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Traveler's Diarrhea (TD) Automated Process

Primary Purpose

Prevention of Travelers' Diarrhea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
heat-labile enterotoxin of E. coli (LT)
Placebo
Sponsored by
Intercell USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Travelers' Diarrhea

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Solano Clinical Research
  • Miami Research Associates
  • Clinical Trials of Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1: 37.5 µg LT patch

Group 2: 0 µg LT patch (placebo)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo
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.
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

Secondary Outcome Measures

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)
Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear
Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group
GMT
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
GMFR
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
SCR

Full Information

First Posted
September 11, 2008
Last Updated
January 16, 2020
Sponsor
Intercell USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00751777
Brief Title
Traveler's Diarrhea (TD) Automated Process
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 Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intercell USA, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Travelers' Diarrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: 37.5 µg LT patch
Arm Type
Experimental
Arm Description
80 subjects will receive a two vaccination regimen with a LT patch.
Arm Title
Group 2: 0 µg LT patch (placebo)
Arm Type
Placebo Comparator
Arm Description
40 subjects will receive a two vaccination regimen with a placebo patch.
Intervention Type
Biological
Intervention Name(s)
heat-labile enterotoxin of E. coli (LT)
Other Intervention Name(s)
TD Vaccine System
Intervention Description
Travelers' Diarrhea Vaccine System
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
TD Vaccine System
Intervention Description
Travelers' Diarrhea Vaccine System
Primary Outcome Measure Information:
Title
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
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
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
Secondary Outcome Measure Information:
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
Title
Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear
Time Frame
1 month
Title
Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group
Description
GMT
Time Frame
13 months
Title
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
Description
GMFR
Time Frame
13 months
Title
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group
Description
SCR
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Sheldon, MD
Organizational Affiliation
Miami Research Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Solano Clinical Research
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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Traveler's Diarrhea (TD) Automated Process

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