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

Sponsor

Intercell USA, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00672035

Collaborator

(none)

406

Enrollment

Locations

Arms

Duration (Months)

81.2

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Traveler's Diarrhea	Biological: Biological: heat-labile enterotoxin of E. coli (LT)	Phase 2

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

406 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

To evaluate the immunogenicity of LT application at different doses [6 months]

Secondary Outcome Measures

To evaluate the safety of LT application at different doses [6 months]
To evaluate the safety of the skin preparation system [6 months]
To compare patch performance (safety and immunogenicity) on different anatomical parts of the body [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Solano Clinical Research	Davis	California	United States	95616
2	QUEST Research Institute	Bingham Farms	Michigan	United States	48025
3	Asthma and Allergy Associates PC	Cortland	New York	United States	13045
4	Radiant Research - Cincinnati	Cincinnati	Ohio	United States	45249
5	Clinical Trials of Texas	San Antonio	Texas	United States	78229