sudan ebolavirus - vaccine testing against sudan ebolavirus

There continues to be sporadic Ebolaviruses outbreaks in Africa with devastating societal and economic consequences. There are no licensed vaccines effective against _Sudan ebolavirus_ (SUDV) but there are ongoing outbreaks of filovirus in Africa. In Sept 2022, there was an outbreak of SUDV in Uganda with a case fatality rate of 47% (164 cases and 77 deaths). During this outbreak, SUDV spread rapidly into nine districts, including densely populated cities. Disease was controlled through contact tracing and quarantining cases; however, this approach is not always immediately effective. As SUDV causes the second highest number of filovirus outbreaks in Africa, there is an urgent and unmet need for vaccines against SUDV mediated disease. The costs of developing individual vaccines against each ebolavirus species was thought to be prohibitively expensive to reach the target population - in low- and middle-income countries (LMICs). However, this is not the case with the ChAdOx1 technology as evidenced during the COVID-19 pandemic which clearly demonstrated that the manufacture of ChAdOx1 vaccines can be scaled rapidly and robustly, at a price-point compatible with use in LMICs. We will generate a SUDV-specific ChAdOx1 vaccine ensuring optimised levels of antigen expression, we will initially test the vaccines _in vitro,_ progressing to _in vivo_ testing to ensure they are immunogenic, then working in collaboration with Rocky Mountain Laboratories we will test promising candidates in a well characterised SUDV challenge model. Once we have established the vaccine is protective against SUDV-mediated disease, a pre-GMP batch of vaccine will be generated with our on-site GMP experts Clinical Biomanufacturing Facility. A single-pathogen vaccine will be the quickest route to licensure. We will seek Phase 2 funding to test the monovalent SUDV vaccine in NHP challenge studies and generate a GMP batch of vaccine. We would propose a first in human clinical trial in the UK and subsequent Phase 1b testing in Uganda, or Tanzania or Kenya (collaborating partners in these countries have agreed to deliver a Phase 1 trial of our SUDV vaccine). This development pathway, for a monovalent SUDV vaccine, represents the fastest route to licensure and importantly, it is a development pathway familiar to regulators.