Schuerman L, Wysocki J, Tejedor J C, Knuf M, Kim K-H, Poolman J
GlaxoSmithKline Biologicals, Avenue Fleming 20 (W23), 1300 Wavre, Belgium.
Clin Vaccine Immunol. 2011 Dec;18(12):2161-7. doi: 10.1128/CVI.05313-11. Epub 2011 Oct 12.
We compared the abilities of two serological readouts, antipolysaccharide IgG antibody concentrations and opsonophagocytic activity (OPA) titers, to predict the clinical effectiveness of the 7-valent pneumococcal conjugate vaccine (7vCRM) against invasive pneumococcal disease (IPD). We also assessed the accuracy of the previously established thresholds for GlaxoSmithKline's enzyme-linked immunosorbent assay with 22F adsorption (22F-ELISA) (≥0.2 μg/ml) and OPA assay (titer, ≥8) in predicting effectiveness. We showed that following a 3-dose 7vCRM primary vaccination, the serological response rates as determined using thresholds of ≥0.2 μg/ml IgG and an OPA titer of ≥8 corresponded well with overall effectiveness against IPD. In addition, the OPA assay seemed to better predict serotype-specific effectiveness than enzyme-linked immunoassay. Finally, when applied to post-dose-2 immune responses, both thresholds also corresponded well with the overall IPD effectiveness following a 2-dose 7vCRM primary vaccination. These results support the importance of the OPA assay in evaluating immune responses to pneumococcal conjugate vaccines.
我们比较了两种血清学检测指标——抗多糖IgG抗体浓度和调理吞噬活性（OPA）滴度，以预测7价肺炎球菌结合疫苗（7vCRM）预防侵袭性肺炎球菌疾病（IPD）的临床效果。我们还评估了先前确定的葛兰素史克22F吸附酶联免疫吸附测定（22F-ELISA）（≥0.2μg/ml）和OPA测定（滴度≥8）的阈值在预测效果方面的准确性。我们发现，在进行3剂7vCRM基础免疫接种后，使用IgG≥0.2μg/ml和OPA滴度≥8的阈值确定的血清学应答率与预防IPD的总体效果高度相符。此外，与酶联免疫测定相比，OPA测定似乎能更好地预测血清型特异性效果。最后，当应用于第2剂接种后的免疫应答时，这两个阈值也与2剂7vCRM基础免疫接种后预防IPD的总体效果高度相符。这些结果支持了OPA测定在评估肺炎球菌结合疫苗免疫应答中的重要性。
