- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00516659
ETEC Logistics Trial (TREK) (Trek)
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
-
-
California
-
Long Beach, California, Estados Unidos, 90806
- West Coast Clinical Trials
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60610
- Radiant Research
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins University, Bloomberg School of Public Health
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55430
- Twin Cities Clinical Research
-
-
New Jersey
-
Hackensack, New Jersey, Estados Unidos, 07601
- Advanced Biomedical Research
-
-
New York
-
Ithica, New York, Estados Unidos, 14850
- Asthma Allergy & Associates
-
-
Ohio
-
Columbus, Ohio, Estados Unidos, 43212
- Radiant Research
-
-
Texas
-
Dallas, Texas, Estados Unidos, 75235
- Radiant Research
-
Houston, Texas, Estados Unidos, 77024
- Breco Research
-
Houston, Texas, Estados Unidos, 77030
- Center for Infectious Diseases, The University of Texas Health Science Center at Houston
-
San Antonio, Texas, Estados Unidos, 78229
- Radiant Research
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84124
- Jean Brown Research
-
-
Washington
-
Tacoma, Washington, Estados Unidos, 98418
- Northwest Kinetics
-
-
-
-
-
Antigua Guatemala, Guatemala, 03001
- Private Clinic Antigua
-
-
-
-
Guanajuata
-
San Miguel de Allende, Guanajuata, México, 37700
- Private Clinic San Miguel
-
-
Jalisco
-
Guadalajara, Jalisco, México, 44690
- Private Clinic Guadalajara
-
-
Marina Vallarta
-
Puerto Vallarta, Marina Vallarta, México, 48334
- AmeriMed Hospital
-
-
Morelos
-
Cuernavaca, Morelos, México, 62250
- Private Clinic Cuernavaca
-
-
Quintana Roo
-
Cancun, Quintana Roo, México, 77500
- Hospital Americano
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: 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
|
Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.
|
Comparador de Placebo: 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)
|
The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
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
Prazo: during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.
|
during the diarrheal episode or within 48 hours after the last stool in the diarrheal episode.
|
Safety of heat-labile enterotoxin of Escherichia coli (LT) delivered by transcutaneous immunization (TCI) vs placebo
Prazo: From vaccination 1 to completion of Day 180 follow-up, about a seven month time period
|
From vaccination 1 to completion of Day 180 follow-up, about a seven month time period
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Stool frequency per episode of ETEC illness in placebo recipients
Prazo: Duration of stay in Mexico or Guatemala assessed up to four weeks
|
Duration of stay in Mexico or Guatemala assessed up to four weeks
|
Immunogenicity of LT delivered by TCI
Prazo: at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival
|
at least three weeks prior to arrival in country, arrival in Mexico or Guatemala, and 5 to 18 days after arrival
|
Incidence of irritable bowel syndrome following travel to areas of ETEC endemnicity.
Prazo: Baseline through six months post return from Latin America. A period of about six months.
|
Baseline through six months post return from Latin America. A period of about six months.
|
Incidence of vaccine preventable outcome in placebo and LT patch recipients.
Prazo: Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.
|
Duration of each individual participant stay in Mexico or Guatemala ranging from 7 to 28 Days.
|
Colaboradores e Investigadores
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
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ELT206
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .