免疫应答对 50 岁及以上成人的重组糖蛋白 E 带状疱疹疫苗。
Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older.
机构信息
The Westmead Institute for Medical Research, University of Sydney, Australia.
GSK, King of Prussia, Pennsylvania.
出版信息
J Infect Dis. 2018 May 5;217(11):1750-1760. doi: 10.1093/infdis/jiy095.
BACKGROUND
The herpes zoster subunit vaccine (HZ/su), consisting of varicella-zoster virus glycoprotein E (gE) and AS01B Adjuvant System, was highly efficacious in preventing herpes zoster in the ZOE-50 and ZOE-70 trials. We present immunogenicity results from those trials.
METHODS
Participants (ZOE-50: ≥50; ZOE-70: ≥70 years of age) received 2 doses of HZ/su or placebo, 2 months apart. Serum anti-gE antibodies and CD4 T cells expressing ≥2 of 4 activation markers assessed (CD42+) after stimulation with gE-peptides were measured in subcohorts for humoral (n = 3293) and cell-mediated (n = 466) immunogenicity.
RESULTS
After vaccination, 97.8% of HZ/su and 2.0% of placebo recipients showed a humoral response. Geometric mean anti-gE antibody concentrations increased 39.1-fold and 8.3-fold over baseline in HZ/su recipients at 1 and 36 months post-dose 2, respectively. A gE-specific CD42+ T-cell response was shown in 93.3% of HZ/su and 0% of placebo recipients. Median CD42+ T-cell frequencies increased 24.6-fold (1 month) and 7.9-fold (36 months) over baseline in HZ/su recipients and remained ≥5.6-fold above baseline in all age groups at 36 months. The proportion of CD4 T cells expressing all 4 activation markers increased over time in all age groups.
CONCLUSIONS
Most HZ/su recipients developed robust immune responses persisting for 3 years following vaccination.
CLINICAL TRIALS REGISTRATION
NCT01165177; NCT01165229.
背景
带状疱疹亚单位疫苗（HZ/su）由水痘-带状疱疹病毒糖蛋白 E（gE）和 AS01B 佐剂系统组成，在 ZOE-50 和 ZOE-70 试验中高度有效预防带状疱疹。我们报告这些试验的免疫原性结果。
方法
参与者（ZOE-50：≥50 岁；ZOE-70：≥70 岁）接受 2 剂 HZ/su 或安慰剂，间隔 2 个月。在亚组中测量血清抗 gE 抗体和表达≥4 种激活标志物中的 2 种标志物（CD42+）的 CD4 T 细胞，这些标志物在 gE 肽刺激后进行评估，用于体液（n=3293）和细胞介导（n=466）免疫原性。
结果
接种疫苗后，97.8%的 HZ/su 和 2.0%的安慰剂接受者出现体液反应。在第 2 剂后 1 和 36 个月，HZ/su 接受者的几何平均抗 gE 抗体浓度分别比基线增加了 39.1 倍和 8.3 倍。在 HZ/su 接受者中显示了 gE 特异性 CD42+ T 细胞反应，而在安慰剂接受者中为 0%。在 HZ/su 接受者中，CD42+ T 细胞频率中位数在 1 个月时增加了 24.6 倍（基线），在 36 个月时增加了 7.9 倍（基线），在 36 个月时所有年龄组均保持基线以上≥5.6 倍。在所有年龄组中，表达所有 4 种激活标志物的 CD4 T 细胞比例随时间增加。
结论
大多数 HZ/su 接受者在接种疫苗后 3 年内产生了持久的免疫反应。
临床试验注册
NCT01165177；NCT01165229。
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