Yellow Fever Vaccine in Patients With Rheumatic Diseases

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Wegener’s Granulomatosis
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Brief Title

Yellow Fever Vaccine in Patients With Rheumatic Diseases

Official Title

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

Brief 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.

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 Association of number of patients with protective antibodies levels and disease activity in patients with chronic rheumatic diseases

Condition

Systemic Lupus

Intervention

Yellow Fever vaccine (17D)

Study Arms / Comparison Groups

 Rheumatic diseases patients
Description:  Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

600

Start Date

January 31, 2018

Completion Date

February 24, 2019

Primary Completion Date

March 24, 2018

Eligibility Criteria

        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

Gender

All

Ages

2 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Eloisa Bonfa, MD, PhD, ,

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations

NCT ID

NCT03430388

Organization ID

VFAReumatoHC

Responsible Party

Sponsor

Study Sponsor

University of Sao Paulo General Hospital

Study Sponsor

Eloisa Bonfa, MD, PhD, Principal Investigator, Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, SP - Brazil

Verification Date

January 2018