Clinical trial NCT02383680: Yellow Fever Vaccination Under Low Dose Methotrexate Therapy
Official title: Yellow Fever Vaccination Under Low Dose Methotrexate Therapy - a Multi-Center Prospective Observational Controlled Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatic
Dermatologic Disorders
Keywords: Methotrexate therapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Tropical & Public Health Institute
name: Kantonsspital Aarau
name: Insel Gruppe AG, University Hospital Bern
name: University Hospital, Geneva
name: Centre Hospitalier Universitaire Vaudois
First posted: 2015-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Travelers seeking pre-travel advice with an indication for yellow fever vaccination will be addressed in 6 Swiss Travel Clinics of the Cantonal Hospital Aarau, the University Hospital in Bern, the University of Zurich, teh University Hospital of Geneva and the Swiss Tropical and Public Health Instutute in Basel

Brief summary: Travelers (n = 30, 15 taking low-dose methotrexate (MTX), 15 healthy controls (HC), seeking travel advice in one of the following Swiss Travel Centers (Aarau, Basel, Bern, Geneva, Lausanne, Zurich) and who have an indication for yellow fever (YF) vaccination according to the Swiss Federal Office of Public Health's vaccination recommendations are invited to participate in this study. After signing the consent form (i) YF viremia and (ii) anti-YF antibody production in patients taking low-dose MTX and HC will be compared after YF vaccination. It will be analyzed whether the percentage of people with protective antibodies differs between the two groups and (iii) vaccine side effects will be compared between the groups.

Detailed description: The study will be conducted in the form of a multi-center open-label prospective observational controlled pilot study. 15 patients under low dose methotrexate treatment and 15 healthy controls with an indication for yellow fever vaccination will be included. The study duration will be 28 days for each subject and will consist of 6 clinical visits on days 0, 3, 7, 10, 14 and 28.

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.

Eligibility criteria: Inclusion Criteria:

* Informed Consent as documented by signature
* 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:

* Contraindications on ethical grounds
* 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

Primary outcomes:
measure: Quantitative viremia in blood in travelers under low dose methotrexate (≤20mg/week) and healthy travelers
timeFrame: days 3, 7, 10 and 14 and 28
measure: Quantitative yellow fever specific neutralizing antibodies in blood of travelers under low dose methotrexate therapy (≤20mg/week) and healthy travelers
timeFrame: days 0, 7, 10, 14 and 28
Secondary outcomes:
measure: Determination of the percentage of travelers with an antibody level of >0.7 LNI (>0.5 IU/ml) in both groups
timeFrame: days 0, 7, 10, 14, 28
measure: Assessment of safety by determining the severity and quantity of adverse vaccine reactions such as local and systemic reactions in both study groups
timeFrame: Throughout day 28 after vaccination
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
state: Aargau
city: Basel
country: Switzerland
facility: Swiss Tropical and Public Health Institute
state: Basel Stadt
city: Bern
country: Switzerland
facility: Universitätsklinik für Infektiologie Inselspital
city: Geneva
country: Switzerland
facility: Médecine Tropicale et Humanitaire Hôpitaux Universitaires de Genève
city: Lausanne
country: Switzerland
facility: PMU | Policlinique médicale universitaire CHUV | Service des maladies infectieuses, Département de médecine
city: Zurich
country: Switzerland
facility: University of Zurich, Epidemiology, Biostatistics and Prevention Institute
Study officials:
affiliation: University of Zurich, Epidemiolgy, Biostatistics and Prevention Institute
name: Christoph Hatz, Prof MD
role: PRINCIPAL_INVESTIGATOR
References: