دورية أكاديمية
Phase I/II trial of a peptide-based COVID-19 T-cell activator in patients with B-cell deficiency
| العنوان: | Phase I/II trial of a peptide-based COVID-19 T-cell activator in patients with B-cell deficiency |
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| المؤلفون: | Heitmann, Jonas S., Tandler, Claudia, Marconato, Maddalena, Nelde, Annika, Habibzada, Timorshah, Rittig, Susanne M., Tegeler, Christian M., Maringer, Yacine, Jaeger, Simon U., Denk, Monika, Richter, Marion, Oezbek, Melek T., Wiesmüller, Karl-Heinz, Bauer, Jens, Rieth, Jonas, Wacker, Marcel, Schroeder, Sarah M., Hoenisch Gravel, Naomi, Scheid, Jonas, Märklin, Melanie, Henrich, Annika, Klimovich, Boris, Clar, Kim L., Lutz, Martina, Holzmayer, Samuel, Hörber, Sebastian, Peter, Andreas, Meisner, Christoph, Fischer, Imma, Löffler, Markus W., Peuker, Caroline Anna, Habringer, Stefan, Goetze, Thorsten O., Jäger, Elke, Rammensee, Hans-Georg, Salih, Helmut R., Walz, Juliane S. |
| المساهمون: | Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg, Deutsche Forschungsgemeinschaft, Deutsches Krebsforschungszentrum |
| المصدر: | Nature Communications ; volume 14, issue 1 ; ISSN 2041-1723 |
| بيانات النشر: | Springer Science and Business Media LLC |
| سنة النشر: | 2023 |
| مصطلحات موضوعية: | General Physics and Astronomy, General Biochemistry, Genetics and Molecular Biology, General Chemistry, Multidisciplinary |
| الوصف: | T-cell immunity is central for control of COVID-19, particularly in patients incapable of mounting antibody responses. CoVac-1 is a peptide-based T-cell activator composed of SARS-CoV-2 epitopes with documented favorable safety profile and efficacy in terms of SARS-CoV-2-specific T-cell response. We here report a Phase I/II open-label trial (NCT04954469) in 54 patients with congenital or acquired B-cell deficiency receiving one subcutaneous CoVac-1 dose. Immunogenicity in terms of CoVac-1-induced T-cell responses and safety are the primary and secondary endpoints, respectively. No serious or grade 4 CoVac-1-related adverse events have been observed. Expected local granuloma formation has been observed in 94% of study subjects, whereas systemic reactogenicity has been mild or absent. SARS-CoV-2-specific T-cell responses have been induced in 86% of patients and are directed to multiple CoVac-1 peptides, not affected by any current Omicron variants and mediated by multifunctional T-helper 1 CD4 + T cells. CoVac-1-induced T-cell responses have exceeded those directed to the spike protein after mRNA-based vaccination of B-cell deficient patients and immunocompetent COVID-19 convalescents with and without seroconversion. Overall, our data show that CoVac-1 induces broad and potent T-cell responses in patients with B-cell/antibody deficiency with a favorable safety profile, which warrants advancement to pivotal Phase III safety and efficacy evaluation. ClinicalTrials.gov identifier NCT04954469. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1038/s41467-023-40758-0 |
| الإتاحة: | https://doi.org/10.1038/s41467-023-40758-0Test https://www.nature.com/articles/s41467-023-40758-0.pdfTest https://www.nature.com/articles/s41467-023-40758-0Test |
| حقوق: | https://creativecommons.org/licenses/by/4.0Test ; https://creativecommons.org/licenses/by/4.0Test |
| رقم الانضمام: | edsbas.F12E3B58 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1038/s41467-023-40758-0 |
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