Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older.
Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older.
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DOI：
10.1093/infdis/jiy095
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发表时间：
2018-05-05
期刊：
影响因子：
--
通讯作者：
ZOE-50/70 Study Group
中科院分区：
文献类型：
--
作者：
Cunningham AL;Heineman TC;Lal H;Godeaux O;Chlibek R;Hwang SJ;McElhaney JE;Vesikari T;Andrews C;Choi WS;Esen M;Ikematsu H;Choma MK;Pauksens K;Ravault S;Salaun B;Schwarz TF;Smetana J;Abeele CV;Van den Steen P;Vastiau I;Weckx LY;Levin MJ;ZOE-50/70 Study Group
由水痘-带状疱疹病毒糖蛋白E(GE)和AS01B佐剂系统组成的带状疱疹亚单位疫苗(HZ/SU)在ZOE-50和ZOE-70试验中对带状疱疹具有良好的预防效果。我们公布了这些试验的免疫原性结果。受试者(ZOE-50：≥50；ZOE-70：≥70岁)接受两次剂量的HZ/SU或安慰剂，相隔2个月。检测体液免疫原性(n=3293)和细胞免疫原性(n=466)亚队列中抗GE抗体和CD4T细胞表达≥-2的4种活化标志物(CD42+)。接种疫苗后，97.8%的HZ/SU和2.0%的安慰剂接受者表现出体液反应。在服药后1个月和36个月，HZ/SU受者的几何平均抗GE抗体浓度分别是基线的39.1倍和8.3倍。在93.3%的HZ/SU和0%的安慰剂接受者中显示出GE特异性CD42+T细胞应答。在HZ/SU受者中，CD42+T细胞频率的中位数分别是基线的24.6倍(1个月)和7.9倍(36个月)，在36个月时，所有年龄组的≥仍然是基线的5.6倍。在所有年龄组中，表达所有4种激活标记的CD4T细胞的比例随着时间的推移而增加。大多数HZ/SU受者在接种疫苗后产生了持续3年的强烈免疫反应。NCT01165177；NCT01165229。由水痘-带状疱疹病毒糖蛋白E和AS01B佐剂系统组成的带状疱疹亚单位疫苗，在90%的受试者中刺激了特异性抗体和CD4T细胞反应，大多数持续了36个月的研究持续时间。
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. 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. 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. Most HZ/su recipients developed robust immune responses persisting for 3 years following vaccination. NCT01165177; NCT01165229. The herpes zoster subunit vaccine, consisting of varicella-zoster virus glycoprotein E and the AS01B Adjuvant System, stimulated specific antibody and CD4 T-cell responses in >90% of recipients which, in most, persisted for the 36-month duration of the study.
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