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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

May 2, 2008
March 13, 2012
October 2006
December 2006   (final data collection date for primary outcome measure)
To evaluate the immunogenicity of LT application at different doses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00672035 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prevention, Randomized, Double-Blinded, Placebo-Controlled, Parallel Assignment, Safety/Efficacy Study
Randomized, Double-Blinded, Placebo-Controlled, Dose Ranging Study to Assess the Immunogenicity and Safety of LT Application in Healthy Adults

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.

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Traveler's Diarrhea
Biological: Biological: heat-labile enterotoxin of E. coli (LT)
LT patch applied on either the deltoid or the lower back.
  • Experimental: 1
    7.5µg LT Dose placed at the Deltoid on Day 0 and Day 21
    Intervention: Biological: Biological: heat-labile enterotoxin of E. coli (LT)
  • Experimental: 2
    7.5µg LT Dose placed at the Lower Back on Day 0 and Day 21
    Intervention: Biological: Biological: heat-labile enterotoxin of E. coli (LT)
  • Experimental: 3
    22.5µg LT Dose placed at the Deltoid on Day 0 and Day 21
    Intervention: Biological: Biological: heat-labile enterotoxin of E. coli (LT)
  • Experimental: 4
    22.5µg LT Dose placed at the Lower Back on Day 0 and Day 21
    Intervention: Biological: Biological: heat-labile enterotoxin of E. coli (LT)
  • Experimental: 5
    37.5µg LT Dose placed at the Deltoid on Day 0 and Day 21
    Intervention: Biological: Biological: heat-labile enterotoxin of E. coli (LT)
  • Experimental: 6
    37.5µg LT Dose placed at the Lower Back on Day 0 and Day 21
    Intervention: Biological: Biological: heat-labile enterotoxin of E. coli (LT)
  • Experimental: 7
    50µg LT Dose placed at the Deltoid on Day 0 and Day 21
    Intervention: Biological: Biological: heat-labile enterotoxin of E. coli (LT)
  • Experimental: 8
    50µg LT Dose placed at the Lower Back on Day 0 and Day 21
    Intervention: Biological: Biological: heat-labile enterotoxin of E. coli (LT)
  • Placebo Comparator: 9
    Placebo (0µg LT) placed at the Deltoid on Day 0 and Day 21
    Intervention: Biological: Biological: heat-labile enterotoxin of E. coli (LT)
  • Placebo Comparator: 10
    Placebo (0µg LT) placed at the Lower Back on Day 0 and Day 21
    Intervention: Biological: Biological: heat-labile enterotoxin of E. coli (LT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
406
July 2008
December 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00672035
ELT202
No
Intercell USA, Inc.
Intercell USA, Inc.
Not Provided
Principal Investigator: Michael J Noss, MD Radiant Research, Cincinnati
Intercell USA, Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP