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
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...
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| Veröffentlicht in: | Vaccine 2024-12, Vol.42 (26), p.126394, Article 126394 |
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| creator | 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. |
| description | 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. |
| doi_str_mv | 10.1016/j.vaccine.2024.126394 |
| format | Article |
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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.</description><identifier>ISSN: 0264-410X</identifier><identifier>ISSN: 1873-2518</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2024.126394</identifier><identifier>PMID: 39368129</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Adjuvants ; Adjuvants, Vaccine ; Animals ; Antibodies ; Antibodies, Neutralizing - blood ; Antibodies, Neutralizing - immunology ; Antibodies, Viral - blood ; Antibodies, Viral - immunology ; Antigens ; Cell culture ; cell-mediated immunity ; clinical trials ; COVID-19 ; COVID-19 - immunology ; COVID-19 - prevention & control ; COVID-19 infection ; COVID-19 vaccines ; COVID-19 Vaccines - immunology ; Cricetinae ; Disease control ; Disease Models, Animal ; E coli ; Effectiveness ; Emergency response ; Enzymes ; Female ; genetically modified organisms ; Hamsters ; Humans ; Immune response ; Immune response (cell-mediated) ; Immune system ; Immunity ; Immunity (Disease) ; Immunization ; Immunization, Secondary ; Immunogenicity ; Immunogenicity, Vaccine ; Infections ; Laboratory animals ; lungs ; Lymphocytes ; Lymphocytes T ; Mice ; Mice, Transgenic ; Pandemics ; Proteins ; Rats ; recombinant proteins ; recombinant vaccines ; SARS-CoV-2 ; SARS-CoV-2 - immunology ; Severe acute respiratory syndrome coronavirus 2 ; Spike Glycoprotein, Coronavirus - genetics ; Spike Glycoprotein, Coronavirus - immunology ; T-Lymphocytes - immunology ; Toxicity ; Transgenic mice ; Vaccine ; Vaccine Efficacy ; Vaccines ; Vaccines, Synthetic - administration & dosage ; Vaccines, Synthetic - immunology ; Viral diseases ; viral load</subject><ispartof>Vaccine, 2024-12, Vol.42 (26), p.126394, Article 126394</ispartof><rights>2024 The Authors</rights><rights>Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.</rights><rights>2024. The Authors</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c351t-2bc8f711cf209ce250339a53549a7e141092779595009fc3a2ece671df2cfd3e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.vaccine.2024.126394$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,778,782,3539,27907,27908,45978</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39368129$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hojo-Souza, Natália S.</creatorcontrib><creatorcontrib>de Castro, Júlia T.</creatorcontrib><creatorcontrib>Rivelli, Graziella G.</creatorcontrib><creatorcontrib>Azevedo, Patrick O.</creatorcontrib><creatorcontrib>Oliveira, Emiliano R.</creatorcontrib><creatorcontrib>Faustino, Lídia P.</creatorcontrib><creatorcontrib>Salazar, Natália</creatorcontrib><creatorcontrib>Bagno, Flávia F.</creatorcontrib><creatorcontrib>Carvalho, Alex F.</creatorcontrib><creatorcontrib>Rattis, Bruna</creatorcontrib><creatorcontrib>Lourenço, Karine L.</creatorcontrib><creatorcontrib>Gomes, Isabela P.</creatorcontrib><creatorcontrib>Assis, Bruna R.D.</creatorcontrib><creatorcontrib>Piccin, Mariela</creatorcontrib><creatorcontrib>Fonseca, Flávio G.</creatorcontrib><creatorcontrib>Durigon, Edison</creatorcontrib><creatorcontrib>Silva, João S.</creatorcontrib><creatorcontrib>de Souza, Renan P.</creatorcontrib><creatorcontrib>Goulart, Gisele A.C.</creatorcontrib><creatorcontrib>Santiago, Helton</creatorcontrib><creatorcontrib>Fernandes, Ana Paula S.</creatorcontrib><creatorcontrib>Teixeira, Santuza R.</creatorcontrib><creatorcontrib>Gazzinelli, Ricardo T.</creatorcontrib><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</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>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. 