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建立mRNA疫苗的体外效力与体内免疫原性之间的相关性。

Establishing correlation between in vitro potency and in vivo immunogenicity for mRNA vaccines.

作者信息

Sanyal Gautam

机构信息

Vaccine Analytics LLC, Kendall Park, NJ, USA.

出版信息

NPJ Vaccines. 2025 Jun 11;10(1):120. doi: 10.1038/s41541-025-01181-2.

DOI:10.1038/s41541-025-01181-2
PMID:40500281
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12159153/
Abstract

mRNA vaccines undergo intracellular translation to express the encoded protein antigen in a functionally intact form. To evaluate correlation between in vitro and in vivo measures of potency, mRNA vaccine samples with varying relative potencies can be created by gradual structural destabilization under stress including thermal stress. These samples can be tested in parallel for antigen expression in transfected cells and antigen-specific antibody induction and immune response in vaccinated animals.

摘要

信使核糖核酸（mRNA）疫苗在细胞内进行翻译，以功能完整的形式表达编码的蛋白质抗原。为了评估体外效力测量与体内效力测量之间的相关性，可以通过在包括热应激在内的应激条件下逐步破坏结构稳定性，制备出具有不同相对效力的mRNA疫苗样本。这些样本可以并行测试在转染细胞中的抗原表达，以及在接种疫苗的动物中诱导抗原特异性抗体和免疫反应的情况。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd52/12159153/19047985c163/41541_2025_1181_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd52/12159153/ef536c811bd9/41541_2025_1181_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd52/12159153/19047985c163/41541_2025_1181_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd52/12159153/ef536c811bd9/41541_2025_1181_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd52/12159153/19047985c163/41541_2025_1181_Fig2_HTML.jpg

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本文引用的文献

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2
Functionality and translation fidelity characterization of mRNA vaccines using platform based mass spectrometry detection.使用基于平台的质谱检测对mRNA疫苗的功能和翻译保真度进行表征。
NPJ Vaccines. 2025 Feb 23;10(1):38. doi: 10.1038/s41541-025-01082-4.
3
An in vitro CD8 T-cell priming assay enables epitope selection for hepatitis C virus vaccines.
一种体外 CD8 T 细胞启动测定法可用于丙型肝炎病毒疫苗的表位选择。
Vaccine. 2024 Sep 17;42(22):126032. doi: 10.1016/j.vaccine.2024.05.080. Epub 2024 Jul 3.
4
Long-term stability and immunogenicity of lipid nanoparticle COVID-19 mRNA vaccine is affected by particle size.脂质纳米颗粒 COVID-19 mRNA 疫苗的长期稳定性和免疫原性受颗粒大小的影响。
Hum Vaccin Immunother. 2024 Dec 31;20(1):2342592. doi: 10.1080/21645515.2024.2342592. Epub 2024 May 7.
5
Correlating Stability-Indicating Biochemical and Biophysical Characteristics with In Vitro Cell Potency in mRNA LNP Vaccine.将稳定性指示生化和生物物理特性与mRNA-LNP疫苗的体外细胞效力相关联。
Vaccines (Basel). 2024 Feb 7;12(2):169. doi: 10.3390/vaccines12020169.
6
Safety and Immunogenicity of an mRNA-Based RSV Vaccine Including a 12-Month Booster in a Phase 1 Clinical Trial in Healthy Older Adults.mRNA 编码 RSV 疫苗在健康老年人中进行的 1 期临床试验中包含 12 个月的加强针的安全性和免疫原性。
J Infect Dis. 2024 Sep 23;230(3):e647-e656. doi: 10.1093/infdis/jiae081.
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A quest for universal anti-SARS-CoV-2 T cell assay: systematic review, meta-analysis, and experimental validation.寻求通用的抗SARS-CoV-2 T细胞检测方法：系统评价、荟萃分析和实验验证。
NPJ Vaccines. 2024 Jan 2;9(1):3. doi: 10.1038/s41541-023-00794-9.
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