中文(繁體)
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

Yellow Fever Vaccine in Patients With Rheumatic Diseases

只有註冊用戶可以翻譯文章
登陸註冊
鏈接已保存到剪貼板
狀態已完成
贊助商
University of Sao Paulo General Hospital

關鍵詞

抽象

According to World Health Organization (WHO), since December 2016, Brazil is showing a significant increase in cases of yellow fever in humans. In view of this, vaccination is suitable for residents and travelers to the risk area. However, for immunosuppressed patients there is a formal recommendation not to vaccinate with live virus vaccine. On the other hand, the safety and efficacy of the vaccine has been demonstrated in patients with HIV, and safety and seroconversion have also been demonstrated in patients with rheumatic disease who were inadvertently revaccinated for yellow fever. Faced with the impossibility of leaving the high-risk area for some patients the vaccination could be released to only those who have low level of immunosuppression as suggested by some recommendations of medical societies. The availability of a fractional vaccine in the State of São Paulo, which has proved its efficacy, opens the possibility of exposure to a lower number of copies of the virus in the first exposure of immunosuppressed patients, allowing, if necessary, a safer revaccination, after 28 days to obtain of a more effective immunogenic response. The objectives of the study are to evaluate the immune response of the immunization with fractional yellow fever vaccine (neutralizing antibodies) in patients with systemic autoimmune rheumatic diseases residing in a high-risk area. Secondarily, evaluate the possible association between immunogenicity and vaccination with: demographic data, clinical and laboratory activity of the disease in patients with chronic rheumatic diseases, evaluate the curve of viremia and report adverse events. Patients and healthy controls will be vaccinated for yellow fever in the Immunization Center of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP). The patients' screening for exclusion and inclusion criteria will be done at the rheumatology outpatient clinic after medical evaluation. For the controls will be the routine screening of the Immunization Center. The vaccination protocol will be a fractional dose of the yellow fever vaccine on day D0 for both groups. Patients will be evaluated on day D0, D5, D10, D30-4 and D365 and controls only on days D0, D10, D30-45 and D365 for aspartate aminotransferase (AST), alanine aminotransferase (ALT), platelets, urea and creatinine, immunoglobulin M (IgM) by immunofluorescence for Yellow Fever, viremia, autoantibodies.

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

Systemic Lupus
Rheumatoid Arthritis
Spondyloarthritis
Inflammatory Myopathy
Systemic Sclerosis
Mixed Connective Tissue Disease
Takayasu Arteritis
Granulomatosis With Polyangiitis
Sjogren's Syndrome
Juvenile Idiopathic Arthritis
Juvenile Dermatomyositis

干預/治療

Biological: Yellow Fever vaccine (17D)

-

手臂組

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
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]

Comparison of adverse events rates (based on the Brighton Collaboration diagnostic criteria) between rheumatic disease patients and healthy controls after Yellow Fever vaccine

2. Number of participants with protective levels of antibodies against Yellow Fever vaccine [30 days]

Comparison of protective antibodies rates (measured by indirect immunofluorescence) against Yellow Fever virus between rheumatic disease patients and healthy controls after Yellow Fever vaccine

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]

Association of number of patients with protective antibodies levels against yellow fever and disease activity in patients with chronic rheumatic diseases (measured by systemic lupus erythematosus disease activity index-SLEDAI for systemic lupus erythematosus patients, disease activity score-DAS28 for rheumatoid arthritis patients, manual muscle testing-MMT and disease activity score-DAS for inflammatory myopathies patients, Birmingham Vasculitis Activity Score-BVAS for primary vasculitis patients, juvenile arthritis disease activity score-JADAS for juvenile idiopathic arthritis patients)

2. Number of participants with persistent protective levels of antibodies against Yellow Fever [1 year]

Comparison of protective antibodies rates (measured by indirect immunofluorescence) against Yellow Fever virus between rheumatic disease patients and healthy controls after Yellow Fever vaccine

加入我們的臉書專頁

科學支持的最完整的草藥數據庫

  • 支持55種語言
  • 科學支持的草藥療法
  • 通過圖像識別草藥
  • 交互式GPS地圖-在位置標記草藥(即將推出)
  • 閱讀與您的搜索相關的科學出版物
  • 通過藥效搜索藥草
  • 組織您的興趣並及時了解新聞研究,臨床試驗和專利

輸入症狀或疾病,並閱讀可能有用的草藥,輸入草藥並查看其所針對的疾病和症狀。
*所有信息均基於已發表的科學研究

Google Play badgeApp Store badge