Journal Article

DKFZ-2023-01685

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Phase I/II trial of a peptide-based COVID-19 T-cell activator in patients with B-cell deficiency.

Heitmann, J.DKFZ* ; Tandler, C. ; Marconato, M.DKFZ* ; Nelde, A. ; Habibzada, T. ; Rittig, S. M. ; Tegeler, C. M.DKFZ* ; Maringer, Y. ; Jaeger, S. U.DKFZ* ; Denk, M.DKFZ* ; Richter, M.DKFZ* ; Oezbek, M. T. ; Wiesmüller, K.-H. ; Bauer, J. ; Rieth, J. ; Wacker, M. ; Schroeder, S. M. ; Hoenisch Gravel, N. ; Scheid, J. ; Märklin, M.DKFZ* ; Henrich, A.DKFZ* ; Klimovich, B.DKFZ* ; Clar, K. L.DKFZ* ; Lutz, M. S.DKFZ* ; Holzmayer, S.DKFZ* ; Hörber, S. ; Peter, A. ; Meisner, C. ; Fischer, I. ; Löffler, M. W.DKFZ* ; Peuker, C. A. ; Habringer, S. ; Goetze, T. O. ; Jäger, E. ; Rammensee, H.-G.DKFZ* ; Salih, H.DKFZ* ; Walz, J.DKFZ*

2023
Nature Publishing Group UK [London]

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Please use a persistent id in citations: doi:10.1038/s41467-023-40758-0

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.

Keyword(s): Humans (MeSH) ; COVID-19 (MeSH) ; SARS-CoV-2 (MeSH) ; T-Lymphocytes (MeSH) ; Agammaglobulinemia (MeSH) ; Peptides: therapeutic use (MeSH) ; COVAC-1 COVID-19 vaccine ; Peptides

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Contributing Institute(s):

1. DKTK Koordinierungsstelle Tübingen (TU01)

Research Program(s):

1. 899 - ohne Topic (POF4-899) (POF4-899)

Appears in the scientific report 2023

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