A Phase-1 clinical study for the application of the MVA-SARS-CoV-2-S vaccine candidate into the respiratory tract

Abstract

This grant co-funded a Phase-1 clinical study for the inhalative application of a MVA vector vaccine expressing a pre-fusion stabilized spike (S) protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This vector vaccine candidate (MVA-SARS-2-ST) has been created by our collaborator, late Prof. Gerd Sutter, LMU Munich, and has been produced under GMP standards by IDT Biologika. One of the intended uses is repeated intramuscular application in human to prevent corona virus disease 2019 (COVID-19). Based on several reflections and preclinical data obtained during the last years we also applied MVA SARS-2-ST by inhalation. Our data in mice have shown that this route of MVA application not only induces substantial amounts of tertiary lymphoid tissues, known as bronchus-associated lymphoid tissue (BALT), but also highly activated effector, as well as resident memory T and B cells. A GLP-compliant toxicology study that had been funded by DZIF confirmed that intramuscular priming followed by intranasal boosting is well tolerated in mice and does not cause adverse effects. We also finished preclinical studies regarding dose finding as well as optimizing the route of vaccine application. The latter studies were funded by the state of Lower Saxony that also provided substantial funds for a clinical phase I study addressing inhaled application of MVA-SARS-2-ST. During a Scientific Advice Meeting the Paul-Ehrlich-Institute, that is the regulatory body for vaccine approval in Germany, asked for additional bronchoscopies as well as further immunogenicity tests to investigate the vaccine’s potential to protect against several variants of concern (VoC) of SARS-CoV-2. This DZIF fund financed these additionally requested investigations. Datei-Upload durch TIB