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Heitmann, Jonas S; Bilich, Tatjana; Tandler, Claudia; Nelde, Annika; Maringer, Yacine; Marconato, Maddalena; Reusch, Julia; Jäger, Simon; Denk, Monika; Richter, Marion; Anton, Leonard; Weber, Lisa Marie; Roerden, Malte; Bauer, Jens; Rieth, Jonas; Wacker, Marcel; Hörber, Sebastian; Peter, Andreas; Meisner, Christoph; Fischer, Imma; Löffler, Markus W; Karbach, Julia; Jäger, Elke; Klein, Reinhild; Rammensee, Hans-Georg; Salih, Helmut R; Walz, Juliane S
Nature, 01/2022, Volume: 601, Issue: 7894Journal Article
T cell immunity is central for the control of viral infections. CoVac-1 is a peptide-based vaccine candidate, composed of SARS-CoV-2 T cell epitopes derived from various viral proteins , combined with the Toll-like receptor 1/2 agonist XS15 emulsified in Montanide ISA51 VG, aiming to induce profound SARS-CoV-2 T cell immunity to combat COVID-19. Here we conducted a phase I open-label trial, recruiting 36 participants aged 18-80 years, who received a single subcutaneous CoVac-1 vaccination. The primary end point was safety analysed until day 56. Immunogenicity in terms of CoVac-1-induced T cell response was analysed as the main secondary end point until day 28 and in the follow-up until month 3. No serious adverse events and no grade 4 adverse events were observed. Expected local granuloma formation was observed in all study participants, whereas systemic reactogenicity was absent or mild. SARS-CoV-2-specific T cell responses targeting multiple vaccine peptides were induced in all study participants, mediated by multifunctional T helper 1 CD4 and CD8 T cells. CoVac-1-induced IFNγ T cell responses persisted in the follow-up analyses and surpassed those detected after SARS-CoV-2 infection as well as after vaccination with approved vaccines. Furthermore, vaccine-induced T cell responses were unaffected by current SARS-CoV-2 variants of concern. Together, CoVac-1 showed a favourable safety profile and induced broad, potent and variant of concern-independent T cell responses, supporting the presently ongoing evaluation in a phase II trial for patients with B cell or antibody deficiency.
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