Traveler's Diarrhea (TD) Automated Process

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT00751777
First received: September 11, 2008
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Prevention of Travelers' Diarrhea
Biological: heat-labile enterotoxin of E. coli (LT)
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Intercell USA, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo [ Time Frame: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 14, Day 21, Day 28, Day 35, Day 90, Day 194 ] [ Designated as safety issue: No ]

    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 [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
  • Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Evaluation of Duration of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: September 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: TD Vaccine System

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751777

Locations
United States, California
Solano Clinical Research
Vallejo, California, United States, 94589
United States, Florida
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Texas
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
  More Information

No publications provided

Responsible Party: Intercell USA, Inc.
ClinicalTrials.gov Identifier: NCT00751777     History of Changes
Other Study ID Numbers: ELT207
Study First Received: September 11, 2008
Results First Received: January 30, 2014
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diarrhea
Dysentery
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 18, 2014