Status:

COMPLETED

Yellow Fever Vaccine in Patients With Rheumatic Diseases

Lead Sponsor:

University of Sao Paulo General Hospital

Conditions:

Systemic Lupus

Rheumatoid Arthritis

Eligibility:

All Genders

2-60 years

Phase:

NA

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 a...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 31 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 24 2019

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT03430388

Start Date

January 31 2018

End Date

February 24 2019

Last Update

April 26 2019

Active Locations (1)

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

São Paulo, São Paulo, Brazil, 05403-000