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基于CV0501 mRNA的奥密克戎新冠疫苗在小动物模型中的免疫原性和有效性评估

Assessment of Immunogenicity and Efficacy of CV0501 mRNA-Based Omicron COVID-19 Vaccination in Small Animal Models.

作者信息

Roth Nicole, Gergen Janina, Kovacikova Kristina, Mueller Stefan O, Ulrich Lorenz, Schön Jacob, Halwe Nico Joel, Fricke Charlie, Corleis Björn, Dorhoi Anca, Hoffmann Donata, Beer Martin, Maione Domenico, Petsch Benjamin, Rauch Susanne

机构信息

CureVac SE, 72076 Tübingen, Germany.

Institute of Diagnostic Virology, Friedrich Loeffler Institut, 17493 Griefswald-Insel Riems, Germany.

出版信息

Vaccines (Basel). 2023 Jan 31;11(2):318. doi: 10.3390/vaccines11020318.

DOI:10.3390/vaccines11020318
PMID:36851196
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9965737/
Abstract

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) Omicron and its subvariants (BA.2, BA.4, BA.5) represented the most commonly circulating variants of concern (VOC) in the coronavirus disease 2019 (COVID-19) pandemic in 2022. Despite high vaccination rates with approved SARS-CoV-2 vaccines encoding the ancestral spike (S) protein, these Omicron subvariants have collectively resulted in increased viral transmission and disease incidence. This necessitates the development and characterization of vaccines incorporating later emerging S proteins to enhance protection against VOC. In this context, bivalent vaccine formulations may induce broad protection against VOC and potential future SARS-CoV-2 variants. Here, we report preclinical data for a lipid nanoparticle (LNP)-formulated RNActive N1-methylpseudouridine (N1mΨ) modified mRNA vaccine (CV0501) based on our second-generation SARS-CoV-2 vaccine CV2CoV, encoding the S protein of Omicron BA.1. The immunogenicity of CV0501, alone or in combination with a corresponding vaccine encoding the ancestral S protein (ancestral N1mΨ), was first measured in dose-response and booster immunization studies performed in Wistar rats. Both monovalent CV0501 and bivalent CV0501/ancestral N1mΨ immunization induced robust neutralizing antibody titers against the BA.1, BA.2 and BA.5 Omicron subvariants, in addition to other SARS-CoV-2 variants in a booster immunization study. The protective efficacy of monovalent CV0501 against live SARS-CoV-2 BA.2 infection was then assessed in hamsters. Monovalent CV0501 significantly reduced SARS-CoV-2 BA.2 viral loads in the airways, demonstrating protection induced by CV0501 vaccination. CV0501 has now advanced into human Phase 1 clinical trials (ClinicalTrials.gov Identifier: NCT05477186).

摘要

严重急性呼吸综合征冠状病毒2（SARS-CoV-2）奥密克戎及其亚变体（BA.2、BA.4、BA.5）是2022年冠状病毒病2019（COVID-19）大流行中最常见的值得关注的变体（VOC）。尽管使用编码原始刺突（S）蛋白的获批SARS-CoV-2疫苗的接种率很高，但这些奥密克戎亚变体共同导致了病毒传播和疾病发病率的增加。这就需要研发并表征包含后来出现的S蛋白的疫苗，以增强对VOC的防护。在此背景下，二价疫苗配方可能诱导对VOC以及未来可能出现的SARS-CoV-2变体产生广泛防护。在此，我们报告一种基于我们的第二代SARS-CoV-2疫苗CV2CoV的脂质纳米颗粒（LNP）配方的RNActive N1-甲基假尿苷（N1mΨ）修饰的mRNA疫苗（CV0501）的临床前数据，该疫苗编码奥密克戎BA.1的S蛋白。首先在对Wistar大鼠进行的剂量反应和加强免疫研究中测量了CV0501单独或与编码原始S蛋白的相应疫苗（原始N1mΨ）联合使用时的免疫原性。在加强免疫研究中，单价CV0501和二价CV0501/原始N1mΨ免疫均诱导产生了针对BA.1、BA.2和BA.5奥密克戎亚变体以及其他SARS-CoV-2变体的强大中和抗体滴度。然后在仓鼠中评估了单价CV0501对活SARS-CoV-2 BA.2感染的保护效力。单价CV0501显著降低了气道中的SARS-CoV-2 BA.2病毒载量，证明了CV0501疫苗接种诱导的保护作用。CV0501现已进入人体1期临床试验（ClinicalTrials.gov标识符：NCT05477186）。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/656985d63bff/vaccines-11-00318-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/60fcca8736a7/vaccines-11-00318-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/4d44b3802bb3/vaccines-11-00318-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/479cd5f5a5a2/vaccines-11-00318-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/c6bf02a27e8a/vaccines-11-00318-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/7a0c2f3ae711/vaccines-11-00318-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/27cb007f7f84/vaccines-11-00318-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/656985d63bff/vaccines-11-00318-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/60fcca8736a7/vaccines-11-00318-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/4d44b3802bb3/vaccines-11-00318-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/479cd5f5a5a2/vaccines-11-00318-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/c6bf02a27e8a/vaccines-11-00318-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/7a0c2f3ae711/vaccines-11-00318-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/27cb007f7f84/vaccines-11-00318-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1ae5/9965737/656985d63bff/vaccines-11-00318-g007.jpg

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[1]
RNA Through Time: From the Origin of Life to Therapeutic Frontiers in Transcriptomics and Epitranscriptional Medicine.

Int J Mol Sci. 2025-5-22

[2]
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Hum Vaccin Immunother. 2024-12-31

[3]
Durable cross-protective neutralizing antibody responses elicited by lipid nanoparticle-formulated SARS-CoV-2 mRNA vaccines.

NPJ Vaccines. 2024-2-23

[4]
mRNA-based VP8* nanoparticle vaccines against rotavirus are highly immunogenic in rodents.

NPJ Vaccines. 2023-12-22

本文引用的文献

[1]
Alarming antibody evasion properties of rising SARS-CoV-2 BQ and XBB subvariants.

Cell. 2023-1-19

[2]
Exposure to BA.4/5 S protein drives neutralization of Omicron BA.1, BA.2, BA.2.12.1, and BA.4/5 in vaccine-experienced humans and mice.

Sci Immunol. 2022-12-23

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Acute and postacute sequelae associated with SARS-CoV-2 reinfection.

Nat Med. 2022-11

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Bivalent SARS-CoV-2 mRNA vaccines increase breadth of neutralization and protect against the BA.5 Omicron variant in mice.

Nat Med. 2023-1

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Optimised Non-Coding Regions of mRNA SARS-CoV-2 Vaccine CV2CoV Improves Homologous and Heterologous Neutralising Antibody Responses.

Vaccines (Basel). 2022-8-4

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ChAdOx1 nCoV-19 (AZD1222) or nCoV-19-Beta (AZD2816) protect Syrian hamsters against Beta Delta and Omicron variants.

Nat Commun. 2022-8-8

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Antibody Binding and Angiotensin-Converting Enzyme 2 Binding Inhibition Is Significantly Reduced for Both the BA.1 and BA.2 Omicron Variants.

Clin Infect Dis. 2023-2-8

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