Yellow Fever Vaccination Under Low Dose Methotrexate Therapy
NCT ID: NCT02383680
Last Updated: 2015-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2014-12-31
2016-06-30
Brief Summary
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Detailed Description
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YF antibodies will be measured on days 0, 7, 10, 14 and 28; viremia will be measured on days 3, 7, 10, 14 and 28.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients under low dose methotrexate therapy
Patients with various underlying conditions (e.g. rheumatic diseases, dermatologic diseases) who have an indication for yellow fever vaccination
Yellow Fever Vaccination
The Yellow Fever vaccination is actually not part of the study. Only individuals who have an indication for yellow fever vaccination according to Swiss vaccination recommendations will be enrolled. Study procedures will include blood collection to measure antibody development and viremia as well as data collection on possible side effects.
Healthy controls
Healthy travelers who have an indication for yellow fever vaccination
Yellow Fever Vaccination
The Yellow Fever vaccination is actually not part of the study. Only individuals who have an indication for yellow fever vaccination according to Swiss vaccination recommendations will be enrolled. Study procedures will include blood collection to measure antibody development and viremia as well as data collection on possible side effects.
Interventions
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Yellow Fever Vaccination
The Yellow Fever vaccination is actually not part of the study. Only individuals who have an indication for yellow fever vaccination according to Swiss vaccination recommendations will be enrolled. Study procedures will include blood collection to measure antibody development and viremia as well as data collection on possible side effects.
Eligibility Criteria
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Inclusion Criteria
* Indication for yellow fever vaccination according to Swiss FOPH recommendations
* Individuals under low dose MTX (≤20mg/week) therapy or healthy individuals
* Male and Female travelers ≥18 years to \<60 years of age
Exclusion Criteria
* Women who are pregnant or breast feeding
* Contraindication against yellow fever vaccination (e.g. hypersensitivity against vaccine ingredient)
* Current treatment with other immunosuppressive agent apart from low dose methotrexate
* Alemtuzumab or rituximab in the last year
* TNF-blocking therapy in past three months
* Immunocompromising condition in healthy control
* Other immunocompromising condition than MTX treatment itself and the underlying disease in patients under MTX
* Previous yellow fever vaccination
* No indication for yellow fever vaccination according to Swiss travel vaccination recommendations
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
18 Years
60 Years
ALL
Yes
Sponsors
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Swiss Tropical & Public Health Institute
OTHER
Kantonsspital Aarau
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
University Hospital, Geneva
OTHER
Centre Hospitalier Universitaire Vaudois
OTHER
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Christoph Hatz, Prof MD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich, Epidemiolgy, Biostatistics and Prevention Institute
Locations
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Kantonsspital Aarau
Aarau, Canton of Aargau, Switzerland
Swiss Tropical and Public Health Institute
Basel, Canton of Basel-City, Switzerland
Universitätsklinik für Infektiologie Inselspital
Bern, Canton of Bern, Switzerland
Médecine Tropicale et Humanitaire Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, Switzerland
University of Zurich, Epidemiology, Biostatistics and Prevention Institute
Zurich, Canton of Zurich, Switzerland
PMU | Policlinique médicale universitaire CHUV | Service des maladies infectieuses, Département de médecine
Lausanne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CS_2014_01
Identifier Type: -
Identifier Source: org_study_id
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