Yellow Fever Vaccination Under Low Dose Methotrexate Therapy — MTX_YF  

Dermatologic Disorders Clinical Trial

Official title: Yellow Fever Vaccination Under Low Dose Methotrexate Therapy - a Multi-Center Prospective Observational Controlled Pilot Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dermatologic Disorders
• Rheumatic
• Skin Diseases
• Yellow Fever

• NCT number: NCT02383680
• Study type: Observational
• Source: University of Zurich
• Contact: Silja Bühler, MD MSc
• Phone: +41 44634
• Email: silja.buehler@ifspm.uzh.ch
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Completion date: June 2016