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A COVID-19 peptide vaccine for the induction of SARS-CoV-2 T cell immunity

Jonas S. Heitmann, Tatjana Bilich, Claudia Tandler, Annika Nelde, Yacine Maringer, Maddalena Marconato, Julia Reusch, Simon Jäger, Monika Denk, Marion Richter, Leonard Anton, Lisa Marie Weber, Malte Roerden, Jens Bauer, Jonas Rieth, Marcel Wacker, Sebastian Hörber, Andreas Peter, Christoph Meisner, Imma Fischer, Markus W. Löffler, Julia Karbach, Elke Jäger, Reinhild Klein, Hans-Georg Rammensee, Helmut R. Salih and Juliane S. Walz ()
Additional contact information
Jonas S. Heitmann: University Hospital Tübingen
Tatjana Bilich: University Hospital Tübingen
Claudia Tandler: University Hospital Tübingen
Annika Nelde: University Hospital Tübingen
Yacine Maringer: University Hospital Tübingen
Maddalena Marconato: University Hospital Tübingen
Julia Reusch: University Hospital Tübingen
Monika Denk: University of Tübingen
Marion Richter: University of Tübingen
Leonard Anton: University Hospital Tübingen
Lisa Marie Weber: University Hospital Tübingen
Malte Roerden: University of Tübingen
Jens Bauer: University Hospital Tübingen
Jonas Rieth: University Hospital Tübingen
Marcel Wacker: University Hospital Tübingen
Sebastian Hörber: University Hospital Tübingen
Andreas Peter: University Hospital Tübingen
Christoph Meisner: University Hospital Tübingen
Imma Fischer: University Hospital Tübingen
Markus W. Löffler: University of Tübingen
Julia Karbach: Krankenhaus Nordwest
Elke Jäger: Krankenhaus Nordwest
Reinhild Klein: University Hospital Tübingen
Hans-Georg Rammensee: University of Tübingen
Helmut R. Salih: University Hospital Tübingen
Juliane S. Walz: University Hospital Tübingen

Nature, 2022, vol. 601, issue 7894, 617-622

Abstract: Abstract 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 proteins1,2, 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.

Date: 2022
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DOI: 10.1038/s41586-021-04232-5

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