Yellow Fever Vaccine in Patients With Rheumatic Diseases

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03430388
• Date of registration: 30/01/2018
• Prospective Registration: Yes
• Primary sponsor: University of Sao Paulo General Hospital
• Public title: Yellow Fever Vaccine in Patients With Rheumatic Diseases
• Scientific title: Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area
• Date of first enrolment: January 31, 2018
• Target sample size: 600
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03430388
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Eloisa Bonfa, MD, PhD
• Affiliation: Rheumatology Division of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, SP - Brazil

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Inflammatory Myopathy

Sjogren's Syndrome

Spondyloarthritis

Mixed Connective Tissue Disease

Granulomatosis With Polyangiitis

Systemic Lupus

Takayasu Arteritis

Juvenile Idiopathic Arthritis

Rheumatoid Arthritis

Juvenile Dermatomyositis

Systemic Sclerosis

Intervention(s)

Biological: Yellow Fever vaccine (17D)

Primary Outcome(s)

Number of participants with protective levels of antibodies against Yellow Fever vaccine [Time Frame: 30 days]

Number of participants with severe adverse events to the fractional dose of Yellow Fever vaccine [Time Frame: 10 days]

Secondary Outcome(s)

Number of participants with persistent protective levels of antibodies against Yellow Fever [Time Frame: 1 year]

Association of number of patients with protective antibodies levels and disease activity in patients with chronic rheumatic diseases [Time Frame: 30 days]

Secondary ID(s)

VFAReumatoHC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors