OSE Immunotherapeutics SA announced a voluntary and temporary pause of enrollment and dosing in its ongoing Phase 1 clinical trial for CoVepiT, the company’s investigational prophylactic COVID-19 vaccine candidate. OSE Immunotherapeutics notified the Belgian Health Authorities that the Company is voluntarily pausing its Phase 1 clinical study of CoVepiT in healthy volunteers. This pause was decided after receiving a preliminary update by the trial’s principal investigator at the Center for Vaccinology, Ghent University, regarding a limited number of Grade 1 and one Grade 2 adverse events, in particular, persistent nodules around injection points (subcutaneous, with no pain, no inflammation, no fever, no impact on everyday life and without any systemic symptoms). Out of an abundance of caution, and in agreement with the independent Safety Monitoring Committee (SMC), the Company has decided to voluntarily pause dosing in its ongoing clinical study and assess the evolution of these nodules before determining the best way forward for this product and its target population. The Company will carefully review all available data to determine the future clinical development strategy of CoVepiT. About CoVepiT: CoVepiT is a next-generation multi-target, multi-variant vaccine against SARS-CoV-2 designed to generate robust CD8 T cell responses and supported by Bpifrance1,2 and in clinical Phase 1 (EudraCT 2021-000572-11 and clinicaltrials.gov identifier: NCT04885361). The study seeks to assess CD8+ T Cell responses to spike and additional non-spike antigens from SARS-CoV-2 with aim of augmenting clinical protection against spike variants of concern. The vaccine candidate was designed using optimized epitopes selected after screening more than 67,000 global SARS-CoV-2 genomes, as well as those of previous human-infective CoVs, SARS and MERS, to identify vaccine targets with the lowest chance of natural mutation. Targeting 11 virus proteins including Spike, M, N and several nonstructural proteins, this second-generation vaccine covers all initial and novel SARS-CoV-2 variants identified globally to date. In preclinical testing, CoVepiT demonstrated the ability to activate T cell defenses through CD8 T-cell multi-epitope responses for long-term T memory cell immunity.