ETEC Logistics Trial (TREK) (Trek)
This study has been completed.
Sponsor:
Intercell USA, Inc.
Information provided by (Responsible Party):
Intercell USA, Inc.
ClinicalTrials.gov Identifier:
NCT00516659
First received: August 13, 2007
Last updated: March 13, 2012
Last verified: March 2012
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Purpose
This is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate the epidemiology of natural infection with ETEC occurring after transcutaneous immunization in a field setting.
| Condition | Intervention | Phase |
|---|---|---|
|
Diarrhea |
Biological: Heat-Labile Enterotoxin of Escherichia coli (LT) Biological: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | A Phase II, Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Epidemiology of Natural Infection With Enterotoxigenic Escherichia Coli Occurring After Transcutaneous Immunization in a Field Setting |
Resource links provided by NLM:
MedlinePlus related topics:
Diarrhea
Drug Information available for:
Escherichia coli
U.S. FDA Resources
Further study details as provided by Intercell USA, Inc.:
Primary Outcome Measures:
- Incidence of Enterotoxigenic Escherichia coli (ETEC) illness defined as a diarrheal episode associated with an LT, LT/ST, or ST-positive ETEC strain isolated from a sample of a stool [ Time Frame: during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode. ] [ Designated as safety issue: No ]
- Safety of heat-labile enterotoxin of Escherichia coli (LT) delivered by transcutaneous immunization (TCI) vs placebo [ Time Frame: From vaccination 1 to completion of Day 180 follow-up, about a seven month time period ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Stool frequency per episode of ETEC illness in placebo recipients [ Time Frame: Duration of stay in Mexico or Guatemala assessed up to four weeks ] [ Designated as safety issue: No ]
- Immunogenicity of LT delivered by TCI [ Time Frame: at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival ] [ Designated as safety issue: No ]
- Incidence of irritable bowel syndrome following travel to areas of ETEC endemnicity. [ Time Frame: Baseline through six months post return from Latin America. A period of about six months. ] [ Designated as safety issue: No ]
- Incidence of vaccine preventable outcome in placebo and LT patch recipients. [ Time Frame: Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days. ] [ Designated as safety issue: No ]
| Enrollment: | 201 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Group 1
Group 1 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 37.5µg LT
|
Biological: Heat-Labile Enterotoxin of Escherichia coli (LT)
Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.
|
|
Placebo Comparator: Group 2
Group 2 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 0µg LT (placebo patch containing no LT)
|
Biological: Placebo
The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.
|
Detailed Description:
The primary objectives of the study are to evaluate the incidence of ETEC illness in a field setting and to compare the safety of LT delivered by TCI with placebo. The secondary objectives include, but are not limited to:
evaluate the stool frequency per episode of ETEC illness in placebo recipients, to evaluate the immunogenicity of LT delivered by TCI, to evaluate the incidence of IBS following travel to areas of ETEC endemnicity, and to evaluate the incidence of VPO in placebo and LT patch recipients.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy adult men and women 18-64 years of age inclusive at screening
- Signed Informed Consent form
- Planned travel to an area within 2 ½ hours traveling distance of Cuernavaca or Guadalajara, Mexico or Antigua, Guatemala (minimum stay of 7 days)
- If female who is not post-menopausal or surgically sterile, negative pregnancy test (within 24 hours prior to vaccination) and agreement to employ an effective form of birth control or practice abstinence through the end of the study.
