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(Reference retrieved automatically from SciELO through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

Anti-SARS-CoV-2 inactivated vaccine in patients with ANCA-associated vasculitis: Immunogenicity, safety, antibody decay and the booster dose

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Author(s):
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Rosa M.R. Pereira [1] ; Marilia A. Dagostin [2] ; Valeria F. Caparbo [3] ; Lucas P. Sales [4] ; Sandra G. Pasoto [5] ; Clovis A. Silva [6] ; Emily F.N. Yuki [7] ; Carla G.S. Saad [8] ; Ana C. Medeiros-Ribeiro [9] ; Leonard V.K. Kupa [10] ; Solange R.G. Fusco [11] ; Victor A.O. Martins [12] ; Carolina C.M.F. Martins [13] ; Carmen Valente Barbas [14] ; Samuel K. Shinjo [15] ; Nadia E. Aikawa ; Eloisa Bonfa [17]
Total Authors: 17
Affiliation:
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[1] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[2] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[3] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[4] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[5] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[6] Universidade de São Paulo. Faculdade de Medicina. Hospital das Clínicas - Brasil
[7] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[8] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[9] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[10] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[11] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[12] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[13] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[14] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[15] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
[17] Universidade de São Paulo (HCFMUSP). Faculdade de Medicina. Hospital das Clínicas - Brasil
Total Affiliations: 17
Document type: Journal article
Source: Clinics; v. 78, 2023-02-27.
Abstract

Abstract Objective: To evaluate inactivated CoronaVac prime vaccination, antibody decay, booster dose, and safety in ANCA-Associated Vasculitis (AAV) patients. Methods: Fifty-three AAV patients and 106 Controls (CG) received CoronaVac on days: D0 (first dose), D28(second dose), and D210 (booster dose, 32 AAV: 32 CG). The primary outcome was immunogenicity after the second vaccine dose (day 69) assessed by Seroconversion Rates (SC) of anti-SARS-CoV-2 S1/S2 IgG and Neutralizing Antibodies (NAb). Secondary outcomes were safety, immunogenicity (D28/D240), 6-months antibody decay (D210) and the booster dose response (D240). Results: At D69 SC (65.1% vs. 96.8%, p = 0.0001), GMT (21.3 UA/mL vs. 67.7 UA/mL, p < 0.001) and NAb- positivity (53.7% vs. 80.6%, p = 0.001) were moderate but lower in naïve-AAV patients than CG. Patients without SC used more often IS (93.3% vs. 53.3%, p = 0.015), mycophenolate mofetil (20% vs. 0%, p = 0.037) and prednisone (60.0% vs. 28.6%, p = 0.057) than seroconverted. NAb negativity in AAV patients was associated with prednisone treatment (57.9% vs. 18.2%, p = 0.015) and IS (84.2% vs. 55.0%, p = 0.046). Logistic regression analysis models showed that only prednisone was associated with lower seroconversion (OR = 0.2, 0,95% CI 0.05–0.86, p = 0.030) and with lower NAb positivity (OR = 0.2, 0,95% CI 0.05–0.88, p = 0.034). After six months (D69–D210) a decrease in IgG positivity occurred in 32 AAV patients (15.7%, p = 0.074) and 32 CG (18.7%, p = 0.041). For the NAb positivity, the 6-month decrease was not significant (p = 0.114) whereas a major reduction occurred for CG (p < 0.001). A booster dose (D240) resulted in an increment in IgG-positivity (21.9%, p = 0.023) and NAb-positivity (34.4%, p = 0.006) in AAV patients. No moderate/severe adverse events attributable to the vaccine were observed. Conclusion: This study provides novel data on the excellent safety and moderate immunogenicity of CoronaVac in AAV patients. A six-month mild antibody waning was observed with a good response to the booster dose, although levels remained lower than CG (CoronavRheum-NCT04754698). (AU)

FAPESP's process: 20/09367-8 - Analysis of blood hydroxychlorochine levels in patients with primary Sjogren Syndrome and possible correlation with the disease activity
Grantee:Lorena Elizabeth Betancourt Villamarín
Support Opportunities: Scholarships in Brazil - Doctorate (Direct)
FAPESP's process: 15/03756-4 - Assessment of relevance of blood levels of drugs in the monitoring rheumatic autoimmune diseases: safety, effectiveness and adherence to therapy
Grantee:Eloisa Silva Dutra de Oliveira Bonfá
Support Opportunities: Research Projects - Thematic Grants
FAPESP's process: 18/09937-9 - Analysis of the immune profile of saliva and serum of patients with primary Sjogren's Syndrome
Grantee:Victor Adriano de Oliveira Martins
Support Opportunities: Scholarships in Brazil - Doctorate (Direct)
FAPESP's process: 19/17272-0 - Relevance of monitoring blood levels compared to salivar levels of drugs used in rheumatic autoimmune diseases: adherence and understanding the possible underlying mechanisms involved in effectiveness and in adverse effects
Grantee:Leonard de Vinci Kanda Kupa
Support Opportunities: Scholarships in Brazil - Post-Doctoral
FAPESP's process: 21/08455-3 - Immunogenicity and safety of Coronavac vaccine in patients with autoimmune rheumatologic diseases: primary Sjörgren syndrome
Grantee:Carolina Campagnoli Machado Freire Martins
Support Opportunities: Scholarships in Brazil - Scientific Initiation