| Autor: |
Jonas S. Heitmann, Claudia Tandler, Maddalena Marconato, Annika Nelde, Timorshah Habibzada, Susanne M. Rittig, Christian M. Tegeler, Yacine Maringer, Simon U. Jaeger, Monika Denk, Marion Richter, Melek T. Oezbek, Karl-Heinz Wiesmüller, Jens Bauer, Jonas Rieth, Marcel Wacker, Sarah M. Schroeder, Naomi Hoenisch Gravel, Jonas Scheid, Melanie Märklin, Annika Henrich, Boris Klimovich, Kim L. Clar, Martina Lutz, Samuel Holzmayer, Sebastian Hörber, Andreas Peter, Christoph Meisner, Imma Fischer, Markus W. Löffler, Caroline Anna Peuker, Stefan Habringer, Thorsten O. Goetze, Elke Jäger, Hans-Georg Rammensee, Helmut R. Salih, Juliane S. Walz |
| Jazyk: |
angličtina |
| Rok vydání: |
2023 |
| Předmět: |
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| Zdroj: |
Nature Communications, Vol 14, Iss 1, Pp 1-10 (2023) |
| Druh dokumentu: |
article |
| ISSN: |
2041-1723 |
| DOI: |
10.1038/s41467-023-40758-0 |
| Popis: |
Abstract 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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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