Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Yellow Fever Vaccine in Patients With Rheumatic Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03430388
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Tracking Information
First Submitted Date  ICMJE January 30, 2018
First Posted Date  ICMJE February 12, 2018
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE January 31, 2018
Actual Primary Completion Date March 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03430388 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yellow Fever Vaccine in Patients With Rheumatic Diseases
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • 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
Intervention  ICMJE Biological: Yellow Fever vaccine (17D)
Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine
Study Arms  ICMJE
  • Active Comparator: Rheumatic diseases patients
    Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine
    Intervention: Biological: Yellow Fever vaccine (17D)
  • Active Comparator: Healthy controls
    Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine
    Intervention: Biological: Yellow Fever vaccine (17D)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2018)
600
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 24, 2019
Actual Primary Completion Date March 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03430388
Other Study ID Numbers  ICMJE VFAReumatoHC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eloisa Bonfa, MD, PhD Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, SP - Brazil
PRS Account University of Sao Paulo General Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP