SpiN-Tec: A T cell-based recombinant vaccine that is safe, immunogenic, and shows high efficacy in experimental models challenged with SARS-CoV-2 variants of concern

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2024-10-04 DOI:10.1016/j.vaccine.2024.126394

Natália S. Hojo-Souza , Júlia T. de Castro , Graziella G. Rivelli , Patrick O. Azevedo , Emiliano R. Oliveira , Lídia P. Faustino , Natália Salazar , Flávia F. Bagno , Alex F. Carvalho , Bruna Rattis , Karine L. Lourenço , Isabela P. Gomes , Bruna R.D. Assis , Mariela Piccin , Flávio G. Fonseca , Edison Durigon , João S. Silva , Renan P. de Souza , Gisele A.C. Goulart , Helton Santiago , Ricardo T. Gazzinelli

{"title":"SpiN-Tec: A T cell-based recombinant vaccine that is safe, immunogenic, and shows high efficacy in experimental models challenged with SARS-CoV-2 variants of concern","authors":"Natália S. Hojo-Souza , Júlia T. de Castro , Graziella G. Rivelli , Patrick O. Azevedo , Emiliano R. Oliveira , Lídia P. Faustino , Natália Salazar , Flávia F. Bagno , Alex F. Carvalho , Bruna Rattis , Karine L. Lourenço , Isabela P. Gomes , Bruna R.D. Assis , Mariela Piccin , Flávio G. Fonseca , Edison Durigon , João S. Silva , Renan P. de Souza , Gisele A.C. Goulart , Helton Santiago , Ricardo T. Gazzinelli","doi":"10.1016/j.vaccine.2024.126394","DOIUrl":null,"url":null,"abstract":"<div><div>The emergence of new SARS-CoV-2 variants of concern associated with waning immunity induced by natural infection or vaccines currently in use suggests that the COVID-19 pandemic will become endemic. Investing in new booster vaccines using different platforms is a promising way to enhance protection and keep the disease under control. Here, we evaluated the immunogenicity, efficacy, and safety of the SpiN-Tec vaccine, based on a chimeric recombinant protein (SpiN) adjuvanted with CTVad1 (MF59-based adjuvant), aiming at boosting immunity against variants of concern of SARS-CoV-2. Immunization of K18-hACE-2 transgenic mice and hamsters induced high antibody titers and cellular immune response to the SpiN protein as well as to its components, RBD and N proteins. Importantly in a heterologous prime/boost protocol with a COVID-19 vaccine approved for emergency use (ChAdOx1), SpiN-Tec enhanced the level of circulation neutralizing antibodies (nAb). In addition to protection against the Wuhan isolate, protection against the Delta and Omicron variants was also observed as shown by reduced viral load and lung pathology. Toxicity and safety tests performed in rats demonstrated that the SpiN-Tec vaccine was safe and, based on these results, the SpiN-Tec phase I/II clinical trial was approved.</div></div>","PeriodicalId":23491,"journal":{"name":"Vaccine","volume":"42 26","pages":"Article 126394"},"PeriodicalIF":4.5000,"publicationDate":"2024-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Vaccine","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0264410X24010764","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

The emergence of new SARS-CoV-2 variants of concern associated with waning immunity induced by natural infection or vaccines currently in use suggests that the COVID-19 pandemic will become endemic. Investing in new booster vaccines using different platforms is a promising way to enhance protection and keep the disease under control. Here, we evaluated the immunogenicity, efficacy, and safety of the SpiN-Tec vaccine, based on a chimeric recombinant protein (SpiN) adjuvanted with CTVad1 (MF59-based adjuvant), aiming at boosting immunity against variants of concern of SARS-CoV-2. Immunization of K18-hACE-2 transgenic mice and hamsters induced high antibody titers and cellular immune response to the SpiN protein as well as to its components, RBD and N proteins. Importantly in a heterologous prime/boost protocol with a COVID-19 vaccine approved for emergency use (ChAdOx1), SpiN-Tec enhanced the level of circulation neutralizing antibodies (nAb). In addition to protection against the Wuhan isolate, protection against the Delta and Omicron variants was also observed as shown by reduced viral load and lung pathology. Toxicity and safety tests performed in rats demonstrated that the SpiN-Tec vaccine was safe and, based on these results, the SpiN-Tec phase I/II clinical trial was approved.

查看原文本刊更多论文

SpiN-Tec：一种以 T 细胞为基础的重组疫苗，它安全、免疫原性强，在受到 SARS-CoV-2 变异株挑战的实验模型中显示出很高的效力。

由于自然感染或目前使用的疫苗引起的免疫力下降，出现了令人担忧的新的 SARS-CoV-2 变种，这表明 COVID-19 大流行将成为地方病。投资使用不同平台的新强化疫苗是加强保护和控制疾病的有效途径。在这里，我们评估了 SpiN-Tec 疫苗的免疫原性、有效性和安全性，该疫苗基于嵌合重组蛋白 (SpiN) 与 CTVad1（基于 MF59 的佐剂）的佐剂，旨在增强对 SARS-CoV-2 关注变种的免疫力。对 K18-hACE-2 转基因小鼠和仓鼠进行免疫，可诱导出针对 SpiN 蛋白及其成分 RBD 和 N 蛋白的高抗体滴度和细胞免疫反应。重要的是，在与获准紧急使用的 COVID-19 疫苗（ChAdOx1）的异源原代/加强方案中，SpiN-Tec 提高了循环中和抗体（nAb）的水平。除了对武汉分离株有保护作用外，对德尔塔和奥米克龙变异株也有保护作用，这体现在病毒载量和肺部病理变化的减少上。在大鼠身上进行的毒性和安全性测试表明，SpiN-Tec 疫苗是安全的，基于这些结果，SpiN-Tec I/II 期临床试验获得批准。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

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.