Traveler's Diarrhea (TD) Automated Process

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Two Vaccination Regimen With an LT Vaccine Patch in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Prevention of Travelers' Diarrhea
• Intervention / Treatment: Biological: heat-labile enterotoxin of E. coli (LT); Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Vallejo, California, United States, 94589
      • Solano Clinical Research
  • Florida
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)
• Visible tattoos or marks (tattoos/scars) at the vaccination area(s) that would prevent appropriate dermatologic monitoring of the vaccination site(s)
• Fever greater than or equal to 38.0°C (100.4°F) at the time of planned vaccination
• Women who are pregnant or breastfeeding
• Acute illness at screening and unresolved at time of planned vaccination
• Employee of the investigational site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1: 37.5 µg LT patch; 80 subjects will receive a two vaccination regimen with a LT patch.	Biological: heat-labile enterotoxin of E. coli (LT); Travelers' Diarrhea Vaccine System; Other Names: TD Vaccine System
PLACEBO_COMPARATOR: Group 2: 0 µg LT patch (placebo); 40 subjects will receive a two vaccination regimen with a placebo patch.	Biological: Placebo; Travelers' Diarrhea Vaccine System; Other Names: TD Vaccine System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Safety of LT Vaccine Patch After First and Second Vaccination Compared to Placebo Patch	LT subjects (Group 1) were followed for six months longer (until Day 380) than Placebo subjects (Group 2) (until Day 194)	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	GMT	13 months
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group	GMFR	13 months
Evaluation of LT-specific Immune Responses One Year After Original Treatment Regimen in LT Patch Group	SCR	13 months

Collaborators and Investigators

• Sponsor: Intercell USA, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): November 1, 2009
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: September 11, 2008
• First Submitted That Met QC Criteria: September 11, 2008
• First Posted (ESTIMATE): September 12, 2008

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Diarrhea; Dysentery; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: ELT207