Traveler's Diarrhea (TD) Automated Process - Full Text View

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:

MedlinePlus related topics: Diarrhea

U.S. FDA Resources

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
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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: 2 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

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
Last Updated:	March 13, 2012
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 May 22, 2013