Centre for the Evaluation of Vaccination (CEV), Vaccine & Infectious Disease Institute (VAXINFECTIO), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Multidisciplinary Breast Clinic, Gynecological Oncology Unit, Department of Obstetrics and Gynecology. Antwerp University Hospital (UZA) (Belgium), Molecular Imaging, Pathology, Radiotherapy, and Oncology (MIPRO), Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
J Med Virol. 2023 Oct;95(10):e29133. doi: 10.1002/jmv.29133.
Assessment of humoral immune responses following human papillomavirus (HPV) vaccination currently relies on invasive blood sampling. This longitudinal cohort study explores the usability of first-void urine as a noninvasive alternative sample for antibody detection. In this study, 58 women receiving three doses of the 9vHPV vaccine within a Gardasil9 (9vHPV) Phase III randomized controlled trial were included. Participants provided paired first-void urine and blood samples before vaccination (M0), 1 month after the third dose (M7), and ~3 years after the third dose (M43). Type-specific antibody responses to the 9vHPV types were analyzed in 174 first-void urine and 172 serum samples using a virus-like particle-based IgG multiplex enzyme-linked immunosorbent assay. Additionally, total human IgG concentrations were determined using the BioPlex assay. At M7, 1 month after complete 9vHPV vaccination, 95%-100% of first-void urine and 100% of serum samples had detectable concentrations, varying by HPV type. At M43, 84%-100% of first-void urine and 98%-100% of serum samples had HPV-specific antibody concentrations. Results show significant Spearman rank correlations between type-specific HPV-antibody concentrations for paired first-void urine and serum at all time points. This study confirms the potential feasibility of utilizing first-void urine as a noninvasive immunological sample within HPV vaccine trials.
目前，评估人类乳头瘤病毒（HPV）疫苗接种后的体液免疫反应依赖于有创的血液采样。本纵向队列研究探讨了将首次排空尿液作为一种用于抗体检测的非侵入性替代样本的可用性。在这项研究中，纳入了 58 名在 Gardasil9（9vHPV）三期随机对照试验中接受三剂 9vHPV 疫苗的女性。参与者在接种前（M0）、第三次接种后 1 个月（M7）和第三次接种后约 3 年（M43）时提供了配对的首次排空尿液和血液样本。使用基于病毒样颗粒的 IgG 多重酶联免疫吸附测定法，对 174 份首次排空尿液和 172 份血清样本中针对 9vHPV 型的特异性抗体反应进行了分析。此外，使用 BioPlex 检测法测定了总人 IgG 浓度。在 M7 时，即完全接种 9vHPV 疫苗后 1 个月，95%-100%的首次排空尿液和 100%的血清样本可检测到浓度，因 HPV 类型而异。在 M43 时，84%-100%的首次排空尿液和 98%-100%的血清样本具有 HPV 特异性抗体浓度。结果表明，在所有时间点，配对的首次排空尿液和血清中针对特定 HPV 抗体浓度之间均存在显著的 Spearman 等级相关。这项研究证实了在 HPV 疫苗试验中，将首次排空尿液作为非侵入性免疫样本的潜在可行性。
