Traveler's Diarrhea (TD) Automated Process

NCT00751777 | Completed Phase 2 Results

• 1 other identifier: ELT207
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.

Conditions

Prevention of Travelers' Diarrhea

Outcome Measures

Primary Outcomes (3)

• Geometric Mean Titer (GMT) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo

  Day 0, Day 14, Day 21, Day 28, Day 35, Day 90, Day 194

• Geometric Mean Fold Ratio (GMFR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo

  GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.

  Day 14, Day 21, Day 28, Day 35, Day 90, Day 194

• Seroconversion (SCR) After First and Second Vaccination With LT Vaccine Patch and Comparison Against Placebo

  Definition of SCR: * Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline * Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline

  Day 14, Day 21, Day 28, Day 35, Day 90, Day 194

Secondary Outcomes (5)

• Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch

  13 months

• Evaluation of Residual LT in the Patch and on the Skin at the Patch Site Post-wear

  1 month

• Evaluation of LT-specific Immune Responses One-year After Original Treatment Regimen in LT Patch Group

  13 months

• Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group

  13 months

• Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group

  13 months

Study Arms (2)

Group 1: 37.5 µg LT patch

EXPERIMENTAL

80 subjects will receive a two vaccination regimen with a LT patch.

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

Group 2: 0 µg LT patch (placebo)

PLACEBO COMPARATOR

40 subjects will receive a two vaccination regimen with a placebo patch.

Biological: Placebo

Interventions

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

Travelers' Diarrhea Vaccine System

Also known as: TD Vaccine System

Group 1: 37.5 µg LT patch

Placebo BIOLOGICAL

Travelers' Diarrhea Vaccine System

Also known as: TD Vaccine System

Group 2: 0 µg LT patch (placebo)

Eligibility Criteria

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

You may qualify if:

• Healthy adult males or females, 18-64 years of age (inclusive) at the planned start of the study (first vaccination on Day 0)
• Signed Informed Consent
• Women who are not post-menopausal or surgically sterile must have a negative serum/urine pregnancy test at screening and within 24 hours of each vaccination with understanding (through Informed Consent process) to not become pregnant and 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 or diaphragm, with spermicide), and IUD.

You may not qualify if:

• Laboratory abnormalities \[as determined by the Toxicity Grading Scale (grade 1 4)\] at laboratory screening
• Abnormalities at physical examination \[as determined by the Toxicity Grading Scale (grade 1-4)\]
• Known allergies to any component of the vaccine
• Known allergies to adhesives
• Participated in research involving investigational product within 30 days before planned date of first vaccination or within 90 days after first vaccination
• Donated blood or blood products such as plasma within 30 days prior to planned date of first vaccination or within 90 days after 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™)
• History of diarrhea while traveling in a developing country within the last year
• 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
• Positive serology for HIV-1, HIV-2, HBsAg, or HCV
• Medical history of acute or chronic skin disease at vaccination area(s)
• Active skin allergy
• Signs of acute skin infection, sunburn or skin abnormalities at the vaccination area(s) including fungal infections, severe acne, or active contact dermatitis, or a history of keloid formation
• Excessively hirsute and unwilling to clip hair at the vaccination area(s)

Sponsors & Collaborators

• Intercell USA, Inc.: lead

Study Sites (3)

Solano Clinical Research

Vallejo, California, 94589, United States

Location

Miami Research Associates

South Miami, Florida, 33143, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Results Point of Contact

• Title: Head Clinical Development
• 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: 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: September 11, 2008
• First Posted: September 12, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 29, 2020
• Results First Posted: April 21, 2014

Record last verified: 2020-01

Locations

US (3)