PROTECTION FROM VIRUSES WITH EPIDEMIC AND PANDEMIC DISEASE OUTBREAK POTENTIAL THROUGH DEVELOPMENT AND CLINICAL TESTING OF A NOVEL CAPSID VIRUS LIKE PARTICLE (CVLP) VACCINE

ongoing

The enormous health and economic impacts of epidemics and pandemics has become one of the defining public policy and health issues in Europe and throughout the world. A new urgency is required to understand, rapidly respond to, and vaccinate against viruses with epidemic and pandemic potential. The major challenge for the modern vaccines is the induction of long-term protective immunity, as clearly demonstrated by fast waning of protection for current COVID-19 vaccines. VICI-DISEASE is an ambitious project which combines existing cutting-edge expertise in a tried and tested consortium, with new advances in this critical field. The consortium’s main objective is to develop a vaccine candidate portfolio and perform a clinical proof-of-concept study, to enable stocks of vaccine candidates ready for further development (Phase 2&3) in case of pandemic outbreaks. The primary candidate will be Nipah virus (NiV), a high-mortality viral disease with no vaccines or treatments. Our vaccine is based on NiV G protein displayed on capsid Virus Like Particle (cVLP), enabled by adapting template processes from our recent COVID-19 vaccine (currently in Phase 3), and expected to provide best-in-class longevity as shown for COVID-19. The VICI-DISEASE consortium’s objective is to develop and perform a clinical proof-of-concept study for • a highly effective (>90% protection), • long-term protective (>2 years), • NiV virus cVLP vaccine, • by adapting template processes established for our COVID-19 vaccine (currently in Phase 3), • within 48 months in a Phase 1/2a clinical study, • to help protect medical workers and the public from future NiV and Hendra virus outbreaks, • and establish a pipeline of novel filovirus vaccines through pre-clinical proof-of-concept studies. We address the call topic by improving pandemic preparedness and response through development of a NiV vaccine to Ph1/2 and two filovirus vaccines to pre-clinical proof-of-concept.