Hojo-Souza Natália S, de Castro Júlia T, Rivelli Graziella G, Azevedo Patrick O, Oliveira Emiliano R, Faustino Lídia P, Salazar Natália, Bagno Flávia F, Carvalho Alex F, Rattis Bruna, Lourenço Karine L, Gomes Isabela P, Assis Bruna R D, Piccin Mariela, Fonseca Flávio G, Durigon Edison, Silva João S, de Souza Renan P, Goulart Gisele A C, Santiago Helton, Fernandes Ana Paula S, Teixeira Santuza R, Gazzinelli Ricardo T
Centro de Tecnologia de Vacinas, Universidade Federal de Minas Gerais, Brazil; Instituto René Rachou, Fundação Oswaldo Cruz-Minas, Brazil.
Centro de Tecnologia de Vacinas, Universidade Federal de Minas Gerais, Brazil; Instituto René Rachou, Fundação Oswaldo Cruz-Minas, Brazil; Plataforma Bi-Institucional de Pesquisa em Medicina Translacional, Fundação Oswaldo Cruz, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, Brazil.
Vaccine. 2024 Dec 2;42(26):126394. doi: 10.1016/j.vaccine.2024.126394. Epub 2024 Oct 4.
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.
与自然感染或现有疫苗诱导的免疫力下降相关的新型严重急性呼吸综合征冠状病毒2（SARS-CoV-2）变异株的出现表明，冠状病毒病（COVID-19）大流行将成为地方性流行病。投资研发使用不同平台的新型加强疫苗是增强保护并控制该疾病的一种有前景的方法。在此，我们评估了基于嵌合重组蛋白（SpiN）并佐以CTVad1（基于MF59的佐剂）的SpiN-Tec疫苗的免疫原性、效力和安全性，旨在增强针对SARS-CoV-2变异株的免疫力。对K18-hACE-2转基因小鼠和仓鼠进行免疫接种后，诱导产生了针对SpiN蛋白及其组分受体结合域（RBD）和核衣壳（N）蛋白的高抗体滴度和细胞免疫反应。重要的是，在与一种获批用于紧急使用的COVID-19疫苗（ChAdOx1）进行的异源初免/加强方案中，SpiN-Tec提高了循环中和抗体（nAb）水平。除了对武汉毒株有保护作用外，还观察到对德尔塔和奥密克戎变异株的保护作用，表现为病毒载量降低和肺部病理变化减轻。在大鼠中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的I/II期临床试验获得批准。
