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临床试验/NCT03430388
NCT03430388已完成不适用

Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2018年1月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
2
主要终点
Number of participants with severe adverse events to the fractional dose of Yellow Fever vaccine

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
2 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Rheumatic diseases patients

Active Comparator

Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine

干预措施: Yellow Fever vaccine (17D) (Biological)

Healthy controls

Active Comparator

Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine

干预措施: Yellow Fever vaccine (17D) (Biological)

结局指标

主要结局

Number of participants with severe adverse events to the fractional dose of Yellow Fever vaccine

时间窗: 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

Number of participants with protective levels of antibodies against Yellow Fever vaccine

时间窗: 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

次要结局

  • Association of number of patients with protective antibodies levels and disease activity in patients with chronic rheumatic diseases(30 days)
  • Number of participants with persistent protective levels of antibodies against Yellow Fever(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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