Verona, Italy (23 October 2020) – seQure, an expert provider of Pharmacovigilance and Quality Assurance service, announced it is working with vaccine specialist ReiThera Srl (Rome, Italy) to support its Phase 1 study of a vaccine against the novel coronavirus (SARS-CoV-2). The study, which dosed the first healthy volunteer in August, is being conducted in Italy at the Lazzaro Spallanzani National Institute for Infectious Diseases (INMI) in Rome and at the Centro Ricerche Cliniche at G.B. Rossi University Hospital in Verona.
seQure will support ReiThera with Quality Assurance expertise, through the implementation and maintenance of a quality management system, to ensure Good Clinical Practice compliance of the study and maximise patient safety and trial validity.
ReiThera’s vaccine candidate GRAd-COV2 encodes the full-length spike protein of the SARS-CoV-2 coronavirus. The vaccine technology is based on a novel, proprietary replication-defective gorilla adenoviral (GRAd) vector, which induced a strong humoral and cellular immune response and demonstrated a good safety profile in preclinical studies. GRAd-COV2 is expected to induce strong immune responses based on low pre-existing immunity to the vector in humans.
Paolo Morelli, CEO of seQure, said: “We are proud to support ReiThera’s research by offering our expertise, and to be part of the global fight against COVID-19. It is truly amazing to be involved in this study and we hope that the combined experience of ReiThera and seQure will make a difference in finding a vaccine to combat COVID-19.”