nCoV: Rapid Clinical Development of ChAdOx1 nCoV-19

This COVID-19 Rapid Response award is jointly funded (50:50) between the Medical Research Council and the National Institute for Health Research. The figure displayed is the total award amount of the two funders combined, with each partner contributing equally towards the project. ChAdOx1 is a replication-deficient simian adenoviral vector that provides a platform technology for the production of vaccines against many infectious diseases. For Middle East Respiratory Syndrome (MERS) coronavirus, a single dose of the ChAdOx1-vectored MERS vaccine resulted in protection against MERS challenge in non-human primates and the induction of strong humoral and T cell responses in a Phase I clinical trial. The same vaccine design has now been followed to produce ChAdOx1 nCoV. Preclinical studies of the vaccine will be initiated by the end of February. This will include demonstration of vaccine immunogenicity (antibody and T cell) in mice, followed by vaccine immunogenicity and efficacy against nCoV-19 challenge in ferrets and non-human primates with collaborators at PHE Porton Down and NIH. A pre-GMP vaccine seed stock is in production at Oxford's GMP manufacturing facility, and will be provided to Advent, Italy, which will produce the first 1000 doses for clinical studies. In parallel with preclinical studies and vaccine manufacturing, Oxford will work with the MHRA on a rapid release testing package. This will employ deep sequencing of the Cell Harvest and Drug Substance to identify any potential replication competent adenovirus and adventitious agents rather than following the existing set of in vivo and in vitro assays, greatly reducing the time to cGMP certification. A phase I/II clinical trial will then be undertaken to demonstrate vaccine safety and immunogenicity in adults, older adults and children.