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| Name | Class |
|---|---|
| Swiss Tropical & Public Health Institute | OTHER |
| Kantonsspital Aarau | OTHER |
| Insel Gruppe AG, University Hospital Bern | OTHER |
| University Hospital, Geneva |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Healthy controls | Healthy travelers who have an indication for yellow fever vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yellow Fever Vaccination | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative viremia in blood in travelers under low dose methotrexate (≤20mg/week) and healthy travelers | Serum samples will be collected for PCR | days 3, 7, 10 and 14 and 28 |
| Quantitative yellow fever specific neutralizing antibodies in blood of travelers under low dose methotrexate therapy (≤20mg/week) and healthy travelers | Serum samples will be collected for measurement of neutralizing antibodies | days 0, 7, 10, 14 and 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the percentage of travelers with an antibody level of >0.7 LNI (>0.5 IU/ml) in both groups | days 0, 7, 10, 14, 28 | |
| Assessment of safety by determining the severity and quantity of adverse vaccine reactions such as local and systemic reactions in both study groups |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silja Bühler, MD MSc | Contact | +41 44634 | 4631 | silja.buehler@ifspm.uzh.ch |
| Christoph Hatz, Prof MD | Contact | +41 44634 | 4608 | christoph.hatz@unibas.ch |
| Name | Affiliation | Role |
|---|---|---|
| Christoph Hatz, Prof MD | University of Zurich, Epidemiolgy, Biostatistics and Prevention Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Aarau | Recruiting | Aarau | Canton of Aargau | 5001 | Switzerland |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
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| OTHER |
| Centre Hospitalier Universitaire Vaudois | OTHER |
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Serum
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Local and systemic vaccine reactions will be collected in a diray card filled out by the participant
| Throughout day 28 after vaccination |
| Swiss Tropical and Public Health Institute | Recruiting | Basel | Canton of Basel-City | 4051 | Switzerland |
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| Universitätsklinik für Infektiologie Inselspital | Not yet recruiting | Bern | Canton of Bern | 3010 | Switzerland |
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| Médecine Tropicale et Humanitaire Hôpitaux Universitaires de Genève | Not yet recruiting | Geneva | Canton of Geneva | 1211 | Switzerland |
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| University of Zurich, Epidemiology, Biostatistics and Prevention Institute | Recruiting | Zurich | Canton of Zurich | 8001 | Switzerland |
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| PMU | Policlinique médicale universitaire CHUV | Service des maladies infectieuses, Département de médecine | Not yet recruiting | Lausanne | 1011 | Switzerland |
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