Prevention, Randomized, Double-Blinded, Placebo-Controlled, Parallel Assignment, Safety/Efficacy Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT00672035
First received: May 2, 2008
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

The main purpose of this study is to evaluate the body's immune response to the LT patch at different doses.

The secondary purpose of this study is to evaluate the safety of the LT patches at different doses and the safety of the skin preparation system. Another secondary purpose is to compare the safety and the body's immune response to LT patches placed on the upper arm versus the lower back.


Condition Intervention Phase
Traveler's Diarrhea
Biological: Biological: heat-labile enterotoxin of E. coli (LT)
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: Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging Study to Assess the Immunogenicity and Safety of LT Application in Healthy Adults

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To evaluate the immunogenicity of LT application at different doses [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety of LT application at different doses [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To evaluate the safety of the skin preparation system [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To compare patch performance (safety and immunogenicity) on different anatomical parts of the body [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 406
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
7.5µg LT Dose placed at the Deltoid on Day 0 and Day 21
Biological: Biological: heat-labile enterotoxin of E. coli (LT)
LT patch applied on either the deltoid or the lower back.
Experimental: 2
7.5µg LT Dose placed at the Lower Back on Day 0 and Day 21
Biological: Biological: heat-labile enterotoxin of E. coli (LT)
LT patch applied on either the deltoid or the lower back.
Experimental: 3
22.5µg LT Dose placed at the Deltoid on Day 0 and Day 21
Biological: Biological: heat-labile enterotoxin of E. coli (LT)
LT patch applied on either the deltoid or the lower back.
Experimental: 4
22.5µg LT Dose placed at the Lower Back on Day 0 and Day 21
Biological: Biological: heat-labile enterotoxin of E. coli (LT)
LT patch applied on either the deltoid or the lower back.
Experimental: 5
37.5µg LT Dose placed at the Deltoid on Day 0 and Day 21
Biological: Biological: heat-labile enterotoxin of E. coli (LT)
LT patch applied on either the deltoid or the lower back.
Experimental: 6
37.5µg LT Dose placed at the Lower Back on Day 0 and Day 21
Biological: Biological: heat-labile enterotoxin of E. coli (LT)
LT patch applied on either the deltoid or the lower back.
Experimental: 7
50µg LT Dose placed at the Deltoid on Day 0 and Day 21
Biological: Biological: heat-labile enterotoxin of E. coli (LT)
LT patch applied on either the deltoid or the lower back.
Experimental: 8
50µg LT Dose placed at the Lower Back on Day 0 and Day 21
Biological: Biological: heat-labile enterotoxin of E. coli (LT)
LT patch applied on either the deltoid or the lower back.
Placebo Comparator: 9
Placebo (0µg LT) placed at the Deltoid on Day 0 and Day 21
Biological: Biological: heat-labile enterotoxin of E. coli (LT)
LT patch applied on either the deltoid or the lower back.
Placebo Comparator: 10
Placebo (0µg LT) placed at the Lower Back on Day 0 and Day 21
Biological: Biological: heat-labile enterotoxin of E. coli (LT)
LT patch applied on either the deltoid or the lower back.

Detailed Description:

This is a randomized, double-blind, placebo-controlled, dose ranging, multicenter study. Subjects will be assigned to one of ten treatment groups and vaccinated according to the study group designation. Treatments will remain the same for first and second vaccinations (alternating left and right sides).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Subjects must meet all of the following criteria to be eligible to participate in the study:

Inclusion Criteria:

  • Healthy adult males or females 18 to 40 years of age with signed informed consent.
  • Women who are not post-menopausal or surgically sterile must have a negative serum or urine pregnancy test at screening and within 24 hours prior to each vaccination with understanding (through informed consent process) to not become pregnant over the duration of the study, and must agree 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, diaphragm with spermicide), and IUD.

Subjects meeting any of the following criteria are not eligible for participation in the study:

Exclusion Criteria:

  • Laboratory abnormalities.
  • Abnormalities at physical examination
  • Known allergies to any component of the vaccine.
  • Known disturbance of coagulation.
  • Known allergies to adhesives.
  • Participated in unrelated research involving investigational product within 30 days before planned date of 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™).
  • Medical history of acute or chronic skin disease at vaccination site(s).
  • Active skin allergy.
  • Recent or regular use of oral or injected steroid medications.
  • Use of immunosuppressive systemic steroid medications including inhaled steroids within three months prior to first vaccination.
  • Comorbid conditions or treatments that are immunosuppressive, including cancer, diabetes, end-stage renal disease, as determined by the Investigator.
  • Positive serology for HIV-1, HIV-2, HBsAg, or HCV.
  • History of severe atopy. Signs or history of acute skin infection, sunburn or skin abnormalities on the vaccination area(s) including fungal infections, severe acne, history of keloid formation, or active contact dermatitis.
  • Artificial tanning (UV radiation) over the duration of the study including the screening period.
  • Hirsute (significant amount of hair) at vaccination area(s).
  • Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatological monitoring of the vaccination site(s).
  • Fever equal to or greater than 38.0°C (≥100.4°F) at the time of planned vaccination.
  • Suspicion of or recent history of alcohol or substance abuse.
  • Donated blood or blood products such as plasma within the past 30 days.
  • Women who are pregnant or breastfeeding.
  • Employee of the investigational site.
  • Medical history of achlorhydria.
  • 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.
  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: NCT00672035

Locations
United States, California
Solano Clinical Research
Davis, California, United States, 95616
United States, Michigan
QUEST Research Institute
Bingham Farms, Michigan, United States, 48025
United States, New York
Asthma and Allergy Associates PC
Cortland, New York, United States, 13045
United States, Ohio
Radiant Research - Cincinnati
Cincinnati, Ohio, United States, 45249
United States, Texas
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Intercell USA, Inc.
Investigators
Principal Investigator: Michael J Noss, MD Radiant Research, Cincinnati
  More Information

No publications provided

Responsible Party: Intercell USA, Inc.
ClinicalTrials.gov Identifier: NCT00672035     History of Changes
Other Study ID Numbers: ELT202
Study First Received: May 2, 2008
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Intercell USA, Inc.:
LT
Healthy Adults
Dose Ranging
Patch
Vaccine

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 July 20, 2014