Prevention of SARS-CoV-2 infection through development and clinical testing of a novel Virus Like Particle (VLP) vaccine

Our aim is to perform pre-clinical and clinical evaluation of a potential Wuhan Coronavirus vaccine candidate. The vaccine will be based on Virus-Like Particle (VLP) display of the SARS-CoV-2 Spike protein antigen. AdaptVac's VLP display technology has been shown to significantly improve vaccine immunogenicity, longevity and efficacy, for a wide range of viral and parasite diseases in pre-clinical studies (including flu and malaria). A unique feature of the technology is its two component approach. The VLP is generic to all vaccines, and produced at >1g/L yields using E.coli. The disease antigen is produced in any expression system, allowing the most challenging antigens to be successfully produced. The VLP and antigen is then simply mixed, and a spontaneous, irreversible, conjugation occurs under physiological conditions. This results in site-specific, directional , and high density display of the antigen on the VLP surface. The antigen will be produced using ExpreS2ion's Drosophila S2 insect cells (as trimetric full-length spike proteins). Furthermore, E.coli and baculovirus will be tested for Spike protein variants. The vaccine candidates will be tested pre-clinically using in vitro viral neutralisation assays and possibly animal challenge models as they become available at LUMC. ExpreS2ion will develop the production processes and transfer these for GMP manufacture of the VLP and vaccine antigen, outsourced, to IntraVacc (NL). Finally, a phase I/IIa study will be performed at EKUT, University of Tübingen, Germany. A surrogate marker of protection will be established by showing protection in animal models using passive transfer of patient sera, or by in vitro SARS-CoV-2 viral neutralisation. This project is focused on delivering a scalable vaccine, ready for testing in the field, which has been shown to be safe in humans and effective in in vitro or animal models.