甲型 H3N2 流感成分疫苗在青少年系统性红斑狼疮中的安全性和免疫原性。
Safety and immunogenicity of influenza A(H3N2) component vaccine in juvenile systemic lupus erythematosus.
机构信息
Pediatric Rheumatology Unit, Instituto da Criança e do Adolescente, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Av. Dr. Arnaldo, 455, 3Rd Floor, room 3190 - Cerqueira Cesar, São Paulo, SP, CEP 05403-010, Brazil.
Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
出版信息
Adv Rheumatol. 2023 Nov 28;63(1):55. doi: 10.1186/s42358-023-00339-7.
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).
简介
过去 50 年来，季节性甲型 H3N2 流感病毒是导致发病率和死亡率的一个重要原因，其影响大于 H1N1。关于幼年特发性关节炎（JSLE）患者体内甲型 H3N2 病毒成分的免疫原性和安全性的数据在文献中尚缺乏。
目的
评估甲型 H3N2 流感疫苗在 JSLE 中的短期免疫原性和安全性。
方法
连续纳入 24 例 JSLE 患者和 29 例健康对照（HC），接种甲型流感 A/Singapore（H3N2）类似病毒疫苗。在接种前和接种后 4 周评估甲型流感 A（H3N2）血清保护率（SP）、血清转化率（SC）、几何平均滴度（GMT）、GMT 增加倍数（FI-GMT）。还评估了疾病活动度、治疗和不良事件（AE）。
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]和女性比例[21（87.5%）比 19（65.5%），p=0.108]方面相似。接种前，JSLE 和 HC 的 SP 率相似[22（91.7%）比 25（86.2%），p=0.678]和 GMT 滴度相似[102.3（95%CI 75.0-139.4）比 109.6（95%CI 68.2-176.2），p=0.231]。在 D30 时，JSLE 和 HC 具有相似的免疫反应，因为 SP 无差异[24（100%）比 28（96.6%），p=1.000]、SC[4（16.7%）比 9（31.0%），p=0.338]、GMT[162.3（132.9-198.3）比 208.1（150.5-287.8），p=0.143]和 GMT 增加倍数[1.6（1.2-2.1）比 1.9（1.4-2.5），p=0.574]。SLEDAI-2K 评分[2（0-17）比 2（0-17），p=0.765]和治疗在整个研究过程中保持稳定。对 JSLE 患者中可能影响疫苗免疫反应的因素进行进一步分析表明，SLEDAI<4 与 SLEDAI≥4 患者的 GMT 无差异（p=0.713），以及泼尼松龙当前使用者与非使用者之间的 GMT 无差异（p=0.420）、硫唑嘌呤（p=1.0）、吗替麦考酚酯（p=0.185）和甲氨蝶呤（p=0.095）。两组均未报告严重不良事件，大多数为无症状（58.3%比 44.8%，p=0.958）。两组的局部和全身 AE 相似（p>0.05）。
结论
这是第一项在 JSLE 中确定了针对 H3N2 流感株的充分免疫保护，以及额外的疫苗诱导免疫反应增加和良好安全性的研究。（www.clinicaltrials.gov，NCT03540823）。
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