An international consortium of researchers specializing in human challenge studies is embarking on a $57 million project to develop advanced virus-blocking coronavirus vaccines.
Scientists will launch trials across several sites in the U.S., EU, U.K., and Singapore to test potential mucosal vaccine candidates in healthy volunteers.
Led by Imperial College London, the consortium is being co-funded by the European Union’s Horizon Europe Programme and the Coalition for Epidemic Preparedness Innovations (CEPI).
Human challenge studies are medical research studies during which volunteers are intentionally given an infection in a safe and controlled environment, with healthcare support.
The consortium of more than a dozen scientific teams and organizations will run trials to select particular viruses and identify the best conditions under which to safely induce infection in healthy volunteers.
Unlike traditional vaccines which are injected into muscle, volunteers will receive experimental vaccines inhaled into the lungs or sprayed in the nose which are designed to induce a type of protection known as mucosal immunity, which scientists believe could be the key to stopping onward transmission of coronaviruses.
“Vaccines that can stop transmission of a virus, rather than only reducing the severity of the disease it causes, are crucial to being able to end pandemics and epidemics swiftly,” said Dr. Richard Hatchett, CEPI’s CEO.
“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,” he said.
The five-year Mucosal Immunity in Human Coronavirus Challenge (MusiCC) project will be led by Imperial College London, which ran the world’s first human challenge study for COVID-19 in 2019, and currently leads the world’s first human challenge study for non-typhoidal salmonella.
“Coronaviruses typically infect people through cells lining their nose, throat and lungs. Mucosal immunity generated at these surfaces is highly specialized and very different to immune responses in the circulation,” said Chris Chiu, professor of infectious diseases at Imperial College London and principal investigator for MusiCC.
“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.”
The consortium partners, which include the University of Antwerp’s Vaccinopolis in Belgium, will work to establish human challenge models that can be used in multiple trial sites.
The trials will test potential mucosal vaccine candidates against betacoronaviruses, the sub-family of coronaviruses that includes the SARS-CoV-2 virus that causes COVID-19, several seasonal viruses that cause common colds, and the MERS coronavirus, which causes Middle East Respiratory Syndrome.
In the challenge trial, volunteers will first receive either a dose of an investigational vaccine designed to provide mucosal coronavirus immunity or placebo before being intentionally exposed to a calibrated dose of SARS-CoV-2 or other coronaviruses which cause a common cold.
A model using a seasonal coronavirus called OC43 is also being developed for similar use.
CEPI was launched in 2017, as a partnership between public, private, philanthropic, and civil organizations after the global response to the 2014-2016 West African Ebola epidemic fell tragically short. The latest project follows a call for proposals issued by CEPI.
Partners have issued an equity pledge to make available any vaccines that are developed to the most vulnerable populations first, and at affordable prices.
Data generated by MusiCC will be published with open access “for the benefit of the global scientific community.”
The European Commission’s Laurent Muschel, head of HERA (Health Emergency Preparedness and Response Authority), and Marc Lemaître, Director-General for Research and Innovation, said, “Supported through up to 35 million euros [$38 million] by the European Union’s Horizon Europe program, 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.”
