Data for: Potency testing for a recombinant protein vaccine early in clinical development: lessons from the Schistosoma mansoni Tetraspanin 2 vaccine

This dataset contains the potency data used for analysis in the paper “Potency testing for a recombinant protein vaccine early in clinical development: lessons from the Schistosoma mansoni Tetraspanin 2 vaccine” published in Vaccine X. Variable names and descriptions Lot #: The two manufactured lots (Aeras Lot# 11-69f-003 and WRAIR Lot #1975) of the recombinant Schistosoma mansoni (Sm) Tetraspanin-2 vaccine formulated on Alhydrogel (Sm-TSP-2/Al). Months Post-release: Potency timepoint in months post-release (0 = at release). Dose in μg: Immunization dose of Sm-TSP-2. Optical Density (OD): Optical Density measured at 492nm by indirect ELISA in serum samples diluted at 1:6000. Arbitrary Units (AU): Anti-Sm-TSP-2 IgG levels reported in Arbitrary Units (AU) determined from interpolating OD492nm for each sample onto a Global Standard Calibration Curve (GSCC). Reactivity Threshold (RT) in AU: The concentration of antibody expressed in AUs of IgG against Sm-TSP-2/Al, corresponding to the interpolated intersection of the lower asymptote of the upper 95% confidence limit with the lower 95% confidence limit of the GSCC. Limit of Quantification (LOQ) in AU: The concentration of antibody expressed in AUs of IgG against Sm-TSP-2/Al, corresponding to the interpolated intersection of the lower asymptote of the upper 95% confidence limit with the GSCC. Seropositivity: Whether the mouse seroconverted post-prime immunization (0= negative; 1= positive); Mice were considered seroconverted, or "responders", if the AU was above RT.本数据集包含发表于《Vaccine X》的论文《重组蛋白疫苗临床早期效力检测：来自曼氏血吸虫四跨膜蛋白2疫苗的经验教训》中用于分析的效力数据。 变量名称与说明 Lot #: 批次编号（Lot #）：两款制备批次（Aeras批次号11-69f-003与WRAIR批次号1975）的重组曼氏血吸虫（Schistosoma mansoni, Sm）四跨膜蛋白2疫苗，以Alhydrogel佐剂配制（Sm-TSP-2/Al）。 Months Post-release: 放行后月数（Months Post-release）：效力检测的放行后时间点（0代表疫苗放行当日）。 Dose in μg: 免疫剂量（Dose in μg）：Sm-TSP-2的免疫给药剂量，单位为微克。 Optical Density (OD): 光密度（Optical Density, OD）：采用间接酶联免疫吸附试验（indirect ELISA），以1:6000比例稀释血清样本后测得的492nm波长处光密度值。 Arbitrary Units (AU): 抗Sm-TSP-2 IgG水平以任意单位（Arbitrary Units, AU）报告，通过将各样本的OD492nm值代入全球标准校准曲线（Global Standard Calibration Curve, GSCC）插值计算得到。 Reactivity Threshold (RT) in AU: 反应阈值（Reactivity Threshold, RT）（单位AU）：针对Sm-TSP-2/Al的IgG抗体浓度，以AU为单位表示，对应全球标准校准曲线（GSCC）的上95%置信下限的下渐近线与GSCC下95%置信上限的插值交点。 Limit of Quantification (LOQ) in AU: 定量限（Limit of Quantification, LOQ）（单位AU）：针对Sm-TSP-2/Al的IgG抗体浓度，以AU为单位表示，对应全球标准校准曲线（GSCC）的上95%置信下限的下渐近线与GSCC的插值交点。 Seropositivity: 血清阳性率（Seropositivity）：小鼠在初免免疫后是否发生血清转换（0=阴性；1=阳性）；若样本的AU值高于反应阈值RT，则判定该小鼠为血清转换者，即“应答者”。