CEPI announced in May 2024 that it is supporting researchers from the University of Oxford on a project called ‘PREpare using Simulated Trial Optimisation (PRESTO)’. The scientists will use computer simulations to “generate important insights” on how vaccine clinical trials can be used to stop the spread of an emerging outbreak. CEPI is contributing $2.4 million to the Pandemic Sciences Institute; the diseases tested in this project are on CEPI’s priority list and WHO’s R&D Blueprint: Nipah, Chikungunya, Lassa, Rift Valley fever, Ebola and related viruses, Coronaviruses, and ‘Disease X’.
Getting a head start
Dr Richard Hatchett, CEO of CEPI, commented that as an outbreak occurs, we will not have time to “get all the information we need to tell us how best to conduct pivotal clinical trials”.
“Mathematical modelling can give us a head start by forecasting how a worrisome virus might spread and what we need to do to respond.”
The project’s optimal study designs will “allow health officials to make quick, informed decisions on the best steps” towards “more efficient vaccine testing and rapid evidence generation”. This will improve and accelerate the outbreak response.
Data generated in existing CEPI-funded research will be fed into a computer model with evidence from previous outbreaks to create hypothetical scenarios that investigate a selected virus. The findings from these scenarios will be used in analysis sheets that “rank the suitability of different clinical trial options”. CEPI offers the example of recommending a randomised controlled trial or a vaccination trial.
The project will span three years and begins with models of Nipah. Should an outbreak of Disease X occur, the team will direct their efforts to the emerging pathogen, making clinical trial data “rapidly available” to enable faster public health response efforts. The computer software will also be shared on an open-source platform and developed in a “modular manner” to allow external researchers to run tests and update the tool with new data.
100 Days Mission
This project aligns with CEPI’s 100 Days Mission by preparing clinical trial frameworks before an outbreak occurs. Professor Christophe Fraser, Professor of Infectious Disease Epidemiology at the Pandemic Sciences Institute, emphasised that “ensuring vaccines can be robustly tested at speed is critical” in efforts to “better respond” to future pandemic threats.
“With every day of delay potentially costing many lives, and with the recent experience from COVID-19, we now have an opportunity to develop improved vaccine clinical trial designs so we can hit the ground running in a disease outbreak.”
Professor Fraser states that the PRESTO project will bring together mathematical modellers, ethicists, regulators, vaccine manufacturers, and field teams to “study what works with different pathogens in different settings”.
“Our aim isn’t to find the theoretical abstract best solution, but to develop models that allow decision-makers to explore the impact of the inevitable trade-offs that they will have to make in different settings.”
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