GSK, Rue de l'Institut 89, 1330 Rixensart, Belgium.
GSK, Av. Fleming 20, 1300 Wavre, Belgium.
Vaccine. 2020 Apr 9;38(17):3300-3304. doi: 10.1016/j.vaccine.2020.03.009. Epub 2020 Mar 14.
Antibody response against varicella-zoster virus (VZV) is frequently assessed by whole-virus- (anti-VZV) or glycoprotein-based ELISAs. This study compared antibody concentrations measured by an assay quantifying anti-VZV glycoprotein E (anti-gE) and anti-VZV ELISA in 12-23-month-olds, receiving two varicella vaccine doses in a phase III trial (NCT02570126). Samples (pre- and 42 days post-each vaccination) initially tested with anti-VZV ELISA were re-tested with anti-gE ELISA. Of 1138 samples from 397 children, 757 were positive by anti-VZV (antibody concentration ≥25 mIU/mL) and 758 by anti-gE ELISA (≥97 mIU/mL). There were 375 double-negative and only 11 discrepant samples. The overall agreement was 99.03% (95% confidence interval: 98.28-99.52; McNemar p-value = 1). The ratio between antibody geometric mean concentrations (anti-gE/anti-VZV) for the 752 double-positive samples was 3.78 overall, 4.75 post-first, and 3.01 post-second vaccination. The anti-gE ELISA is a valid alternative for trials assessing antibody response to new varicella vaccines versus established ones, used as control.
抗体对水痘带状疱疹病毒（VZV）的反应通常通过全病毒（抗 VZV）或糖蛋白为基础的 ELISA 进行评估。本研究比较了在一项 III 期试验（NCT02570126）中接受两剂水痘疫苗的 12-23 个月大婴儿中，通过定量抗 VZV 糖蛋白 E（抗-gE）和抗 VZV ELISA 测量的抗体浓度。最初用抗 VZV ELISA 测试的样本（每次接种前和 42 天后）用抗-gE ELISA 重新测试。在 397 名儿童的 1138 个样本中，有 757 个样本通过抗 VZV ELISA 呈阳性（抗体浓度≥25 mIU/mL），758 个样本通过抗-gE ELISA 呈阳性（≥97 mIU/mL）。有 375 个双阴性和只有 11 个不一致的样本。总体一致性为 99.03%（95%置信区间：98.28-99.52；McNemar p 值=1）。对于 752 个双阳性样本，抗体几何平均浓度（抗-gE/抗-VZV）的比值总体为 3.78，第一次接种后为 4.75，第二次接种后为 3.01。抗-gE ELISA 是评估新水痘疫苗与已建立疫苗的抗体反应的有效替代方法，可用作对照。
