9
    7.4%
    SCR LT IgG - Day 35
    97.4
    120.2%
    5.9
    15.1%
    SCR LT IgG - Day 90
    98.7
    121.9%
    9.1
    23.3%
    SCR LT IgG - Day 194
    83.3
    102.8%
    0
    0%
    SCR LT IgA - Day 14
    57.9
    71.5%
    0.0
    0%
    SCR LT IgA - Day 21
    71.1
    87.8%
    0.0
    0%
    SCR LT IgA - Day 28
    82.9
    102.3%
    0.0
    0%
    SCR LT IgA - Day 35
    81.6
    100.7%
    2.9
    7.4%
    SCR LT IgA - Day 90
    68.0
    84%
    3.0
    7.7%
    SCR LT IgA - Day 194
    50.0
    61.7%
    0.0
    0%
    4. Secondary Outcome
    Title Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: 37.5 µg LT Patch Group 2: 0 µg LT Patch (Placebo)
    Arm/Group Description heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System Placebo: Travelers' Diarrhea Vaccine System
    Measure Participants 81 39
    AEs : All AEs - vaccination 1
    75
    92.6%
    26
    66.7%
    AEs : All AEs - vaccination 2
    76
    93.8%
    24
    61.5%
    AEs : Local AEs - vaccination 1
    73
    90.1%
    19
    48.7%
    AEs : Systemic AEs - vaccination 1
    43
    53.1%
    18
    46.2%
    AEs : Local AEs - vaccination 2
    73
    90.1%
    13
    33.3%
    AEs : Systemic AEs - vaccination 2
    44
    54.3%
    18
    46.2%
    Severe AEs : All AEs - vaccination 1
    2
    2.5%
    2
    5.1%
    Severe AEs : All AEs - vaccination 2
    2
    2.5%
    0
    0%
    Severe AEs : Local AEs - vaccination 1
    0
    0%
    0
    0%
    Severe AEs : Systemic AEs - vaccination 1
    2
    2.5%
    2
    5.1%
    Severe AEs : Local AEs - vaccination 2
    0
    0%
    0
    0%
    Severe AEs : Systemic AEs - vaccination 2
    2
    2.5%
    0
    0%
    AEs requiring Treatment : All AEs - vaccination 1
    24
    29.6%
    6
    15.4%
    AEs requiring Treatment : All AEs - vaccination 2
    33
    40.7%
    10
    25.6%
    AEs requiring Treatment : Local AEs - vacc. 1
    10
    12.3%
    0
    0%
    AEs requiring Treatment : Systemic AEs - vacc. 1
    16
    19.8%
    6
    15.4%
    AEs requiring Treatment : Local AEs - vacc. 2
    4
    4.9%
    0
    0%
    AEs requiring Treatment : Systemic AEs - vacc. 2
    31
    38.3%
    10
    25.6%
    related AEs : All AEs - vaccination 1
    74
    91.4%
    20
    51.3%
    related AEs : All AEs - vaccination 2
    74
    91.4%
    13
    33.3%
    related AEs : Local AEs - vaccination 1
    73
    90.1%
    19
    48.7%
    related AEs : Systemic AEs - vaccination 1
    17
    21%
    5
    12.8%
    related AEs : Local AEs - vaccination 2
    73
    90.1%
    13
    33.3%
    related AEs : Systemic AEs - vaccination 2
    6
    7.4%
    3
    7.7%
    Serious AEs : All AEs - vaccination 1
    0
    0%
    1
    2.6%
    Serious AEs : All AEs - vaccination 2
    1
    1.2%
    1
    2.6%
    Serious AEs : Local AEs - vaccination 1
    0
    0%
    0
    0%
    Serious AEs : Systemic AEs - vaccination 1
    0
    0%
    1
    2.6%
    Serious AEs : Local AEs - vaccination 2
    0
    0%
    0
    0%
    Serious AEs : Systemic AEs - vaccination 2
    1
    1.2%
    1
    2.6%
    5. Secondary Outcome
    Title Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear
    Description
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    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/Group Title Group 1: 37.5 µg LT Patch
    Arm/Group Description heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
    Measure Participants 22
    Residual LT in the Patch (ng LT)
    15893
    (6980)
    Residual LT in the Swab (ng LT)
    7231
    (2939)
    Estimate of LT Delivered (ng LT)
    14376
    (7609)
    6. Secondary Outcome
    Title Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group
    Description GMT
    Time Frame 13 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: 37.5 µg LT Patch
    Arm/Group Description heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
    Measure Participants 76
    GMT LT IgG - Day 380
    1653.7
    GMT LT IgA - Day 380
    122.3
    7. Secondary Outcome
    Title Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
    Description GMFR
    Time Frame 13 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: 37.5 µg LT Patch
    Arm/Group Description heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
    Measure Participants 76
    GMFR LT IgG - Day 380
    3.8
    GMFR LT IgA - Day 380
    2.4
    8. Secondary Outcome
    Title Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
    Description SCR
    Time Frame 13 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Group 1: 37.5 µg LT Patch
    Arm/Group Description heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System
    Measure Participants 76
    SCR LT IgG - Day 380
    67.1
    82.8%
    SCR LT IgA - Day 380
    38.6
    47.7%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Group 1: 37.5 µg LT Patch Group 2: 0 µg LT Patch (Placebo)
    Arm/Group Description heat-labile enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System Placebo: Travelers' Diarrhea Vaccine System
    All Cause Mortality
    Group 1: 37.5 µg LT Patch Group 2: 0 µg LT Patch (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Group 1: 37.5 µg LT Patch Group 2: 0 µg LT Patch (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/81 (1.2%) 2/39 (5.1%)
    Gastrointestinal disorders
    Haemorrhoidal haemorrhage 0/81 (0%) 1/39 (2.6%)
    General disorders
    Non-cardiac chest pain 1/81 (1.2%) 0/39 (0%)
    Infections and infestations
    Gastroenteritis 0/81 (0%) 1/39 (2.6%)
    Other (Not Including Serious) Adverse Events
    Group 1: 37.5 µg LT Patch Group 2: 0 µg LT Patch (Placebo)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 79/81 (97.5%) 32/39 (82.1%)
    Gastrointestinal disorders
    Diarrhoea 11/81 (13.6%) 4/39 (10.3%)
    General disorders
    Malaise 5/81 (6.2%) 0/39 (0%)
    Infections and infestations
    Upper respiratory tract infection 7/81 (8.6%) 4/39 (10.3%)
    Injury, poisoning and procedural complications
    Application site discolouration 62/81 (76.5%) 5/39 (12.8%)
    Application site erythema 72/81 (88.9%) 14/39 (35.9%)
    Application site oedema 11/81 (13.6%) 0/39 (0%)
    Application site pain 22/81 (27.2%) 3/39 (7.7%)
    Application site pruritus 72/81 (88.9%) 8/39 (20.5%)
    Application site rash 77/81 (95.1%) 5/39 (12.8%)
    Investigations
    Blood glucose increased 6/81 (7.4%) 3/39 (7.7%)
    Haemoglobin decreased 3/81 (3.7%) 2/39 (5.1%)
    Protein urine present 4/81 (4.9%) 3/39 (7.7%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Head Clinical Development
    Organization Valneva Austria GmbH
    Phone 0043120620 ext 0
    Email info@valneva.com
    Responsible Party:
    Intercell USA, Inc.
    ClinicalTrials.gov Identifier:
    NCT00751777
    Other Study ID Numbers:
    • ELT207
    First Posted:
    Sep 12, 2008
    Last Update Posted:
    Jan 29, 2020
    Last Verified:
    Jan 1, 2020