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Yellow Fever and Influenza 2018 vaccination campaign: safety and immunogenicity in patients with RHEUMATOLOGICAL autoimmune diseases

Grant number: 18/16162-3
Support type:Regular Research Grants
Duration: October 01, 2019 - September 30, 2021
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Eduardo Ferreira Borba Neto
Grantee:Eduardo Ferreira Borba Neto
Home Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
Assoc. researchers:Clovis Artur Almeida da Silva ; Eloisa Silva Dutra de Oliveira Bonfá ; Nádia Emi Aikawa ; Sandra Gofinet Pasoto

Abstract

The prognosis of autoimmune rheumatic diseases (ARD) has improved considerably with the advent of specific therapies, but infections are still a relevant cause of morbidity and mortality in this population. Immunization is therefore an important tool for infection prevention in this group of patients. The 2018 flu vaccination campaign was reinforced by the fact that in the US, there was a predominance of severe influenza A(H3N2) viruses infection that caused a significant number of hospitalizations and deaths. In that same year, the WHO included the State of São Paulo as an area of risk for yellow fever and the Societies of Specialists (Rheumatology, Immunization, Infectious Disease and Tropical Medicine) issued a technical note recommending vaccination to ARD patients who were under low degree of immunosuppression during the Vaccination Campaign. There are, however, no prospective controlled studies on immunogenicity, risk of adverse events and risk of activation of the disease by yellow fever and A/Singapore/INFIMH-16-0019/2016 A(H3N2)-like virus vaccines in patients with ARD. Thus, during the two campaigns carried out in the HC complex, patients with several autoimmune rheumatic diseases that were regularly followed in the HCFMUSP Rheumatology Unit and Pediatric Rheumatology Unit of the HCFMUSP Children's Institute and healthy controls were invited to participate in the study. For the Yellow Fever Campaign, we included healthy controls matched for sex/age and only patients with low immunosuppression [(rheumatoid arthritis (RA), spondyloarthritis, systemic lupus erythematosus (SLE), dermatomyositis (DM), mixed connective tissue disease, systemic vasculitis, systemic sclerosis (SS), primary Sjögren's syndrome (pSS), antiphospholipid syndrome (APS), juvenile idiopathic arthritis and juvenile SLE]. The subjects were evaluated clinically on the day of the vaccine (fractionated), 5, 10 and 30-45 days post-vaccination and at the same dates laboratory exams were collected for evaluation of adverse effects, viremia, immunogenicity and parameters of activity of each of diseases (patients only). For the annual influenza vaccination campaign 2018, with the inactivated and fragmented influenza vaccine [A/Michigan/45/2015 A(H1N1)pdm09-like virus, A/Singapore/INFIMH-16-0019/2016 A(H3N2)-like virus; B/ Phuket/3073/2013-like virus]. Healthy controls were matched for sex/age and patients with SLE (adult and juvenile) and pSS were included. All were evaluated clinically on the day of the vaccine and after 30-45 days post-vaccination and at the same dates laboratory exams were collected for evaluation of adverse effects, immunogenicity and parameters of activity of each disease (only patients). (AU)