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

NCT00672035 | Completed Phase 2

• 1 other identifier: ELT202
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 5

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.

Conditions

Traveler's Diarrhea

Keywords

LT; Healthy Adults; Dose Ranging; Patch; Vaccine

Outcome Measures

Primary Outcomes (1)

• To evaluate the immunogenicity of LT application at different doses

  6 months

Secondary Outcomes (3)

• 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

Study Arms (10)

1

EXPERIMENTAL

7.5µg LT Dose placed at the Deltoid on Day 0 and Day 21

Biological: Biological: heat-labile enterotoxin of E. coli (LT)

2

EXPERIMENTAL

7.5µg LT Dose placed at the Lower Back on Day 0 and Day 21

Biological: Biological: heat-labile enterotoxin of E. coli (LT)

3

EXPERIMENTAL

22.5µg LT Dose placed at the Deltoid on Day 0 and Day 21

Biological: Biological: heat-labile enterotoxin of E. coli (LT)

4

EXPERIMENTAL

22.5µg LT Dose placed at the Lower Back on Day 0 and Day 21

Biological: Biological: heat-labile enterotoxin of E. coli (LT)

5

EXPERIMENTAL

37.5µg LT Dose placed at the Deltoid on Day 0 and Day 21

Biological: Biological: heat-labile enterotoxin of E. coli (LT)

6

EXPERIMENTAL

37.5µg LT Dose placed at the Lower Back on Day 0 and Day 21

Biological: Biological: heat-labile enterotoxin of E. coli (LT)

7

EXPERIMENTAL

50µg LT Dose placed at the Deltoid on Day 0 and Day 21

Biological: Biological: heat-labile enterotoxin of E. coli (LT)

8

EXPERIMENTAL

50µg LT Dose placed at the Lower Back on Day 0 and Day 21

Biological: Biological: heat-labile enterotoxin of E. coli (LT)

9

PLACEBO COMPARATOR

Placebo (0µg LT) placed at the Deltoid on Day 0 and Day 21

Biological: Biological: heat-labile enterotoxin of E. coli (LT)

10

PLACEBO COMPARATOR

Placebo (0µg LT) placed at the Lower Back on Day 0 and Day 21

Biological: Biological: heat-labile enterotoxin of E. coli (LT)

Interventions

Biological: heat-labile enterotoxin of E. coli (LT) BIOLOGICAL

LT patch applied on either the deltoid or the lower back.

1; 10; 2; 3; 4; 5; 6; 7; 8; 9

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Intercell USA, Inc.: lead

Study Sites (5)

Solano Clinical Research

Davis, California, 95616, United States

Location

QUEST Research Institute

Bingham Farms, Michigan, 48025, United States

Location

Asthma and Allergy Associates PC

Cortland, New York, 13045, United States

Location

Radiant Research - Cincinnati

Cincinnati, Ohio, 45249, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Study Officials

• Michael J Noss, MD

  Radiant Research, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: October 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: July 1, 2008
• Last Updated: March 14, 2012

Record last verified: 2012-03

Locations

US (5)