NCT03430388

Yellow Fever Vaccine in Patients With Rheumatic Diseases

Completed NA Last updated 26 April 2019

What this trial tests

NA trial testing Yellow Fever vaccine (17D) in Systemic Lupus in 600 participants. Completed in 24 February 2019.

Timeline

31 January 2018

Primary endpoint
24 March 2018

24 February 2019

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	600
Start date	31 January 2018
Primary completion	24 March 2018
Estimated completion	24 February 2019
Sites	1 location across Brazil

Drugs / interventions tested

• Yellow Fever vaccine (17D) — full drug profile →

Conditions studied

• Systemic Lupus — all drugs for Systemic Lupus →
• Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
• Spondyloarthritis — all drugs for Spondyloarthritis →
• Inflammatory Myopathy — all drugs for Inflammatory Myopathy →

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 2 to 60, any sex, with Systemic Lupus or Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunogenicity and safety of primary fractional-dose yellow fever vaccine in autoimmune rheumatic diseases.
   Tonacio AC, do Nascimento Pedrosa T, Borba EF, Aikawa NE, et al · · 2021 · cited 10× · PMID 34843469 · DOI 10.1371/journal.pntd.0010002
2. Fractional Dosing of Yellow Fever Live Attenuated 17D Vaccine: A Perspective.
   Hansen CA, Staples JE, Barrett ADT. · · 2023 · cited 5× · PMID 38023411 · DOI 10.2147/idr.s370013
3. Yellow fever vaccination in Brazil: Short-term safety and immunogenicity in juvenile autoimmune rheumatic diseases.
   Emi Aikawa N, Andrade Balbi V, Borba EF, Coracini Tonacio A, et al · · 2022 · cited 4× · PMID 34977552 · DOI 10.1016/j.jvacx.2021.100131