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 1 , 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. A phase I open-label trial evaluating the immunogencity, reactogenicity and safety of a peptide-based SARS-CoV-2 vaccine candidate to induce SARS-CoV-2-specific T cell responses.
【저자키워드】 SARS-CoV-2, viral infection, Phase I trials, Peptide vaccines, 【초록키워드】 COVID-19, Vaccine, vaccination, immunogenicity, reactogenicity, Trial, Open-label, Immunity, Phase I, Vaccines, T cells, SARS-COV-2 infection, variant, SARS-CoV-2 variant, peptide, Local, Viral proteins, CD4, CD8, viral infections, Toll-like receptor, SARS-CoV-2 vaccine, B cell, Epitopes, T cell, Viral, T cell responses, Patient, peptides, Mild, Follow-up, receptor, T cell epitope, T cell response, safety profile, Analysis, T cell epitopes, open-label trial, deficiency, Serious Adverse Events, T helper, Serious Adverse Event, Viral protein, systemic reactogenicity, IFNγ, Study participants, participant, All study participants, end point, primary end point, CoVac-1, granuloma, immunogencity, peptide-based vaccine, event, composed, approved, conducted, analysed, peptide-based, induce, multifunctional, Montanide ISA51, surpassed, 【제목키워드】 COVID-19, Vaccine, Immunity,