Phase I Trial of Multi-Peptide COVID-19 Vaccine for Induction of SARS-CoV-2 T-Cell Immunity

 

Juliane Walz, Jonas Heitmann, Tatjana Bilich, Claudia Tandler, Annika Nelde, Yacine Maringer, Maddalena Marconato, Julia Reusch, Simon Jäger, Monika Denk, Marion Richter, Leonard Anton, Lisa Weber, Malte Roerden, Jens Bauer, Jonas Rieth, Marcel Wacker, Sebastian Hörber, Andreas Peter, Christoph Meisner, Imma Fischer, Markus Löffler, Reinhild Klein, Hans-Georg Rammensee, Helmut Salih

DOI:

10.21203/rs.3.rs-820910/v1

PDF: https://www.researchsquare.com/article/rs-820910/v1.pdf?c=1629489587000

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 MontanideTM ISA51 VG, aiming to induce superior SARS-CoV-2 T-cell immunity to combat COVID-19. We conducted a Phase I open-label trial, including 36 participants aged 18 to 80 years, who received one single subcutaneous CoVAC-1 vaccination. The primary endpoint was safety analyzed until day 56. Immunogenicity in terms of CoVac-1-induced T-cell response was analyzed as main secondary endpoint until day 28. No serious adverse events and no grade 4 adverse events were observed. Expected local granuloma formation was observed in all study subjects, while 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 interferon-γ T-cell responses by far surpassed those detected in COVID-19 convalescents and were unaffected by current SARS-CoV-2 variants of concern (VOC). Together, CoVac-1 showed a favorable safety profile and induced broad, potent, and VOC-independent T-cell responses, supporting the presently ongoing evaluation in a Phase II trial for patients with B-cell/antibody deficiency.

Funded by the Ministry of Science, Research and the Arts Baden-Württemberg, Germany; ClinicalTrials.gov number, NCT04546841.

Yes there is potential Competing Interest. T.B., A.N.,H.-G.R., and J.S.W. are listed as inventors on a patent related to the SARS-CoV-2 T cell epitopes included in CoVac-1. H.-G.R. is listed as inventor on a patent related to the adjuvant XS15 included in CoVac-1.

https://www.researchsquare.com/article/rs-820910/v1