A validated and standardized pseudotyped microneutralization assay as a safe and powerful tool to measure LASSA virus neutralising antibodies for vaccine development and comparison.

Q2 Pharmacology, Toxicology and Pharmaceutics

F1000Research Pub Date : 2024-10-14 eCollection Date: 2024-01-01 DOI:10.12688/f1000research.149578.2

Roberta Antonelli, Vittoria Forconi, Eleonora Molesti, Claudia Semplici, Pietro Piu, Maria Altamura, Francesca Dapporto, Nigel Temperton, Emanuele Montomoli, Alessandro Manenti

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引用次数: 0

Abstract

Background: Over the past few decades, World Health Organization (WHO) has made massive efforts to promote the development of a vaccine against Lassa virus (LASV), one of the top ten priority pathogens for research and development under the WHO R&D Blueprint for Emerging Infections. To date, several vaccines are at different stages of development. In this scenario, a validated and standardised assay to measure LASV neutralising antibodies is urgently needed for vaccine development and comparison.

Methods: The neutralisation assay remains the gold standard for determining antibody efficacy. Here we have proposed a safe and validated pseudotyped neutralisation assay for LASV, taking advantage of the development of the first WHO International Standard and Reference Panel for Anti-Lassa Fever (NIBSC code 21/332).

Results and conclusions: The proposed results demonstrate that the pseudotyped luciferase neutralisation assay is a specific serological test for the measurement of LASV neutralising antibodies without cross-reacting with standard sera specific for heterologous viral infections. In addition, the assay is accurate, precise, and linear according to criteria and statistical analyses defined and accepted by international guidelines.

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经过验证和标准化的假定型微中和试验，作为测量 LASSA 病毒中和抗体的安全而强大的工具，用于疫苗开发和比较。

背景：过去几十年来，世界卫生组织（WHO）一直在大力推动针对拉沙病毒（LASV）疫苗的开发，拉沙病毒是世界卫生组织新发传染病研发蓝图中十大优先研发病原体之一。迄今为止，有几种疫苗正处于不同的研发阶段。在这种情况下，迫切需要一种经过验证的标准化检测方法来测量 LASV 中和抗体，以便进行疫苗开发和比较：方法：中和试验仍是确定抗体效力的黄金标准。方法：中和试验仍是确定抗体效价的黄金标准。在此，我们利用世界卫生组织首个抗拉萨热国际标准和参考试剂盒（NIBSC 代码 21/332）的开发优势，提出了一种安全、有效的 LASV 伪型中和试验：拟议结果表明，伪型荧光素酶中和检测法是一种特异性血清学检测方法，可用于测量 LASV 中和抗体，不会与异源病毒感染的特异性标准血清发生交叉反应。此外，根据国际准则规定和认可的标准和统计分析，该检测方法准确、精确、线性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

F1000Research Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)

CiteScore

5.00

自引率

0.00%

发文量

1646

审稿时长

1 weeks

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