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Trial record 8 of 9 for:    Interstitial | Recruiting, Not yet recruiting, Available Studies | "Scleroderma, Systemic"

Yellow Fever Vaccine in Patients With Rheumatic Diseases

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ClinicalTrials.gov Identifier: NCT03430388
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease Intervention/treatment Phase
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 Biological: Yellow Fever vaccine (17D) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area
Actual Study Start Date : January 31, 2018
Actual Primary Completion Date : March 24, 2018
Estimated Study Completion Date : February 24, 2019


Arm Intervention/treatment
Active Comparator: Rheumatic diseases patients
Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine
Biological: Yellow Fever vaccine (17D)
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
Biological: Yellow Fever vaccine (17D)
Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine




Primary Outcome Measures :
  1. Number of participants with severe adverse events to the fractional dose of Yellow Fever vaccine [ Time Frame: 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 [ Time Frame: 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


Secondary Outcome Measures :
  1. Association of number of patients with protective antibodies levels and disease activity in patients with chronic rheumatic diseases [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   2 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430388


Contacts
Contact: Eloisa Bonfa, MD, PhD 55 11 30617490 eloisa.bonfa@hc.fm.usp.br
Contact: Nádia Aikawa, MD, PhD 55 11 30617490 nadia.aikawa@hc.fm.usp.br

Locations
Brazil
Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo Recruiting
São Paulo, Sao Paulo, Brazil, 05403-000
Contact: Eloisa Bonfa, MD, PhD    55 11 30617490    eloisa.bonfa@hc.fm.usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Eloisa Bonfa, MD, PhD Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, SP - Brazil

Publications:

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03430388     History of Changes
Other Study ID Numbers: VFAReumatoHC
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Sao Paulo General Hospital:
vaccine
Yellow Fever
Rheumatic disease

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Lung Diseases, Interstitial
Arthritis
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Rheumatic Diseases
Sjogren's Syndrome
Spondylarthritis
Arthritis, Juvenile
Arteritis
Dermatomyositis
Collagen Diseases
Systemic Vasculitis
Connective Tissue Diseases
Yellow Fever
Granulomatosis with Polyangiitis
Takayasu Arteritis
Aortic Arch Syndromes
Myositis
Mixed Connective Tissue Disease
Joint Diseases
Musculoskeletal Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases