Development and manufacture of an improved replication-deficient simian adenoviral vector to prevent COVID-19

点击翻译按钮获取中文摘要

A leading candidate vaccine for COVID-19 is the chimpanzee adenoviral vector known as ChAdOx1 nCoV-19, which has been jointly developed and then exclusively licensed by the University of Oxford and Vaccitech to AstraZeneca. The vaccine is being evaluated in over 11,000 participants in the UK primarily as a single immunisation and in August will begin a 30,000-person Phase 3 study in the United States. There are concerns that this candidate vaccine may require a second dose, and may even be needed on a yearly basis, and that immune responses to the vector itself may limit the effectiveness of ChAdOx1 nCoV-19 over time. Vaccitech has developed a more immunogenic gorilla adenoviral vector with potential to have less vector cross-reactivity, induce stronger immune responses (both antibodies and T cells), and overcome some of the present concerns with ChAdOx1 nCoV-19. In this proposal all pre-clinical work will be completed to be ready to file a regulatory application to begin the initial Phase 1 clinical study. This preparation includes animal studies, clinical trial lot manufacture, formal toxicology studies, and any necessary regulatory interactions.