NCT02383680

Yellow Fever Vaccination Under Low Dose Methotrexate Therapy

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rheumatic
• Dermatologic Disorders

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-01-01
• Completion: 2016-06-01
• First posted: 2015-03-09
• Last updated: 2015-03-09

Locations

6 sites across 1 country: Switzerland