Yellow Fever Vaccine in Patients With Rheumatic Diseases
Palabras clave
Abstracto
fechas
Verificado por última vez: | 12/31/2017 |
Primero enviado: | 01/29/2018 |
Inscripción estimada enviada: | 02/04/2018 |
Publicado por primera vez: | 02/11/2018 |
Última actualización enviada: | 04/24/2019 |
Última actualización publicada: | 04/25/2019 |
Fecha de inicio real del estudio: | 01/30/2018 |
Fecha estimada de finalización primaria: | 03/23/2018 |
Fecha estimada de finalización del estudio: | 02/23/2019 |
Condición o enfermedad
Intervención / tratamiento
Biological: Yellow Fever vaccine (17D)
Fase
Grupos de brazos
Brazo | Intervención / tratamiento |
---|---|
Active Comparator: Rheumatic diseases patients Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine | |
Active Comparator: Healthy controls Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine |
Criterio de elegibilidad
Edades elegibles para estudiar | 2 Years A 2 Years |
Sexos elegibles para estudiar | All |
Acepta voluntarios saludables | si |
Criterios | Inclusion Criteria: - Rheumatic disease under low immunosuppression (hydroxychloroquine, sulfasalazine or methotrexate plus prednisone up to 7,5mg/day or leflunomide plus prednisone up to 7,5mg/day), - Resident in high risk área for Yellow Fever Exclusion Criteria: - Active disease - Primary immunodeficiency - History of anaphylactic response to vaccine components or egg allergy - Living outside the risk area - Do not meet criteria for low immunosuppression - History of previous immunization with the yellow fever vaccine - History of live virus vaccine up to 4 weeks before - Individuals who do not agree to participate in the study and/or whose parents do not agree to participate in the study |
Salir
Medidas de resultado primarias
1. Number of participants with severe adverse events to the fractional dose of Yellow Fever vaccine [10 days]
2. Number of participants with protective levels of antibodies against Yellow Fever vaccine [30 days]
Medidas de resultado secundarias
1. Association of number of patients with protective antibodies levels and disease activity in patients with chronic rheumatic diseases [30 days]
2. Number of participants with persistent protective levels of antibodies against Yellow Fever [1 year]