Yellow Fever Vaccine in Patients With Rheumatic Diseases

Related Clinical Trial
Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis Hydroxychloroquine in ANCA Vasculitis Evaluation Vasculitis Illness Perception (VIP) Study Reproductive Health in Men and Women With Vasculitis Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis Impact of Vasculitis on Employment and Income Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases VCRC Tissue Repository Yellow Fever Vaccine in Patients With Rheumatic Diseases Journey of Patients With Vasculitis From First Symptom to Diagnosis One-Time DNA Study for Vasculitis Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Autologous Peripheral Blood Stem Cell Transplantation in Patients With Life Threatening Autoimmune Diseases Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. Clinical Transcriptomics in Systemic Vasculitis (CUTIS) The ANCA Vasculitis Questionnaire (AAV-PRO©) Vasculitis Pregnancy Registry VCRC Patient Contact Registry Patient-Reported Data Validation Study Educational Needs of Patients With Systemic Vasculitis Diagnostic Effectiveness of Virtual Bronchoscopy Alemtuzumab for ANCA Associated Refractory Vasculitis Interventional Cryotherapy for the Eradication of Benign Airway Disease (“ICE the BAD”) PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides Plasma Exchange for Renal Vasculitis PRO Development for ANCA Associated Vasculitis BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides Pulse Versus Continuous Cyclophosphamide for Induction of Remission in ANCA-Associated Vasculitides Rituximab Vasculitis Maintenance Study Anti-Cytokine Therapy for Vasculitis Rituximab and Belimumab Combination Therapy in PR3 COMBIVAS American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis Low-dose Glucocorticoid Vasculitis Induction Study Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study Evaluate the Remission MAINtenance Using Extended Administration of Prednisone in Systemic Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis. The Assessment of Prednisone In Remission Trial (TAPIR) – Patient Centric Approach Steroids and Methotrexate to Treat Systemic Vasculitis Efficacy Study of Two Treatments in the Remission of Vasculitis Assessment of Lung Inflammation in Patients With Atopic Asthma Using Positron Emission Tomography The Assessment of Prednisone In Remission Trial – Centers of Excellence Approach Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener’s) Rituximab for the Treatment of Wegener’s Granulomatosis and Microscopic Polyangiitis Cyclophosphamide and Prednisone Followed by Methotrexate To Treat Vasculitides Maintenance of Remission With Rituximab Versus Azathioprine for Newly-diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener’s) or Microscopic Polyangiitis Longitudinal Study for Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) Longitudinal Protocol for Granulomatosis With Polyangiitis (Wegener’s) and Microscopic Polyangiitis Mycophenolate Mofetil for Treatment of Relapses of Wegener’s Disease or Microscopic Polyangiitis (MPA) Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) Daclizumab to Treat Wegener’s Granulomatosis An Open Label Pilot Study Examining the Use of Rituximab in Patients With Wegener’s Granulomatosis Who Have Experienced Disease Relapse on Standard Therapies Etanercept to Treat Wegener’s Granulomatosis Treatment of Wegener’s Granulomatosis With Cyclophosphamide Mycophenolate Mofetil to Treat Wegener’s Granulomatosis and Related Vascular Inflammatory Conditions Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener’s Granulomatosis Comparison of Treatments to Maintain Disease Remission in Patients With Wegener’s Granulomatosis and Related Vasculitis Syndromes Neutrophils as Prognostic Factors in Granulomatosis With Polyangiitis (Formerly Named Wegener’s Granulomatosis) Natural History of Granulomatosis With Polyangiitis: Clinical and Genetic Biomarkers of Airway Disease NoAAC PR-03 Study Analysis of Bronchial Tissue and Fluid in Patients With Wegener’s Granulomatosis TEMPO Study: Trimethoprim-Sulfamethoxazole in Granulomatosis With Polyangiitis Cardiovascular Involvement in Patients With Granulomatosis With Polyangiitis An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener’s) or Microscopic Polyangiitis Study of One Protein Implicated in Wegener Disease Abatacept in Treating Adults With Mild Relapsing Wegener’s Granulomatosis Phase II Study on Gusperimus in Patients With Refractory Wegener’s Granulomatosis Etanercept for Wegener’s Granulomatosis Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener’s Granulomatosis

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