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immunology</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Spike Glycoprotein, Coronavirus - genetics</subject><subject>Spike Glycoprotein, Coronavirus - immunology</subject><subject>T-Lymphocytes - immunology</subject><subject>Toxicity</subject><subject>Transgenic mice</subject><subject>Vaccine</subject><subject>Vaccine Efficacy</subject><subject>Vaccines</subject><subject>Vaccines, Synthetic - administration & dosage</subject><subject>Vaccines, Synthetic - immunology</subject><subject>Viral diseases</subject><subject>viral load</subject><issn>0264-410X</issn><issn>1873-2518</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkU2P0zAQhi0EYsvCTwBZ4sJhU_wRJzEXVFV8SSuQaEHcLHcyblwldonTXfYH8T9x1cKBC5zm8sy8mvch5Clnc8549XI3v7EAPuBcMFHOuaikLu-RGW9qWQjFm_tkxkRVFiVn3y7Io5R2jDEluX5ILqSWVcOFnpGfq73_WKwRXtEFXVPAvi82NmFLR4Q4bHywYaLnKDp1dqI-0WQdXlE_DIcQtxg8XFEbWpq6eJto57cdRec8WLijPlD8scfRDxgm29MhttgnCp3tewzbHHTrp46uFp9XxTJ-LUQOG30OTTQ6CjEAjuExeeBsn_DJeV6SL2_frJfvi-tP7z4sF9cFSMWnQmygcTXn4ATTgEIxKbVVUpXa1shzE1rUtVZaMaYdSCsQsKp56wS4VqK8JC9Od_dj_H7ANJnBp2MnNmA8JCO5ko1Usqz-A-VSNkyJJqPP_0J38TCG_EimSiGU4LzMlDpRMMaURnRmn0uz453hzByVm505ezBH5eakPO89O18_bAZs_2z9dpyB1ycg9443HkeTwGPutfXZ8WTa6P8R8QuSwL6O</recordid><startdate>20241202</startdate><enddate>20241202</enddate><creator>Hojo-Souza, Natália S.</creator><creator>de Castro, Júlia T.</creator><creator>Rivelli, Graziella G.</creator><creator>Azevedo, Patrick O.</creator><creator>Oliveira, Emiliano R.</creator><creator>Faustino, Lídia P.</creator><creator>Salazar, Natália</creator><creator>Bagno, Flávia F.</creator><creator>Carvalho, Alex F.</creator><creator>Rattis, Bruna</creator><creator>Lourenço, Karine L.</creator><creator>Gomes, Isabela P.</creator><creator>Assis, Bruna R.D.</creator><creator>Piccin, Mariela</creator><creator>Fonseca, Flávio G.</creator><creator>Durigon, Edison</creator><creator>Silva, João S.</creator><creator>de Souza, Renan P.</creator><creator>Goulart, Gisele A.C.</creator><creator>Santiago, Helton</creator><creator>Fernandes, Ana Paula S.</creator><creator>Teixeira, Santuza R.</creator><creator>Gazzinelli, Ricardo T.</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7T2</scope><scope>7T5</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>7X8</scope><scope>7S9</scope><scope>L.6</scope></search><sort><creationdate>20241202</creationdate><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</title><author>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.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c351t-2bc8f711cf209ce250339a53549a7e141092779595009fc3a2ece671df2cfd3e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adjuvants</topic><topic>Adjuvants, Vaccine</topic><topic>Animals</topic><topic>Antibodies</topic><topic>Antibodies, Neutralizing - 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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.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>39368129</pmid><doi>10.1016/j.vaccine.2024.126394</doi><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0264-410X |
| ispartof | Vaccine, 2024-12, Vol.42 (26), p.126394, Article 126394 |
| issn | 0264-410X 1873-2518 1873-2518 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_3153835346 |
| source | Elsevier ScienceDirect Journals Complete - AutoHoldings; MEDLINE |
| subjects | Adjuvants Adjuvants, Vaccine Animals Antibodies Antibodies, Neutralizing - blood Antibodies, Neutralizing - immunology Antibodies, Viral - blood Antibodies, Viral - immunology Antigens Cell culture cell-mediated immunity clinical trials COVID-19 COVID-19 - immunology COVID-19 - prevention & control COVID-19 infection COVID-19 vaccines COVID-19 Vaccines - immunology Cricetinae Disease control Disease Models, Animal E coli Effectiveness Emergency response Enzymes Female genetically modified organisms Hamsters Humans Immune response Immune response (cell-mediated) Immune system Immunity Immunity (Disease) Immunization Immunization, Secondary Immunogenicity Immunogenicity, Vaccine Infections Laboratory animals lungs Lymphocytes Lymphocytes T Mice Mice, Transgenic Pandemics Proteins Rats recombinant proteins recombinant vaccines SARS-CoV-2 SARS-CoV-2 - immunology Severe acute respiratory syndrome coronavirus 2 Spike Glycoprotein, Coronavirus - genetics Spike Glycoprotein, Coronavirus - immunology T-Lymphocytes - immunology Toxicity Transgenic mice Vaccine Vaccine Efficacy Vaccines Vaccines, Synthetic - administration & dosage Vaccines, Synthetic - immunology Viral diseases viral load |
| 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 |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-16T17%3A19%3A56IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=SpiN-Tec:%20A%20T%20cell-based%20recombinant%20vaccine%20that%20is%20safe,%20immunogenic,%20and%20shows%20high%20efficacy%20in%20experimental%20models%20challenged%20with%20SARS-CoV-2%20variants%20of%20concern&rft.jtitle=Vaccine&rft.au=Hojo-Souza,%20Nat%C3%A1lia%20S.&rft.date=2024-12-02&rft.volume=42&rft.issue=26&rft.spage=126394&rft.pages=126394-&rft.artnum=126394&rft.issn=0264-410X&rft.eissn=1873-2518&rft_id=info:doi/10.1016/j.vaccine.2024.126394&rft_dat=%3Cproquest_cross%3E3113380528%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3142252114&rft_id=info:pmid/39368129&rft_els_id=S0264410X24010764&rfr_iscdi=true |