ETEC Logistics Trial (TREK) (Trek)
13. mars 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
201
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Long Beach, California, Forente stater, 90806
- West Coast Clinical Trials
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Illinois
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Chicago, Illinois, Forente stater, 60610
- Radiant Research
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Maryland
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Baltimore, Maryland, Forente stater, 21205
- Johns Hopkins University, Bloomberg School of Public Health
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55430
- Twin Cities Clinical Research
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Advanced Biomedical Research
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New York
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Ithica, New York, Forente stater, 14850
- Asthma Allergy & Associates
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Ohio
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Columbus, Ohio, Forente stater, 43212
- Radiant Research
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Texas
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Dallas, Texas, Forente stater, 75235
- Radiant Research
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Houston, Texas, Forente stater, 77024
- Breco Research
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Houston, Texas, Forente stater, 77030
- Center for Infectious Diseases, The University of Texas Health Science Center at Houston
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San Antonio, Texas, Forente stater, 78229
- Radiant Research
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Utah
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Salt Lake City, Utah, Forente stater, 84124
- Jean Brown Research
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Washington
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Tacoma, Washington, Forente stater, 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, Mexico, 37700
- Private Clinic San Miguel
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Jalisco
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Guadalajara, Jalisco, Mexico, 44690
- Private Clinic Guadalajara
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Marina Vallarta
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Puerto Vallarta, Marina Vallarta, Mexico, 48334
- AmeriMed Hospital
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Morelos
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Cuernavaca, Morelos, Mexico, 62250
- Private Clinic Cuernavaca
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Quintana Roo
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Cancun, Quintana Roo, Mexico, 77500
- Hospital Americano
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 64 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: 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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Placebo komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Stool frequency per episode of ETEC illness in placebo recipients
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Herbert L. DuPont, MD, Center for Infectious Diseases, The University of Texas Health Science Center at Houston
- Hovedetterforsker: Robin McKenzie, MD, Johns Hopkins University, Bloomberg School of Public Health
- Hovedetterforsker: Rama Yerramsetti, Breco Research, Houston, TX
- Hovedetterforsker: William P Jennings, Radiant Research, San Antonio, TX
- Hovedetterforsker: Yu-Luen Hsu, West Coast Clinical Trials, Long Beach, CA
- Hovedetterforsker: Christopher A Smith, Asthma & Allergy Associates, Ithaca, NY
- Hovedetterforsker: Benno G Roesch, Advanced Biomedical Research, Hackensack, NJ
- Hovedetterforsker: Jeffrey G Geohas, Radiant Research, Chicago, IL
- Hovedetterforsker: Gilbert Podolsky, Jean Brown Research, Salt Lake City, UT
- Hovedetterforsker: Thomas Lagen, Northwest Kinetics, Tacoma, WA
- Hovedetterforsker: Roy M Fleischmann, Radiant Research, Dallas, TX
- Hovedetterforsker: Douglas R Schumacher, Radiant Research, Columbus, OH
- Hovedetterforsker: Norman M Lunde, Twin Cities Clinical Research, Minneapolis, MN
- Hovedetterforsker: Francisco G Sandoval, Universidad Autonoma De Guadalajara, Mexico
- Hovedetterforsker: Juan Hector M Romero, Universidad Autonoma Guadalajara, Mexico
- Hovedetterforsker: Jaime B Gerson, University of Texas, Cuernavaca, Mexico
- Hovedetterforsker: Edwin Asturias, Universidad del Valle de Guatemala (Antigua)
- Hovedetterforsker: Roberto Garcia, AmeriMed Puerto Vallarta, Mexico
- Hovedetterforsker: Martha V Serrato, Hospital Americano, Cancun, Mexico
- Hovedetterforsker: Robert Maxwell, Private Clinic, San Miguel de Allende, Mexico
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2006
Primær fullføring (Faktiske)
1. januar 2007
Studiet fullført (Faktiske)
1. desember 2007
Datoer for studieregistrering
Først innsendt
13. august 2007
Først innsendt som oppfylte QC-kriteriene
14. august 2007
Først lagt ut (Anslag)
15. august 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. mars 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. mars 2012
Sist bekreftet
1. mars 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ELT206
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