Exclusion Criteria:
- Clinically significant abnormalities as determined by the Investigator/clinician during physical inspection
- Received investigational product from 30 days before date of first vaccination or during the entire study period
- Ever received LT, ETEC, or cholera vaccine
- History of traveler's diarrhea within the previous year
- Travel to a developing country within the last year
- Women who are pregnant or breastfeeding
- History of achlorhydria
- Evidence of immunosuppression, including concomitant immunosuppressive therapy; fever > 99.5°F (37.5°C) on day of vaccination
- Current problems with alcohol or substance abuse
- An employee of the study clinic
- Sensitivity or allergy to any of the vaccine components
- History of significant blood loss, blood product donation, or blood product recipient in the previous 60 days
- Planned use of Imodium or antibiotics for self treatment of diarrhea during the study period
- Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites; and
- Medical history of acute or chronic GI illness or major GI surgery.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516659
Locations
| United States, California | |
| West Coast Clinical Trials | |
| Long Beach, California, United States, 90806 | |
| United States, Illinois | |
| Radiant Research | |
| Chicago, Illinois, United States, 60610 | |
| United States, Maryland | |
| Johns Hopkins University, Bloomberg School of Public Health | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Minnesota | |
| Twin Cities Clinical Research | |
| Minneapolis, Minnesota, United States, 55430 | |
| United States, New Jersey | |
| Advanced Biomedical Research | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Asthma Allergy & Associates | |
| Ithica, New York, United States, 14850 | |
| United States, Ohio | |
| Radiant Research | |
| Columbus, Ohio, United States, 43212 | |
| United States, Texas | |
| Radiant Research | |
| Dallas, Texas, United States, 75235 | |
| Center for Infectious Diseases, The University of Texas Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
| Breco Research | |
| Houston, Texas, United States, 77024 | |
| Radiant Research | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Jean Brown Research | |
| Salt Lake City, Utah, United States, 84124 | |
| United States, Washington | |
| Northwest Kinetics | |
| Tacoma, Washington, United States, 98418 | |
| Guatemala | |
| Private Clinic Antigua | |
| Antigua Guatemala, Guatemala, 03001 | |
| Mexico | |
| Private Clinic San Miguel | |
| San Miguel de Allende, Guanajuata, Mexico, 37700 | |
| Private Clinic Guadalajara | |
| Guadalajara, Jalisco, Mexico, 44690 | |
| AmeriMed Hospital | |
| Puerto Vallarta, Marina Vallarta, Mexico, 48334 | |
| Private Clinic Cuernavaca | |
| Cuernavaca, Morelos, Mexico, 62250 | |
| Hospital Americano | |
| Cancun, Quintana Roo, Mexico, 77500 | |
Sponsors and Collaborators
Intercell USA, Inc.
Investigators
| Principal Investigator: | Herbert L. DuPont, MD | Center for Infectious Diseases, The University of Texas Health Science Center at Houston |
| Principal Investigator: | Robin McKenzie, MD | Johns Hopkins University, Bloomberg School of Public Health |
| Principal Investigator: | Rama Yerramsetti | Breco Research, Houston, TX |
| Principal Investigator: | William P Jennings | Radiant Research, San Antonio, TX |
| Principal Investigator: | Yu-Luen Hsu | West Coast Clinical Trials, Long Beach, CA |
| Principal Investigator: | Christopher A Smith | Asthma & Allergy Associates, Ithaca, NY |
| Principal Investigator: | Benno G Roesch | Advanced Biomedical Research, Hackensack, NJ |
| Principal Investigator: | Jeffrey G Geohas | Radiant Research, Chicago, IL |
| Principal Investigator: | Gilbert Podolsky | Jean Brown Research, Salt Lake City, UT |
| Principal Investigator: | Thomas Lagen | Northwest Kinetics, Tacoma, WA |
| Principal Investigator: | Roy M Fleischmann | Radiant Research, Dallas, TX |
| Principal Investigator: | Douglas R Schumacher | Radiant Research, Columbus, OH |
| Principal Investigator: | Norman M Lunde | Twin Cities Clinical Research, Minneapolis, MN |
| Principal Investigator: | Francisco G Sandoval | Universidad Autonoma De Guadalajara, Mexico |
| Principal Investigator: | Juan Hector M Romero | Universidad Autonoma Guadalajara, Mexico |
| Principal Investigator: | Jaime B Gerson | University of Texas, Cuernavaca, Mexico |
| Principal Investigator: | Edwin Asturias | Universidad del Valle de Guatemala (Antigua) |
| Principal Investigator: | Roberto Garcia | AmeriMed Puerto Vallarta, Mexico |
| Principal Investigator: | Martha V Serrato | Hospital Americano, Cancun, Mexico |
| Principal Investigator: | Robert Maxwell | Private Clinic, San Miguel de Allende, Mexico |
More Information
Additional Information:
No publications provided by Intercell USA, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Intercell USA, Inc. |
| ClinicalTrials.gov Identifier: | NCT00516659 History of Changes |
| Other Study ID Numbers: | ELT206 |
| Study First Received: | August 13, 2007 |
| Last Updated: | March 13, 2012 |
| Health Authority: | United States: Food and Drug Administration Mexico: Ministry of Health Guatemala: Ministry of Health |
Keywords provided by Intercell USA, Inc.:
|
ETEC Traveler's diarrhea TCI patch vaccine |
diarrhea prevention epidemiology ETEC Escherichia coli |
Additional relevant MeSH terms:
|
Diarrhea Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013