ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Traveler's Diarrhea (TD) Automated Process

This study is currently recruiting participants.
Verified by Intercell USA, Inc., September 2008

Sponsored by: Intercell USA, Inc.
Information provided by: Intercell USA, Inc.
ClinicalTrials.gov Identifier: NCT00751777
  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 II

MedlinePlus related topics:   Diarrhea   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

Primary Outcome Measures:
  • Evaluation of immunogenicity of LT vaccine patch after first and second vaccination and comparison against placebo [ Time Frame: 7 months ] [ Designated as safety issue: No ]

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 ]

Estimated Enrollment:   120
Study Start Date:   September 2008
Estimated Study Completion Date:   November 2009
Estimated Primary Completion Date:   October 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
80 subjects will receive a two vaccination regimen with a LT patch.
Biological: heat-labile enterotoxin of E. coli (LT)
Travelers' Diarrhea Vaccine System
2: Placebo Comparator
40 subjects will receive a two vaccination regimen with a placebo patch.
Biological: Placebo
Travelers' Diarrhea 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

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

Locations
United States, California
Solano Clinical Research     Recruiting
      Vallejo, California, United States, 94589
      Contact: Brenda Grooms     707-556-1107 ext 230     bgrooms@solanoclinicalresearch.com    
      Principal Investigator: Peter Rogge, MD            
United States, Florida
Miami Research Associates     Recruiting
      South Miami, Florida, United States, 33143
      Contact: Maria Heimer     305-279-0015 ext 4231     mheimer@miamiresearch .com    
      Principal Investigator: Eric Sheldon, MD            
United States, Ohio
Radiant Research, Cincinnati     Recruiting
      Cincinnati, Ohio, United States, 45249
      Contact: Nancy Cipollone     513-247-5590     nancycipollone@radiantresearch.com    
      Principal Investigator: Michael Noss, MD            
United States, Texas
Clinical Trials of Texas     Recruiting
      San Antonio, Texas, United States, 78229
      Contact: Kay Scroggins     210-949-0122     kscroggins@cttexas.com    
      Principal Investigator: Elizabeth Tichy, MD            

Sponsors and Collaborators
Intercell USA, Inc.

Investigators
Principal Investigator:     Eric Sheldon, MD     Miami Research Associates    
  More Information


Responsible Party:   Intercell USA, Inc. ( Sarah Frech, Clinical Development Head )
Study ID Numbers:   ELT207
First Received:   September 11, 2008
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00751777
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Signs and Symptoms
Diarrhea
Signs and Symptoms, Digestive
Healthy

ClinicalTrials.gov processed this record on October 06, 2008




Links to all studies - primarily for crawlers