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

Author(s):Show less -

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]

• Document type: Journal article
• Source: ADVANCES IN RHEUMATOLOGY; v. 63, 2023-12-18.

Abstract

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)

• FAPESP's process: 18/16162-3 - Yellow fever and influenza 2018 vaccination campaign: safety and immunogenicity in patients with rheumatological autoimmune diseases
• Grantee: Eduardo Ferreira Borba Neto
• Support Opportunities: Regular Research Grants
• 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: 10/10749-0 - Anti-influenza H1N1/2009 vaccine in autoimmune rheumatic diseases patients
• Grantee: Eloisa Silva Dutra de Oliveira Bonfá
• Support Opportunities: Regular Research Grants
• FAPESP's process: 17/14352-7 - Assessment of relevance of blood levels of drugs in the monitoring rheumatic autoimmune diseases: safety, effectiveness and adherence to therapy
• Grantee: Tatiana Do Nascimento Pedrosa
• Support Opportunities: Scholarships in Brazil - Post-Doctoral