Novel liquid-phase blocking ELISA using single-domain antibody M8 and virus-like particles for in-vitro potency assessment of foot-and-mouth disease virus-like particle vaccine

IF 4.5 3区 医学 Q2 IMMUNOLOGY
Haozhou Li , Aldo Dekker , Yaya Zhang , Yun Zhang , Michiel Harmsen , Wim van der Poel , Huichen Guo , Shiqi Sun
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引用次数: 0

Abstract

Potency tests for inactivated foot-and-mouth disease (FMD) vaccines involve either in vivo challenge trials in target animals or in vitro tests. However, evaluating potency of FMD virus-like particle (VLP) vaccines currently lack in vitro tools. We developed a liquid-phase blocking ELISA (LPBE) using a broadly neutralizing single-domain antibody (M8) and FMD VLPs to assess antibody titers in animals vaccinated with FMD serotype O VLPs. We utilized 505 negative sera and 32 sera of pigs infected or vaccinated with other viruses than FMDV to validate the M8 LPBE detection limit. The M8 LPBE was compared to virus neutralizing test and conventional LPBE using 338 sera from PD50 potency tests in cattle and pigs. The results were analyzed using logistic models. The M8 LPBE showed superior correlation with protection, with an average titer of 1.7 log10 corresponding to a potency of 3 PD50/dose.
采用单域抗体M8和病毒样颗粒的新型液相阻断ELISA法评估口蹄疫病毒样颗粒疫苗的体外效价
灭活口蹄疫(FMD)疫苗的效力测试包括在靶动物体内的攻毒试验或体外试验。然而,评估口蹄疫病毒样颗粒(VLP)疫苗效力目前缺乏体外工具。我们开发了一种液相阻断ELISA (LPBE),使用广泛中和的单域抗体(M8)和口蹄疫VLPs来评估接种口蹄疫血清型O VLPs的动物的抗体滴度。我们用505例阴性血清和32例感染或接种了FMDV以外其他病毒的猪血清验证了M8 LPBE的检出限。利用牛和猪的PD50效价338血清,将M8 LPBE与病毒中和试验和常规LPBE进行了比较。使用logistic模型对结果进行分析。M8 LPBE显示出较好的保护相关性,平均滴度为1.7 log10,对应于3pd50 /剂量的效价。
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来源期刊
Vaccine
Vaccine 医学-免疫学
CiteScore
8.70
自引率
5.50%
发文量
992
审稿时长
131 days
期刊介绍: Vaccine is unique in publishing the highest quality science across all disciplines relevant to the field of vaccinology - all original article submissions across basic and clinical research, vaccine manufacturing, history, public policy, behavioral science and ethics, social sciences, safety, and many other related areas are welcomed. The submission categories as given in the Guide for Authors indicate where we receive the most papers. Papers outside these major areas are also welcome and authors are encouraged to contact us with specific questions.
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