Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

NCT01067781 | Completed Phase 2 Results

• 1 other identifier: ELT208
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing

Conditions

Diarrhea

Keywords

Prevention of Travelers' Diarrhea

Outcome Measures

Primary Outcomes (1)

• Characterization and Comparison of the Safety of the TD Vaccine System: (1) Solicited and Unsolicited Adverse Events (AEs) (2) Clinical Laboratory Safety (3) Serious AEs

  Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited.

  Day 0 to Day 180

Secondary Outcomes (3)

• Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Titers

  Day 0 to Day 180

• Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Geometric Mean Fold Ratios

  Day 0 to Day 180

• Characterization and Comparison of Group LT-specific Immune Responses to the TD Vaccine System: Seroconversion Rates

  Day 0 to Day 180

Study Arms (4)

1

EXPERIMENTAL

Two vaccination regimen with an LT patch (no swabbing)

Biological: Heat-Labile Enterotoxin of E. coli (LT)

2

EXPERIMENTAL

Two vaccination regimen with an LT patch (with swabbing)

Biological: Heat-Labile Enterotoxin of E. coli (LT)

3

PLACEBO COMPARATOR

Two vaccination regimen with a placebo patch (no swabbing)

Biological: Placebo

4

PLACEBO COMPARATOR

Two vaccination regimen with a placebo patch (with swabbing)

Biological: Placebo

Interventions

Heat-Labile Enterotoxin of E. coli (LT) BIOLOGICAL

Travelers' Diarrhea Vaccine System

1; 2

Placebo BIOLOGICAL

Travelers' Diarrhea Vaccine System

3; 4

Eligibility Criteria

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

You may qualify if:

• A female or male 18-64 (inclusive) years of age;
• In good health as determined by medical history and screening exam;
• Females who are post-menopausal, surgically sterile, or have a negative serum/urine pregnancy test at Day 0 and agree not to become pregnant for the duration of study.

You may not qualify if:

• Abnormalities at physical exam \[as determined by the Toxicity Grading Scale (Grade 1-4)\];
• Laboratory abnormalities \[as determined by the Toxicity Grading Scale (Grade 1 4)\] at screening;
• Participated in 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;
• Women who are pregnant or breastfeeding;
• Clinically significant underlying enteric, pulmonary, cardiac or renal disease;
• Current seizure disorder;
• Current use of immunosuppressive therapy (inhaled steroids are allowed);
• Known or suspected alcohol abuse or illicit drug use within the last year;
• Positive Serology for HIV-1, HIV-2, HbsAg, or HCV;
• Known allergies to any component of the vaccine including adhesives;
• An employee of the study site;
• An employee of Intercell (global) or an immediate family member;
• Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites;
• Receipt of any routine vaccinations within 7 days prior to, or following, the date of planned study vaccinations.

Sponsors & Collaborators

• Intercell USA, Inc.: lead

Study Sites (5)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Johnson County Clinical Trials

Lenexa, Kansas, 66219, United States

Location

Radiant Research

Cincinnati, Ohio, 45249, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Related Links

• Intercell Home Page

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Head Clinical Developement
• Organization: Valneva Austria GmbH

info@valneva.com

0043120620

Study Officials

• Eric Sheldon, MD

  Miami Research Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 12, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: March 1, 2012
• Last Updated: February 10, 2020
• Results First Posted: March 13, 2014

Record last verified: 2020-02

Locations

US (5)