Nadia Emi Aikawa, Eduardo Ferreira Borba, Verena Andrade Balbi, Adriana Maluf Elias Sallum, Izabel Mantovani Buscatti, Lucia Maria Arruda Campos, Kátia Tomie Kozu, Cristiana Couto Garcia, Artur Silva Vidal Capão, Adriana Coracini Tonacio de Proença, Elaine Pires Leon, Alberto José da Silva Duarte, Marta Heloisa Lopes, Clovis Artur Silva, Eloisa Bonfá
{"title":"甲型流感(H3N2)成分疫苗对幼年系统性红斑狼疮的安全性和免疫原性。","authors":"Nadia Emi Aikawa, Eduardo Ferreira Borba, Verena Andrade Balbi, Adriana Maluf Elias Sallum, Izabel Mantovani Buscatti, Lucia Maria Arruda Campos, Kátia Tomie Kozu, Cristiana Couto Garcia, Artur Silva Vidal Capão, Adriana Coracini Tonacio de Proença, Elaine Pires Leon, Alberto José da Silva Duarte, Marta Heloisa Lopes, Clovis Artur Silva, Eloisa Bonfá","doi":"10.1186/s42358-023-00339-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Objective: </strong>To evaluate short-term immunogenicity and safety of influenza A/Singapore (H3N2) vaccine in JSLE.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p><p><strong>Clinicaltrials: </strong>gov , NCT03540823).</p>","PeriodicalId":2,"journal":{"name":"ACS Applied Bio Materials","volume":null,"pages":null},"PeriodicalIF":4.6000,"publicationDate":"2023-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and immunogenicity of influenza A(H3N2) component vaccine in juvenile systemic lupus erythematosus.\",\"authors\":\"Nadia Emi Aikawa, Eduardo Ferreira Borba, Verena Andrade Balbi, Adriana Maluf Elias Sallum, Izabel Mantovani Buscatti, Lucia Maria Arruda Campos, Kátia Tomie Kozu, Cristiana Couto Garcia, Artur Silva Vidal Capão, Adriana Coracini Tonacio de Proença, Elaine Pires Leon, Alberto José da Silva Duarte, Marta Heloisa Lopes, Clovis Artur Silva, Eloisa Bonfá\",\"doi\":\"10.1186/s42358-023-00339-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Objective: </strong>To evaluate short-term immunogenicity and safety of influenza A/Singapore (H3N2) vaccine in JSLE.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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). 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引用次数: 0
摘要
简介:季节性甲型流感(H3N2)病毒是过去50年人口发病率和死亡率的重要原因，其影响大于H1N1。文献中缺乏评估该病毒成分在幼年系统性红斑狼疮(JSLE)中的免疫原性和安全性的数据。目的:评价甲型流感/新加坡(H3N2)疫苗治疗JSLE的短期免疫原性和安全性。方法:连续24例JSLE患者和29例健康对照(HC)接种甲型流感/新加坡/INFIMH-16-0019/2016(H3N2)样病毒。在接种前和接种后4周评估甲型流感(H3N2)血清保护(SP)、血清转化(SC)、几何平均滴度(GMT)、GMT因子升高(FI-GMT)滴度。疾病活动性、治疗和不良事件(AE)也进行了评估。结果:JSLE患者和对照组在当前年龄[14.5(10.1-18.3)比14(9-18.4)岁，p = 0.448]和女性[21(87.5%)比19 (65.5%)，p = 0.108]具有可比性。接种疫苗前，JSLE和HC的SP率[22(91.7%)比25 (86.2%)，p = 0.678]和GMT滴度[102.3 (95% CI 75.0-139.4)比109.6 (95% CI 68.2-176.2)， p = 0.231]相当。在D30时，JSLE和HC具有相似的免疫应答，因为SP[24(100%)对28 (96.6%)，p = 1.000)]， SC[4(16.7%)对9 (31.0%)，p = 0.338)， GMT[162.3(132.9-198.3)对208.1 (150.5-287.8)，p = 0.143]和GMT因子增加[1.6(1.2-2.1)对1.9 (1.4-2.5)，p = 0.574]没有差异。SLEDAI-2K评分[2 (0-17)vs. 2 (0-17)， p = 0.765]和治疗在整个研究过程中保持稳定。进一步分析影响JSLE患者疫苗免疫应答的可能因素表明，SLEDAI患者之间的GMT相似(0.05)。结论:这是第一个在JSLE中发现对h3n2流感毒株有足够的免疫保护，额外的疫苗诱导的免疫反应增加和足够的安全性的研究。(www.Clinicaltrials: gov, NCT03540823)。
Safety and immunogenicity of influenza A(H3N2) component vaccine in juvenile systemic lupus erythematosus.
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.
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