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

Immunogenicity and safety of primary yellow fever vaccination in patients with rheumatic diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-3875dd
Enrollment
Unknown
Registered
2020-03-05
Start date
2017-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccination

Interventions

This study will include two arms
one will include rheumatic patients who received inadvertent yellow fever first vacination (YF 17DD anti-mammalian Biomanguinhos-FIOCRUZ) in the 2017 Brazilian Campaignin in a period of less than 60 d
and the other arm will include rheumatic patients who received yellow fever first vacination (YF 17DD anti-mammalian Biomanguinhos-FIOCRUZ) in the 2017 Brazilian Campaign recommended by the attending
Biological/vaccine

Sponsors

Hospital Universitário Cassiano Antônio de Moraes
Lead Sponsor
Hospital Universitário Cassiano Antônio de Moraes
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

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: 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.

Design outcomes

Primary

MeasureTime frame
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. 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

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

Countries

Brazil

Contacts

Public ContactValéria Valim

Hospital Universitário Cassiano Antônio de Moraes

val.valim@gmail.com55(27)33357482

Outcome results

None listed

Source: REBEC (via WHO ICTRP)