Effectiveness and safety of yellow fever vaccination in patients with rheumatic diseases

Not Applicable

Recruiting

• Conditions: Vaccination; Yellow Fever Vaccine; Yellow Fever Virus; Autoimmune Disease.; E02.095.465.425.400.530.890; D20.215.894.899.970; B04.820.250.350.990; C20.111

• Registration Number: RBR-3875dd
• Lead Sponsor: Hospital Universitário Cassiano Antônio de Moraes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

The present study included patients with rheumatic diseases including Rheumatoid Arthritis, Systemic Erythematosus Lupus, Sjögren Syndrome, Systemic Sclerosis and Spondylarthritis over 18 years of age who received yellow fever 17DD anti-mammalian first vaccination in the 2017 Brazilian Campaign from January until December 2017. The control group consisted of individuals who spontaneously searched the Rheumatology Service of HUCAM to receive yellow fever first vacination YF 17DD antimammalian Biomanguinhos-FIOCRUZ in the 2017 Brazilian Campaign and who did not have immune mediated rheumatic disease and no history of previous yellow fever vaccination.

Exclusion Criteria

Exclusion criteria included patients under 18 years of age, patients with history of previous yellow fever vaccination, patients external to HUCAM who have not been referred by a rheumatologist by letter or direct contact of the attending physician indicating the diagnosis and medications in use, those who do not agree to participate; patients immunosuppressed by other causes such as HIV infected, CD4 count less than 200 cells per mm3, organ transplantation history, primary immunodeficiency, neoplasia, previous history of timus disease.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The accomplishment of this study will allow to evaluate the safety and effectiveness of the primary vaccination against yellow fever in patients with rheumatologic diseases. It is generally expected that the vaccine will be safe for this group of patients, but with a lower vaccine response associated with disease activity and greater inflammatory response.<br>The primary endpoint will be to assess the seroconversion rate through the PRNT technique 28 days after receiving the vaccine (17DD YF -Instituto Biomanguinhos-FIOCRUZ)

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint will be to evaluate possible adverse events related to the administration of the 17DD YF-Instituto Biomanguinhos-FIOCRUZ vaccine.