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.

通常通过全病毒（抗VZV）或基于糖蛋白的ELISA评估针对水痘带状疱疹病毒（VZV）的抗体反应。这项研究在一项III期试验（NCT02570126）中比较了接受23剂水痘疫苗接种的12至23个月大的婴儿中通过抗VZV糖蛋白E（anti-gE）和抗VZV ELISA定量分析测定的抗体浓度。最初用抗VZV ELISA检测的样品（每次接种前和接种后42天）用抗gE ELISA重新检测。在来自397名儿童的1138个样本中，有757个通过抗VZV（抗体浓度≥25mIU / mL）呈阳性，通过抗gE ELISA（≥97mIU / mL）呈阳性。有375个双负样本，只有11个差异样本。总体一致性为99.03％（95％置信区间：98.28-99.52； McNemar p值= 1）。752个双阳性样品的抗体几何平均浓度（抗gE /抗VZV）之间的比率总体为3.78，首次接种后为4.75和第二次接种后为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，用作对照。