International projects
Live attenuated replication-defective influenza vaccine
Organisations (1)
Abstract
We propose to develop an intranasal vaccine against pandemic influenza, based on reverse genetics. This technology will permit to rapidly generate replication-defective strains from new emerging influenza viruses that are safe and effective. We will generate reassortant vaccine viruses containing the surface glycoproteins from emerging wild-type influenza strains and the internal proteins of a master strain lacking the NS1 gene. The efficacy and safety of the resulting vaccine strains will be evaluated in chickens and ferrets. In addition we will scale up our production technology based on Vero cells. To establishing a fast and efficient downstream process we will further develop and scale up our purification method on monolithic columns. Subsequently, after toxicological evaluation of the cGMP produced candidate vaccines, clinical studies will be performed in healthy volunteers.The complementary constellation, the quality of the partners, efficient project management and availability of the combined resources will enable to successfully reach the goals of this project. It will allow the SMEs to significantly shorten the time necessary for the preclinical development phase and will bring the proposed chimeric vaccine viruses a major step closer to a marketable stage. Therefore, the project will contribute to the integration of partners in European research networks and, by its highly innovative features strengthen the European research. Through the involvement of partners from the Czech republic and from Slovenia this project contributes to the integration of new member states. Due to the enormous market potential, significant earnings can be expected. The patents, virus strains and technologies generated through these project will allow the SMEs to negotiate significant upfront, licensing and royalties payments from pharmaceutical companies.
