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Effect of Bruton tyrosine kinase inhibitor on efficacy of adjuvanted recombinant hepatitis B and zoster vaccines.

布鲁顿酪氨酸激酶抑制剂对佐剂重组乙型肝炎和带状疱疹疫苗疗效的影响。

  • 影响因子:0
  • DOI:10.1182/blood.2020008758
  • 作者列表:"Pleyer C","Ali MA","Cohen JI","Tian X","Soto S","Ahn IE","Gaglione EM","Nierman P","Marti GE","Hesdorffer C","Lotter J","Superata J","Wiestner A","Sun C
  • 发表时间:2021-01-14
Abstract

:Vaccinations are effective in preventing infections; however, it is unknown if patients with chronic lymphocytic leukemia (CLL) who are treatment naïve (TN) or receiving Bruton tyrosine kinase inhibitors (BTKi's) respond to novel adjuvanted vaccines. Understanding the effect of BTKi's on humoral immunity is timely because BTKi's are widely used and vaccination against coronavirus disease 2019 is urgently needed. In 2 open-label, single-arm clinical trials, we measured the effect of BTKi's on de novo immune response against recombinant hepatitis B vaccine (HepB-CpG) and recall response against recombinant zoster vaccine (RZV) in CLL patients who were TN or on BTKi. The primary end point was serologic response to HepB-CpG (anti-hepatitis B surface antibodies ≥10 mIU/mL) and RZV (≥fourfold increase in anti-glycoprotein E). The response rate to HepB-CpG was lower in patients on BTKi (3.8%; 95% confidence interval [CI], 0.7-18.9) than patients who were TN (28.1%; 95% CI, 15.6-45.4; P = .017). In contrast, the response rate to RZV did not differ significantly between the BTKi (41.5%; 95% CI, 27.8-56.6) and TN cohorts (59.1%; 95% CI, 38.7-76.7; P = .2). BTKi's were associated with a decreased de novo immune response following HepB-CpG, whereas recall immune response following RZV was not significantly affected by BTKi therapy. These trials were registered at www.clinicaltrials.gov as #NCT03685708 (Hep-CpG) and #NCT03702231 (RZV).

摘要

: 疫苗接种可有效预防感染; 然而,未接受治疗 (TN) 或接受布鲁顿酪氨酸激酶抑制剂 (BTKi) 的慢性淋巴细胞白血病 (CLL) 患者是否对新型佐剂疫苗有反应尚不清楚。了解BTKi对体液免疫的影响是及时的,因为BTKi广泛使用,急需针对冠状病毒疾病2019的疫苗接种。在2项开放标签的单臂临床试验中,我们测量了BTKi对TN或BTKi患者的重组乙型肝炎疫苗 (HepB-CpG) 从头免疫应答和重组带状疱疹疫苗 (RZV) 召回应答的影响。主要终点是对hepb-cpg (抗乙型肝炎表面抗体 ≥ 10 miu/mL) 和RZV (抗糖蛋白E增加 ≥ 4倍) 的血清学反应。接受BTKi治疗的患者对HepB-CpG的反应率 (3.8%; 95% 置信区间 [CI],0.7-18.9) 低于接受TN治疗的患者 (28.1%; 95% CI,15.6-45.4; P = .017)。相反,对RZV的反应率在BTKi (41.5%; 95% CI,27.8-56.6) 和TN队列 (59.1%; 95% CI,38.7-76.7; P = .2) 之间没有显著差异。BTKi与HepB-CpG后从头免疫应答降低有关,而RZV后回忆免疫应答不受BTKi治疗的显著影响。这些试验在www.clinicaltrials.gov注册为 # NCT03685708 (Hep-CpG) 和 # NCT03702231 (RZV)。

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