Yellow Fever Vaccine in Patients With Rheumatic Diseases

NCT03430388 | Completed

• 1 other identifier: VFAReumatoHC
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

vaccine; Yellow Fever; Rheumatic disease

Outcome Measures

Primary Outcomes (2)

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

  Comparison of adverse events rates (based on the Brighton Collaboration diagnostic criteria) between rheumatic disease patients and healthy controls after Yellow Fever vaccine

  10 days

• Number of participants with protective levels of antibodies against Yellow Fever vaccine

  Comparison of protective antibodies rates (measured by indirect immunofluorescence) against Yellow Fever virus between rheumatic disease patients and healthy controls after Yellow Fever vaccine

  30 days

Secondary Outcomes (2)

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

  30 days

• Number of participants with persistent protective levels of antibodies against Yellow Fever

  1 year

Study Arms (2)

Rheumatic diseases patients

ACTIVE COMPARATOR

Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine

Biological: Yellow Fever vaccine (17D)

Healthy controls

ACTIVE COMPARATOR

Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine

Biological: Yellow Fever vaccine (17D)

Interventions

Yellow Fever vaccine (17D) BIOLOGICAL

Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine

Healthy controls; Rheumatic diseases patients

Eligibility Criteria

• Age: 2 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

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MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylarthritis; Myositis; Scleroderma, Systemic; Mixed Connective Tissue Disease; Takayasu Arteritis; Granulomatosis with Polyangiitis; Sjogren's Syndrome; Arthritis, Juvenile; Dermatomyositis; Yellow Fever; Rheumatic Diseases

Interventions

Yellow Fever Vaccine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylitis; Spinal Diseases; Bone Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases; Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Polymyositis; Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Eloisa Bonfa, MD, PhD

  Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, SP - Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 12, 2018
• Study Start: January 31, 2018
• Primary Completion: March 24, 2018
• Study Completion: February 24, 2019
• Last Updated: April 26, 2019

Record last verified: 2018-01

Locations

BR (1)