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@ARTICLE{Heitmann:278641,
      author       = {J. Heitmann$^*$ and C. Tandler and M. Marconato$^*$ and A.
                      Nelde and T. Habibzada and S. M. Rittig and C. M.
                      Tegeler$^*$ and Y. Maringer and S. U. Jaeger$^*$ and M.
                      Denk$^*$ and M. Richter$^*$ and M. T. Oezbek and K.-H.
                      Wiesmüller and J. Bauer and J. Rieth and M. Wacker and S.
                      M. Schroeder and N. Hoenisch Gravel and J. Scheid and M.
                      Märklin$^*$ and A. Henrich$^*$ and B. Klimovich$^*$ and K.
                      L. Clar$^*$ and M. S. Lutz$^*$ and S. Holzmayer$^*$ and S.
                      Hörber and A. Peter and C. Meisner and I. Fischer and M. W.
                      Löffler$^*$ and C. A. Peuker and S. Habringer and T. O.
                      Goetze and E. Jäger and H.-G. Rammensee$^*$ and H.
                      Salih$^*$ and J. Walz$^*$},
      title        = {{P}hase {I}/{II} trial of a peptide-based {COVID}-19
                      {T}-cell activator in patients with {B}-cell deficiency.},
      journal      = {Nature Communications},
      volume       = {14},
      number       = {1},
      issn         = {2041-1723},
      address      = {[London]},
      publisher    = {Nature Publishing Group UK},
      reportid     = {DKFZ-2023-01685},
      pages        = {5032},
      year         = {2023},
      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.},
      keywords     = {Humans / COVID-19 / SARS-CoV-2 / T-Lymphocytes /
                      Agammaglobulinemia / Peptides: therapeutic use / COVAC-1
                      COVID-19 vaccine (NLM Chemicals) / Peptides (NLM Chemicals)},
      cin          = {TU01},
      ddc          = {500},
      cid          = {I:(DE-He78)TU01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:37596280},
      pmc          = {pmc:PMC10439231},
      doi          = {10.1038/s41467-023-40758-0},
      url          = {https://inrepo02.dkfz.de/record/278641},
}