Yellow Fever Vaccination Under Low Dose Methotrexate Therapy
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 02/28/2015 |
| Primero enviado: | 03/02/2015 |
| Inscripción estimada enviada: | 03/02/2015 |
| Publicado por primera vez: | 03/08/2015 |
| Última actualización enviada: | 03/02/2015 |
| Última actualización publicada: | 03/08/2015 |
| Fecha de inicio real del estudio: | 11/30/2014 |
| Fecha estimada de finalización primaria: | 12/31/2015 |
| Fecha estimada de finalización del estudio: | 05/31/2016 |
Condición o enfermedad
Intervención / tratamiento
Biological: Yellow Fever Vaccination
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| 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 |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Método de muestreo | Non-Probability Sample |
| Acepta voluntarios saludables | si |
| Criterios | 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 |
Salir
Medidas de resultado primarias
1. Quantitative viremia in blood in travelers under low dose methotrexate (≤20mg/week) and healthy travelers [days 3, 7, 10 and 14 and 28]
2. Quantitative yellow fever specific neutralizing antibodies in blood of travelers under low dose methotrexate therapy (≤20mg/week) and healthy travelers [days 0, 7, 10, 14 and 28]
Medidas de resultado secundarias
1. 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]
2. Assessment of safety by determining the severity and quantity of adverse vaccine reactions such as local and systemic reactions in both study groups [Throughout day 28 after vaccination]
