Yellow Fever Vaccine in Patients With Rheumatic Diseases
關鍵詞
抽象
日期
最後驗證: | 12/31/2017 |
首次提交: | 01/29/2018 |
提交的預估入學人數: | 02/04/2018 |
首次發布: | 02/11/2018 |
上次提交的更新: | 04/24/2019 |
最近更新發布: | 04/25/2019 |
實際學習開始日期: | 01/30/2018 |
預計主要完成日期: | 03/23/2018 |
預計完成日期: | 02/23/2019 |
狀況或疾病
干預/治療
Biological: Yellow Fever vaccine (17D)
相
手臂組
臂 | 干預/治療 |
---|---|
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 |
資格標準
有資格學習的年齡 | 2 Years 至 2 Years |
有資格學習的性別 | All |
接受健康志願者 | 是 |
標準 | 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 |
結果
主要結果指標
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]
次要成果指標
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]