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Immunogenicity assessment of HPV16/18 vaccine using the glutathione S-transferase LI multiplex serology assay

机译：谷胱甘肽S-转移酶LI多重血清学分析评估HPV16 / 18疫苗的免疫原性

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The glutathione S-transferase (GST)-LI multiplex serology assay has favorable properties for use in clinical trials and epidemiologic studies, including low cost, high throughput capacity, and low serum volume requirement. Therefore, we evaluated the GST-L1 assay as a measure of HPV16/18 vaccine immunogenicity. Our study population included 65 women selected from the Costa Rica Vaccine Trial who received the bivalent HPV16/18 virus-like particle (VLP) vaccine at the recommended 0/1/6-month schedule. We tested replicate serum samples from months 0/1/12 (i.e., after 0/1/3 doses) by GST-L1 and 3 other commonly used serology assays, VLP-ELISA, SEAP-NA, and cLiA. We calculated the percentage of women seropositive by GST-LI by time point and HPV type (14 HPV types), and compared GST-L1 to other assays using Spearman rank correlation coefficients. After 1 vaccine dose, seropositivity by GST-LI was 40% each for HPV16 and HPV18, increasing to 100% and 98%, respectively, after 3 doses. Seropositivity after 3 doses ranged from 32% to 69% for HPV types 31/33/45, for which partial vaccine efficacy is reported, though increases also occurred for types with no evidence for cross-protection (e.g., HPV77). GST-L1 correlated best after 3 doses with VLP-ELISA (HPV16 and HPV18 each p = 0.72) and SEAP-NA (HPV16 p = 0.65, HPV18 p = 0.71) (all P < 0.001); correlation was lower with cLIA. The GST-L1 is suitable for evaluating HPV16/18 vaccine immunogenicity after 3 vaccine doses, although in contrast to other assays it may classify some samples as HPV16/18 seronegative. The assay's utility is limited for lower antibody levels such as after receipt of 1 dose.
机译：谷胱甘肽S-转移酶（GST）-LI多重血清学检测具有良好的特性，可用于临床试验和流行病学研究，包括低成本，高通量和低血清量要求。因此，我们评估了GST-L1分析作为HPV16 / 18疫苗免疫原性的量度。我们的研究人群包括从哥斯达黎加疫苗试验中选出的65名妇女，她们在建议的0/1/6个月时间表中接受了二价HPV16 / 18病毒样颗粒（VLP）疫苗。我们通过GST-L1和3种其他常用的血清学检测，VLP-ELISA，SEAP-NA和cLiA测试了0/1/12个月（即0/1/3剂量后）的重复血清样品。我们按时间点和HPV类型（14种HPV类型）计算了GST-LI血清阳性的女性百分比，并使用Spearman等级相关系数将GST-L1与其他检测方法进行了比较。接种1剂疫苗后，HPV16和HPV18的GST-LI血清阳性率为40％，三剂后分别提高到100％和98％。对于31/33/45型HPV，在3剂后3次血清反应呈阳性，报道了部分疫苗功效，尽管对于没有交叉保护证据的类型（例如HPV77）也有所增加。 3剂GST-L1与VLP-ELISA（HPV16和HPV18分别为p = 0.72）和SEAP-NA（HPV16 p = 0.65，HPV18 p = 0.71）相关性最高（所有P <0.001）;与cLIA的相关性较低。 GST-L1适用于3剂疫苗后评估HPV16 / 18疫苗的免疫原性，尽管与其他测定法相反，它可以将某些样品归类为HPV16 / 18血清阴性。该方法的实用性仅限于较低的抗体水平，例如在接受1剂后。

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