Phase I/II trial of a peptide-based COVID-19 T-cell activator in patients with B-cell deficiency.

Autor: 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
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Zdroj: Nature Communications; 8/18/2023, Vol. 14 Issue 1, p1-10, 10p
Abstrakt: 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. Here, Heitmann et al. report results from a Phase I/II trial evaluating CoVac-1, a peptide-based T-cell activator, in patients with B-cell deficiency, demonstrating potent induction of SARS-CoV-2-specific T-cell responses along with a favorable safety profile. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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