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. 2024 Dec 2;42(26):126394.
doi: 10.1016/j.vaccine.2024.126394. Epub 2024 Oct 4.

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

Natália S Hojo-Souza  1 , Júlia T de Castro  2 , Graziella G Rivelli  3 , Patrick O Azevedo  1 , Emiliano R Oliveira  4 , Lídia P Faustino  1 , Natália Salazar  3 , Flávia F Bagno  3 , Alex F Carvalho  3 , Bruna Rattis  5 , Karine L Lourenço  3 , Isabela P Gomes  3 , Bruna R D Assis  6 , Mariela Piccin  5 , Flávio G Fonseca  7 , Edison Durigon  8 , João S Silva  5 , Renan P de Souza  9 , Gisele A C Goulart  6 , Helton Santiago  10 , Ana Paula S Fernandes  6 , Santuza R Teixeira  10 , Ricardo T Gazzinelli  11
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Free article

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

Natália S Hojo-Souza et al. Vaccine. .
Free article

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.

Keywords: COVID-19; SARS-CoV-2; Vaccine.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ricardo Tostes Gazzinelli reports financial support was provided by Rede Virus from the Ministry of Science, Technology and Innovation. Ricardo Tostes Gazzinelli reports financial support was provided by National Council for Scientific and Technological Development. Ricardo Tostes Gazzinelli reports financial support was provided by National Institute of Science and Technology of Vaccines. Ricardo Tostes Gazzinelli reports financial support was provided by State of São Paulo Research Foundation. Ricardo Tostes Gazzinelli reports financial support was provided by Ministry of Education. Ricardo Tostes Gazzinelli reports financial support was provided by Oswaldo Cruz Foundation. Ricardo Tostes Gazzinelli reports financial support was provided by Belo Horizonte City Council. Ricardo Tostes Gazzinelli reports financial support was provided by Parliamentary Amendment of State and Federal Representatives from Minas Gerais. Ricardo Tostes Gazzinelli has patent #BR1020210095733 issued to Licensee. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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