In March 2024 CEPI announced that an international consortium comprising experts in human challenge studies is beginning a project to develop advanced, virus-blocking coronavirus vaccines to prevent infection from SARS-CoV-2 and other coronaviruses. The project, worth $57 million, is led by Imperial College London and funded by the EU’s Horizon Europe Programme and CEPI. It involves “more than a dozen scientific teams and organisations” that will run trials to select viruses and identify the “best conditions under which to safely induce infection” in healthy volunteers.  

Once a virus is selected the researchers will attempt to infect healthy volunteers who have received an experimental vaccine. However, these vaccines will be inhaled or sprayed into the nose, designed to induce mucosal immunity. Scientists hope that this could “be the key” to stopping onward transmission of coronaviruses.  

Human challenge studies 

Human challenge studies are “unique in their ability to investigate and understand” disease onset and development in a “safe and highly controlled environment”. Imperial College London emphasises that the study is “carefully managed” in a “safe way”.  

“They allow researchers to tease out complicated interactions and point out potential targets for prevention, vaccines, or treatment that cannot be seen in patients who are infected naturally.”  

We heard more about how important they are from hVIVO’s Dr Andrew Catchpole last year, so do check out his interview if you’re interested in understanding how his team runs them.  

MusiCC 

The project is called Mucosal Immunity in human Coronavirus Challenge (MusiCC) and will last 5 years. Imperial College London’s researchers have acquired “years of experience” in using human challenge studies to “deepen scientific understand of a range of infectious diseases”. For example, in February 2021, Imperial ran the world’s first human challenge study for COVID-19. Imperial will collaborate with partners such as the University of Antwerp’s Vaccinopolis to establish human challenge models that can be applied across multiple trial sites. 

The trials will test potential mucosal candidates against betacoronaviruses, the sub-family that includes the SARS-CoV-2 viruses and MERS coronavirus among others. With harmonised standard operating procedures, the trials will be implemented at several sites in the UK, Europe, the US, and Singapore, involving small groups of young, healthy volunteers.  

The project is to ensure that any vaccines that are developed are made available “first and at an affordable price” to “the most vulnerable populations” in line with CEPI’s Equitable Access Policy. Data generated will be published with open access to benefit the international scientific community. 

Blocking transmission  

Dr Richard Hatchett, CEO of CEPI, states that “vaccines that can stop the transmission of a virus, rather than only reducing the severity of the disease it causes, are crucial to being able to end pandemic and epidemics swiftly”.  

“If we could find a way to induce virus-blocking mucosal immunity with the next generation of COVID-19 vaccines, for example, we could then dramatically reduce the circulation of the SARS-CoV-2 virus and hence limit its ability to generate dangerous new variants.”  

Professor Chris Chiu of Imperial College London, principal investigator for the project, reflected that “coronaviruses typically infect people through cells lining their nose, throat, and lungs”.  

“Mucosal immunity generated at these surfaces is highly specialised and very different to immune responses in the circulation. Since it directly acts in the place that viruses enter and exit the body, it could be the key to developing vaccines that can block viruses from being able to spread from one person to another.”  

Professor Chiu is excited to “bring together world class expertise in human challenge studies”.  

“With our partners, we will build on the fundamental groundwork we’ve already carried out at Imperial, and through our leading expertise and experience in human challenge studies for a range of pathogens, help to develop the next generation of transmission-blocking vaccines.”  

The European Commission’s Laurent Muschel, Head of HERA, and Marc Lemaître, Director-General for Research and Innovation, commented on the importance of research and innovation as “an essential part of the jigsaw” of “health emergency and pandemic preparedness”.  

“Supported through up to €35 million by the European Union’s Horizon Europe programme, MusiCC is an exciting and potential game-changing project, opening up the possibility to target and block viruses, stopping their transmission. Investing in research for health emergency preparedness and response remains a priority for the European Commission to protect the health of our citizens and public health beyond Europe.” 

Professor Hugh Brady, President of Imperial College London, is “delighted” that Professor Chris Chiu is leading the consortium. 

“Working with our global partners, we will be able to use human challenge studies to help develop future vaccines that will benefit humanity. This work is a fantastic example of Imperial’s ability to bring people and organisations together to create real-world impact.” 

We will hear more about human challenge models and their applications in respiratory virus research from Dr Catchpole at the Congress in Washington this April; do get your tickets to join us there and don’t forget to subscribe for more vaccine partnership insights.

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