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Immunogenicity and safety of Coronavac vaccine in patients with autoimmune rheumatologic diseases: primary Sjörgren syndrome

Grant number: 21/08455-3
Support Opportunities:Scholarships in Brazil - Scientific Initiation
Start date: September 01, 2021
End date: February 28, 2023
Field of knowledge:Health Sciences - Medicine - Medical Clinics
Principal Investigator:Sandra Gofinet Pasoto
Grantee:Carolina Campagnoli Machado Freire Martins
Host Institution: Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
Associated research grant:15/03756-4 - Assessment of relevance of blood levels of drugs in the monitoring rheumatic autoimmune diseases: safety, effectiveness and adherence to therapy, AP.TEM

Abstract

The coronavirus disease pandemic 19 (COVID-19) progressed rapidly worldwide, reaching lethality of up to 20% in different regions (Garcia LF, 2020). More severe cases were observed in elderly patients with comorbidities, particularly in those with chronic cardiovascular or respiratory diseases, diabetes and hypertension (Garcia LF, 2020; Emmi G, 2020). Coronavirus infection with severe acute respiratory syndrome has raised particular concern in patients with autoimmune rheumatic diseases (ARD) (Garcia LF, 2020; Emmi G, 2020). Due to chronic inflammatory autoimmune dysregulation and regular use of immunosuppressive drugs (Fernandez-Ruiz R, 2020), these patients were considered at high risk of contracting SARS-CoV-2 infection and potentially worse prognosis (Fernandez-Ruiz R, 2020). Vaccine efficacy studies are needed to verify the immunogenicity of COVID-19 vaccine in immunosuppressed patients with rheumatologic disease. In addition, it is relevant to evaluate the safety of the vaccine in these populations, as well as the possibility of reactivation of the rheumatologic disease itself. Primary Sjögren's syndrome (SpS) is a systemic autoimmune rheumatic disease characterized mainly by the involvement of the salivary and lacrimal glands. This tissue damage leads to glandular dysfunction with decreased production of tears and saliva and, consequently, to symptoms of sicca syndrome. Other important features of SSp are b-cell hyperreactivity leading to the production of various circulating autoantibodies, particularly anti-Ro/SS-A and anti-La/SS-B antibodies, and progression to lymphoma in about 5% of cases (Mariette & Criswell, 2018).Our group participates in an international multicenter registry study on SSp and, as part of this study, the analysis of 51 patients with SSp and SARS-CoV-2 infection (Brito-Zerón et al., 2020) was recently published. Baseline comorbidities were a key risk factor for a more complicated COVID-19 picture in patients with SPS, with higher hospitalization rates and poor outcomes compared to patients without comorbidities (Brito-Zerón et al., 2020).

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
PASOTO, SANDRA GOFINET; HALPERN, ARI STIEL RADU; NORONHA GUEDES, LISSIANE KARINE; MEDEIROS RIBEIRO, ANA CRISTINA; FIGUEIREDO YUKI, EMILY NEVES; SCHAHIN SAAD, CARLA GONCALVES; ALMEIDA DA SILVA, CLOVIS ARTUR; KANDA KUPA, LEONARD DE VINCI; BETANCOURT VILLAMARIN, LORENA ELIZABETH; DE OLIVEIRA MARTINS, VICTOR ADRIANO; et al. Inactivated SARS-CoV-2 vaccine in primary Sjogren's syndrome: humoral response, safety, and effects on disease activity. CLINICAL RHEUMATOLOGY, v. 41, n. 7, p. 11-pg., . (20/11677-5, 20/09367-8, 19/17272-0, 17/14352-7, 15/03756-4, 18/09937-9, 21/08455-3)
ROSA M.R. PEREIRA; MARILIA A. DAGOSTIN; VALERIA F. CAPARBO; LUCAS P. SALES; SANDRA G. PASOTO; CLOVIS A. SILVA; EMILY F.N. YUKI; CARLA G.S. SAAD; ANA C. MEDEIROS-RIBEIRO; LEONARD V.K. KUPA; et al. Anti-SARS-CoV-2 inactivated vaccine in patients with ANCA-associated vasculitis: Immunogenicity, safety, antibody decay and the booster dose. Clinics, v. 78, . (19/17272-0, 15/03756-4, 20/09367-8, 21/08455-3, 18/09937-9)
CLOVIS ARTUR SILVA; LEONARD DE VINCI KANDA KUPA; ANA CRISTINA MEDEIROS-RIBEIRO; SANDRA GOFINET PASOTO; CARLA GONÇALVES SCHAHIN SAAD; EMILY FIGUEIREDO NEVES YUKI; JOAQUIM IVO VASQUES DANTAS LANDIM; VICTOR HUGO FERREIRA E LÉDA; LUISA SACCHI DE CAMARGO CORREIA; ARTUR FONSECA SARTORI; et al. Post-acute COVID-19 in three doses vaccinated autoimmune rheumatic diseases patients: frequency and pattern of this condition. ADVANCES IN RHEUMATOLOGY, v. 63, . (22/09565-0, 22/09566-6, 19/17272-0, 19/21173-7, 15/03756-4, 21/08455-3, 18/09937-9)