A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland
Abstract Background New vaccines with broader protection against SARS-CoV-2 are needed to reduce the risk of immune escape and provide broad and long-lasting cellular immunity. The objectives of the naNO-COVID trial were to evaluate the safety and immunogenicity of a CD8 + T cell, gold nanoparticle-...
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BMC
2025-04-01
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| Series: | BMC Infectious Diseases |
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| Online Access: | https://doi.org/10.1186/s12879-025-10844-3 |
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| author | Juliette Besson Régine Audran Maxime Karlen Alix Miauton Hélène Maby-El Hajjami Loane Warpelin-Decrausaz Loredana Sene Sylvain Schaufelberger Vincent Faivre Mohamed Faouzi Mary-Anne Hartley François Spertini Blaise Genton |
| author_facet | Juliette Besson Régine Audran Maxime Karlen Alix Miauton Hélène Maby-El Hajjami Loane Warpelin-Decrausaz Loredana Sene Sylvain Schaufelberger Vincent Faivre Mohamed Faouzi Mary-Anne Hartley François Spertini Blaise Genton |
| author_sort | Juliette Besson |
| collection | DOAJ |
| description | Abstract Background New vaccines with broader protection against SARS-CoV-2 are needed to reduce the risk of immune escape and provide broad and long-lasting cellular immunity. The objectives of the naNO-COVID trial were to evaluate the safety and immunogenicity of a CD8 + T cell, gold nanoparticle-based, peptide COVID-19 vaccine. Methods A randomized, double-blind, vehicle-controlled, phase 1 trial in healthy adults to receive PepGNP-Covid19 or Vehicle-GNP, followed over 180 days, using a dose-escalation strategy. Results Twenty participants received PepGNP-Covid19 (low dose [LD] or high dose [HD], n = 10 each) and six Vehicle-GNP (LD or HD, n = 3 each). Vaccinations were safe. No serious adverse events were reported. Most of the adverse events were mild, two adverse events of special interest related to the product (fever and fatigue). Reactogenicity was similar overall between vaccine, comparator, and doses. Virus-specific humoral responses in LD PepGNP-Covid19 and Vehicle-GNP groups coincided with SARS-CoV-2 infections. PepGNP-Covid19 vaccination induced the modulation of Covid19-specific CD137 + CD69 + CD8 + , and an increase at day 35 particularly in central and effector memory T cells in LD group, and in late effector memory cells in HD group. Conclusions The favourable safety profile and cellular responses observed support further development of PepGNP-Covid19. Trial registration ClinicalTrials.gov, NCT05113862, approved 09.11.2021. |
| format | Article |
| id | doaj-art-47ce7203f61b4ddcae29e23afa79ccda |
| institution | OA Journals |
| issn | 1471-2334 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj-art-47ce7203f61b4ddcae29e23afa79ccda2025-08-20T02:17:46ZengBMCBMC Infectious Diseases1471-23342025-04-0125111510.1186/s12879-025-10844-3A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in SwitzerlandJuliette Besson0Régine Audran1Maxime Karlen2Alix Miauton3Hélène Maby-El Hajjami4Loane Warpelin-Decrausaz5Loredana Sene6Sylvain Schaufelberger7Vincent Faivre8Mohamed Faouzi9Mary-Anne Hartley10François Spertini11Blaise Genton12Tropical, Travel and Vaccination Clinic, Center for Primary Care and Public Health (Unisanté), University of LausanneDivision of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois (CHUV), University of LausanneTropical, Travel and Vaccination Clinic, Center for Primary Care and Public Health (Unisanté), University of LausanneTropical, Travel and Vaccination Clinic, Center for Primary Care and Public Health (Unisanté), University of LausanneClinical Trial Unit, Centre Hospitalier Universitaire Vaudois (CHUV), University of LausanneClinical Trial Unit, Centre Hospitalier Universitaire Vaudois (CHUV), University of LausanneClinical Trial Unit, Centre Hospitalier Universitaire Vaudois (CHUV), University of LausanneInformation Systems and Digital Transformation, Center for Primary Care and Public Health (Unisanté), University of LausanneInformation Systems and Digital Transformation, Center for Primary Care and Public Health (Unisanté), University of LausanneDivision of Biostatistics, Center for Primary Care and Public Health (Unisanté), University of LausanneTropical, Travel and Vaccination Clinic, Center for Primary Care and Public Health (Unisanté), University of LausanneDivision of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois (CHUV), University of LausanneTropical, Travel and Vaccination Clinic, Center for Primary Care and Public Health (Unisanté), University of LausanneAbstract Background New vaccines with broader protection against SARS-CoV-2 are needed to reduce the risk of immune escape and provide broad and long-lasting cellular immunity. The objectives of the naNO-COVID trial were to evaluate the safety and immunogenicity of a CD8 + T cell, gold nanoparticle-based, peptide COVID-19 vaccine. Methods A randomized, double-blind, vehicle-controlled, phase 1 trial in healthy adults to receive PepGNP-Covid19 or Vehicle-GNP, followed over 180 days, using a dose-escalation strategy. Results Twenty participants received PepGNP-Covid19 (low dose [LD] or high dose [HD], n = 10 each) and six Vehicle-GNP (LD or HD, n = 3 each). Vaccinations were safe. No serious adverse events were reported. Most of the adverse events were mild, two adverse events of special interest related to the product (fever and fatigue). Reactogenicity was similar overall between vaccine, comparator, and doses. Virus-specific humoral responses in LD PepGNP-Covid19 and Vehicle-GNP groups coincided with SARS-CoV-2 infections. PepGNP-Covid19 vaccination induced the modulation of Covid19-specific CD137 + CD69 + CD8 + , and an increase at day 35 particularly in central and effector memory T cells in LD group, and in late effector memory cells in HD group. Conclusions The favourable safety profile and cellular responses observed support further development of PepGNP-Covid19. Trial registration ClinicalTrials.gov, NCT05113862, approved 09.11.2021.https://doi.org/10.1186/s12879-025-10844-3COVID-19SARS-CoV-2VaccineNanoparticleCellularImmunity |
| spellingShingle | Juliette Besson Régine Audran Maxime Karlen Alix Miauton Hélène Maby-El Hajjami Loane Warpelin-Decrausaz Loredana Sene Sylvain Schaufelberger Vincent Faivre Mohamed Faouzi Mary-Anne Hartley François Spertini Blaise Genton A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland BMC Infectious Diseases COVID-19 SARS-CoV-2 Vaccine Nanoparticle Cellular Immunity |
| title | A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland |
| title_full | A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland |
| title_fullStr | A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland |
| title_full_unstemmed | A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland |
| title_short | A gold nanoparticle/peptide vaccine designed to induce SARS-CoV-2-specific CD8 T cells: a double-blind, randomized, phase 1 study in Switzerland |
| title_sort | gold nanoparticle peptide vaccine designed to induce sars cov 2 specific cd8 t cells a double blind randomized phase 1 study in switzerland |
| topic | COVID-19 SARS-CoV-2 Vaccine Nanoparticle Cellular Immunity |
| url | https://doi.org/10.1186/s12879-025-10844-3 |
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