Le Thi-Hong-Loc, Weng Tzu-Yu, Yen Hua, Chia Min-Yuan, Lee Min-Shi
National Institute of Infectious Diseases and Vaccinology, National Health Research Institutes, Zhunan, Miaoli, Taiwan.
Institute of Bioinformatics and Structural Biology, College of Life Sciences and Medicine, National Tsing Hua University, Hsinchu, Taiwan.
PLoS Negl Trop Dis. 2025 Jun 3;19(6):e0013127. doi: 10.1371/journal.pntd.0013127. eCollection 2025 Jun.
Enterovirus A71 (EV-A71) is one of the major causes of hand, foot, and mouth disease (HFMD), primarily affecting children under five. It can lead to neurological and cardiac complications, or even death, in some cases. Inactivated monovalent vaccines have been licensed in China and Taiwan; however, the stability of EV-A71 vaccines is often compromised by factors such as extreme temperatures or ultraviolet (UV) irradiation. Currently, no commercially available tools can assess the stability of EV-A71 throughout vaccine development. In this study, we report the development of a monoclonal antibody (mAb), NHRI2016-1, which can be used in in vitro immunoassays to evaluate EV-A71 vaccine potency and effectiveness. NHRI2016-1 exclusively recognizes effective EV-A71 antigens in in vitro potency assays. Similarly, rat experiment confirmed that effective vaccine antigens could induce neutralizing antibodies, while ineffective antigens could not. Thus, NHRI2016-1 shows potential for correlating in vitro potency with in vivo immunogenicity of EV-A71 vaccine antigens. These data suggest that NHRI2016-1 could be a promising tool for characterizing EV-A71 vaccines and monitoring vaccine potency.
肠道病毒A71（EV - A71）是手足口病（HFMD）的主要病因之一，主要影响五岁以下儿童。在某些情况下，它可导致神经和心脏并发症，甚至死亡。灭活单价疫苗已在中国和台湾获得许可；然而，EV - A71疫苗的稳定性常常受到极端温度或紫外线（UV）照射等因素的影响。目前，在整个疫苗研发过程中，没有可用于评估EV - A71稳定性的商业工具。在本研究中，我们报告了一种单克隆抗体（mAb）NHRI2016 - 1的研发情况，该抗体可用于体外免疫测定，以评估EV - A71疫苗的效力和有效性。在体外效力测定中，NHRI2016 - 1仅识别有效的EV - A71抗原。同样，大鼠实验证实，有效的疫苗抗原可诱导中和抗体，而无效抗原则不能。因此，NHRI2016 - 1显示出将EV - A71疫苗抗原的体外效力与体内免疫原性相关联的潜力。这些数据表明，NHRI2016 - 1可能是一种用于鉴定EV - A71疫苗和监测疫苗效力的有前景的工具。
