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Sponsored by: |
Intercell USA, Inc. |
Information provided by: | Intercell USA, Inc. |
ClinicalTrials.gov Identifier: | NCT00516659 |
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 II |
MedlinePlus related topics: | Diarrhea |
Study Type: | Interventional |
Study Design: | Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
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 |
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 |
Group 1: Active Comparator
Group 1 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 37.5µg LT
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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.
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Group 2: Placebo Comparator
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)
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Biological: Placebo
The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.
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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.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Show 19 Study Locations |
Intercell USA, Inc. |
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 |
Related Info 
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Responsible Party: | Iomai Corp. ( Dr. Sarah Frech ) |
Study ID Numbers: | ELT206 |
First Received: | August 13, 2007 |
Last Updated: | January 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00516659 |
Health Authority: | United States: Food and Drug Administration; Mexico: Ministry of Health; Guatemala: Ministry of Health |
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