A single dose of a new mRNA vaccine against the Hantaan virus could survive on a shelf at room temperature, eliminating the need for freezer storage. The Hantaan virus, carried by field mice, causes haemorrhagic fever with renal syndrome and kills up to 15% of infected people. There are roughly 200,000 cases globally each year, yet no commercial vaccine exists. The problem is twofold: developing a vaccine for a neglected disease, and keeping mRNA vaccines stable without deep freezing—a major barrier to distribution in low-resource settings. This consortium combines three organisations. Emervax designs the mRNA antigen, Afrigen manufactures the lipid nanoparticle drug product, and EnsiliTech applies its ensilication technology—coating the vaccine in a silica shell—to make it thermostable. If successful, the project will produce a room-temperature-stable mRNA-LNP vaccine against Hantaan virus, validated through animal challenge studies. The broader impact is a platform. The same ensilication workflow could be templated onto other neglected diseases or emerging pathogens like Disease X. By removing the cold chain, the technology could make future mRNA vaccines accessible in regions without reliable refrigeration. The intellectual property will be licensed to governments or NGOs for manufacturing and distribution.
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EnsiliTech working with Afrigen and Emervax intend to develop a thermostable ensilicated messenger ribonucleic acid in lipid nanoparticle (mRNA-LNP) vaccine against the Hantaan virus (HTNV) that can be rapidly and equitably deployed globally. The Hantaan virus of the hantavirus family is predominantly present in Asia, although it occurs around the globe. It is transmitted through rodents, in this case the field mouse, as carriers to humans and causes haemorrhagic fever with renal syndrome (HFRS) that results in mortality up to 15% of infected individuals with yearly estimates of 200,000 cases globally. There is no vaccine commercially available. We believe that our combined effort and resources can contribute to the development of a safe, effective and modern vaccine against this virus. We strongly envision a world with equitable access to the latest vaccines that can prevent neglected infectious diseases. Emervax will provide their knowledge and experience in working on other Hantaviruses such as the Andes virus to the development of an mRNA cassette encoding the desired antigen. Afrigen will manufacture the drug substance (i.e. active pharmaceutical ingredient, API) and drug product which includes encapsulation within the LNP. EnsiliTech will investigate stabilisation of mRNA and mRNA-LNP using the ensilication technology, making it a room-temperature stable vaccine. This renders the cold chain logistics obsolete and increases accessibility and availability by extending shelf life and enhanced thermal stability. We believe this directly aligns with the scope and aims of the grant competition. We anticipated the results of this project to provide us with: * A novel antigenic mRNA construct efficacious against the HTNV demonstrated through _in vitro_ and _in vivo_ immunogenicity supported by challenge studies with subsequent first generation of mRNA-LNPs; * The establishment of mRNA-LNP ensilication and robust protocol thereof; * Thermostable vaccine formulation through ensilication; * Protective immunisation efficacy through intramuscular delivery _in vivo_ in rodents. The impact of the project would be the ability of this workflow to be templated on other neglected diseases and provide a platform for those emerging infectious pathogens such as Disease X. This project also addresses all key aspects towards the route to market for the final vaccine formulations. The created intellectual property (IP) will enable governmental bodies or non-governmental organisations to take a licence and support the manufacturing and distribution. Overall, our combined effort would intercalate and provide further opportunity for this consortium to become important contributors in the effort to improve global health.
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