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.
Study Type
OBSERVATIONAL
Enrollment
30
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.
Kantonsspital Aarau
Aarau, Canton of Aargau, Switzerland
RECRUITINGSwiss Tropical and Public Health Institute
Basel, Canton of Basel-City, Switzerland
RECRUITINGUniversitätsklinik für Infektiologie Inselspital
Bern, Canton of Bern, Switzerland
NOT_YET_RECRUITINGMédecine Tropicale et Humanitaire Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, Switzerland
NOT_YET_RECRUITINGUniversity of Zurich, Epidemiology, Biostatistics and Prevention Institute
Zurich, Canton of Zurich, Switzerland
RECRUITINGPMU | Policlinique médicale universitaire CHUV | Service des maladies infectieuses, Département de médecine
Lausanne, Switzerland
NOT_YET_RECRUITINGQuantitative viremia in blood in travelers under low dose methotrexate (≤20mg/week) and healthy travelers
Serum samples will be collected for PCR
Time frame: 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
Time frame: days 0, 7, 10, 14 and 28
Determination of the percentage of travelers with an antibody level of >0.7 LNI (>0.5 IU/ml) in both groups
Time frame: 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
Local and systemic vaccine reactions will be collected in a diray card filled out by the participant
Time frame: Throughout day 28 after vaccination
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