ETEC Logistics Trial (TREK) (Trek)
13 de marzo de 2012 actualizado por: Intercell USA, Inc.
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
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
201
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Long Beach, California, Estados Unidos, 90806
- West Coast Clinical Trials
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Illinois
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Chicago, Illinois, Estados Unidos, 60610
- Radiant Research
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Maryland
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Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins University, Bloomberg School of Public Health
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55430
- Twin Cities Clinical Research
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Advanced Biomedical Research
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New York
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Ithica, New York, Estados Unidos, 14850
- Asthma Allergy & Associates
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Ohio
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Columbus, Ohio, Estados Unidos, 43212
- Radiant Research
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Texas
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Dallas, Texas, Estados Unidos, 75235
- Radiant Research
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Houston, Texas, Estados Unidos, 77024
- Breco Research
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Houston, Texas, Estados Unidos, 77030
- Center for Infectious Diseases, The University of Texas Health Science Center at Houston
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San Antonio, Texas, Estados Unidos, 78229
- Radiant Research
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Utah
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Salt Lake City, Utah, Estados Unidos, 84124
- Jean Brown Research
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Washington
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Tacoma, Washington, Estados Unidos, 98418
- Northwest Kinetics
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Antigua Guatemala, Guatemala, 03001
- Private Clinic Antigua
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Guanajuata
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San Miguel de Allende, Guanajuata, México, 37700
- Private Clinic San Miguel
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Jalisco
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Guadalajara, Jalisco, México, 44690
- Private Clinic Guadalajara
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Marina Vallarta
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Puerto Vallarta, Marina Vallarta, México, 48334
- AmeriMed Hospital
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Morelos
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Cuernavaca, Morelos, México, 62250
- Private Clinic Cuernavaca
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Quintana Roo
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Cancun, Quintana Roo, México, 77500
- Hospital Americano
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 64 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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
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Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.
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Comparador de placebos: 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)
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The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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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
Periodo de tiempo: during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.
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during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.
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Safety of heat-labile enterotoxin of Escherichia coli (LT) delivered by transcutaneous immunization (TCI) vs placebo
Periodo de tiempo: From vaccination 1 to completion of Day 180 follow-up, about a seven month time period
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From vaccination 1 to completion of Day 180 follow-up, about a seven month time period
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Stool frequency per episode of ETEC illness in placebo recipients
Periodo de tiempo: Duration of stay in Mexico or Guatemala assessed up to four weeks
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Duration of stay in Mexico or Guatemala assessed up to four weeks
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Immunogenicity of LT delivered by TCI
Periodo de tiempo: at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival
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at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival
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Incidence of irritable bowel syndrome following travel to areas of ETEC endemnicity.
Periodo de tiempo: Baseline through six months post return from Latin America. A period of about six months.
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Baseline through six months post return from Latin America. A period of about six months.
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Incidence of vaccine preventable outcome in placebo and LT patch recipients.
Periodo de tiempo: Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.
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Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Herbert L. DuPont, MD, Center for Infectious Diseases, The University of Texas Health Science Center at Houston
- Investigador principal: Robin McKenzie, MD, Johns Hopkins University, Bloomberg School of Public Health
- Investigador principal: Rama Yerramsetti, Breco Research, Houston, TX
- Investigador principal: William P Jennings, Radiant Research, San Antonio, TX
- Investigador principal: Yu-Luen Hsu, West Coast Clinical Trials, Long Beach, CA
- Investigador principal: Christopher A Smith, Asthma & Allergy Associates, Ithaca, NY
- Investigador principal: Benno G Roesch, Advanced Biomedical Research, Hackensack, NJ
- Investigador principal: Jeffrey G Geohas, Radiant Research, Chicago, IL
- Investigador principal: Gilbert Podolsky, Jean Brown Research, Salt Lake City, UT
- Investigador principal: Thomas Lagen, Northwest Kinetics, Tacoma, WA
- Investigador principal: Roy M Fleischmann, Radiant Research, Dallas, TX
- Investigador principal: Douglas R Schumacher, Radiant Research, Columbus, OH
- Investigador principal: Norman M Lunde, Twin Cities Clinical Research, Minneapolis, MN
- Investigador principal: Francisco G Sandoval, Universidad Autonoma De Guadalajara, Mexico
- Investigador principal: Juan Hector M Romero, Universidad Autonoma Guadalajara, Mexico
- Investigador principal: Jaime B Gerson, University of Texas, Cuernavaca, Mexico
- Investigador principal: Edwin Asturias, Universidad del Valle de Guatemala (Antigua)
- Investigador principal: Roberto Garcia, AmeriMed Puerto Vallarta, Mexico
- Investigador principal: Martha V Serrato, Hospital Americano, Cancun, Mexico
- Investigador principal: Robert Maxwell, Private Clinic, San Miguel de Allende, Mexico
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2006
Finalización primaria (Actual)
1 de enero de 2007
Finalización del estudio (Actual)
1 de diciembre de 2007
Fechas de registro del estudio
Enviado por primera vez
13 de agosto de 2007
Primero enviado que cumplió con los criterios de control de calidad
14 de agosto de 2007
Publicado por primera vez (Estimar)
15 de agosto de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
14 de marzo de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
13 de marzo de 2012
Última verificación
1 de marzo de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ELT206
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .