Safety and immunogenicity of influenza A(H3N2) component vaccine in juvenile systemic lupus erythematosus

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Nadia Emi Aikawa ; Eduardo Ferreira Borba ^[2] ; Verena Andrade Balbi ^[3] ; Adriana Maluf Elias Sallum ^[4] ; Izabel Mantovani Buscatti ^[5] ; Lucia Maria Arruda Campos ^[6] ; Kátia Tomie Kozu ^[7] ; Cristiana Couto Garcia ; Artur Silva Vidal Capão ^[9] ; Adriana Coracini Tonacio de Proença ^[10] ; Elaine Pires Leon ^[11] ; Alberto José da Silva Duarte ^[12] ; Marta Heloisa Lopes ^[13] ; Clovis Artur Silva ; Eloisa Bonfá ^[15]

• Tipo de documento: Artigo Científico
• Fonte: ADVANCES IN RHEUMATOLOGY; v. 63, 2023-12-18.

Resumo

Abstract Introduction Seasonal influenza A (H3N2) virus is an important cause of morbidity and mortality in the last 50 years in population that is greater than the impact of H1N1. Data assessing immunogenicity and safety of this virus component in juvenile systemic lupus erythematosus (JSLE) is lacking in the literature. Objective To evaluate short-term immunogenicity and safety of influenza A/Singapore (H3N2) vaccine in JSLE. Methods 24 consecutive JSLE patients and 29 healthy controls (HC) were vaccinated with influenza A/Singapore/ INFIMH-16-0019/2016(H3N2)-like virus. Influenza A (H3N2) seroprotection (SP), seroconversion (SC), geometric mean titers (GMT), factor increase in GMT (FI-GMT) titers were assessed before and 4 weeks post-vaccination. Disease activity, therapies and adverse events (AE) were also evaluated. Results JSLE patients and controls were comparable in current age [14.5 (10.1–18.3) vs. 14 (9–18.4) years, p = 0.448] and female sex [21 (87.5%) vs. 19 (65.5%), p = 0.108]. Before vaccination, JSLE and HC had comparable SP rates [22 (91.7%) vs. 25 (86.2%), p = 0.678] and GMT titers [102.3 (95% CI 75.0–139.4) vs. 109.6 (95% CI 68.2–176.2), p = 0.231]. At D30, JSLE and HC had similar immune response, since no differences were observed in SP [24 (100%) vs. 28 (96.6%), p = 1.000)], SC [4 (16.7%) vs. 9 (31.0%), p = 0.338), GMT [162.3 (132.9–198.3) vs. 208.1 (150.5–287.8), p = 0.143] and factor increase in GMT [1.6 (1.2–2.1) vs. 1.9 (1.4–2.5), p = 0.574]. SLEDAI-2K scores [2 (0–17) vs. 2 (0–17), p = 0.765] and therapies remained stable throughout the study. Further analysis of possible factors influencing vaccine immune response among JSLE patients demonstrated similar GMT between patients with SLEDAI < 4 compared to SLEDAI ≥ 4 ( p = 0.713), as well as between patients with and without current use of prednisone ( p = 0.420), azathioprine ( p = 1.0), mycophenolate mofetil ( p = 0.185), and methotrexate ( p = 0.095). No serious AE were reported in both groups and most of them were asymptomatic (58.3% vs. 44.8%, p = 0.958). Local and systemic AE were alike in both groups ( p > 0.05). Conclusion This is the first study that identified adequate immune protection against H3N2-influenza strain with additional vaccine-induced increment of immune response and an adequate safety profile in JSLE. ( www.clinicaltrials.gov , NCT03540823). (AU)

• Processo FAPESP: 18/16162-3 - Campanha de vacinação de 2018 para febre amarela e influenza: segurança e imunogenicidade em pacientes com doenças autoimunes reumatológicas
• Beneficiário: Eduardo Ferreira Borba Neto
• Modalidade de apoio: Auxílio à Pesquisa - Regular
• Processo FAPESP: 10/10749-0 - Vacina anti-influenza H1N1/2009 em pacientes com doenças reumáticas autoimunes
• Beneficiário: Eloisa Silva Dutra de Oliveira Bonfá
• Modalidade de apoio: Auxílio à Pesquisa - Regular
• Processo FAPESP: 15/03756-4 - Avaliação da relevância dos níveis sanguíneos de drogas utilizadas em doenças autoimunes reumatológicas no acompanhamento da segurança, eficácia e aderência à terapêutica
• Beneficiário: Eloisa Silva Dutra de Oliveira Bonfá
• Modalidade de apoio: Auxílio à Pesquisa - Temático
• Processo FAPESP: 17/14352-7 - Avaliação da relevância dos níveis sanguíneos de drogas utilizadas em doenças autoimunes reumatológicas no acompanhamento da segurança, eficácia e aderência à terapêutica
• Beneficiário: Tatiana Do Nascimento Pedrosa
• Modalidade de apoio: Bolsas no Brasil - Pós-Doutorado