Yellow Fever Vaccination Under Low Dose Methotrexate Therapy (MTX_YF)

University of Zurich (UZH)

Status

Unknown

Conditions

Dermatologic Disorders

Rheumatic

Treatments

Biological: Yellow Fever Vaccination

Study type

Observational

Funder types

Other

Identifiers

NCT02383680

CS_2014_01

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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