Yellow Fever Vaccine in Patients With Rheumatic Diseases
Condition: 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
MeSH terms: Yellow Fever; Arthritis; Rheumatic Diseases; Sjogren's Syndrome; Arthritis, Juvenile; Dermatomyositis; Myositis; Granulomatosis with Polyangiitis; Arteritis; Takayasu Arteritis; Aortic Arch Syndromes; Scleroderma, Systemic; Collagen Diseases; Connective Tissue Diseases; Mixed Connective Tissue Disease
Study type: Interventional

Summary: 
      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.
    


Intervention name(s): Yellow Fever vaccine (17D)
Intervention type(s): Biological
Intervention description(s): Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; Yellow Fever; Rheumatic disease