TRANSVAC2 is the follow-up project to its successful predecessor project TRANSVAC, the European Network of Vaccine Research and Development funded under FP7. The TRANSVAC2 consortium comprises a comprehensive collection of leading European institutions that propose to further advance with the previous initiative towards the establishment of a fully operational and sustainable European vaccine R&D infrastructure. TRANSVAC2 will support innovation for both prophylactic and therapeutic vaccine development based on a disease-overarching and one-health approach, thereby optimising the knowledge and expertise gained during the development of both human and animal vaccines. This will be achieved by bridging the translational gap in biomedical research, and by supporting cooperation between public vaccine R&D institutions of excellence, related initiatives and networks in Europe, and industrial partners. TRANSVAC2 will complement and integrate with existing European research infrastructures in both the public and private sectors. TRANSVAC2 will function as leverage and innovation catalyst between all stakeholders involved in vaccine R&D in Europe and -by providing integrated and overarching vaccine R&D services- will contribute to the development of effective products to address European and global health challenges, to controlling the burden and spread of infectious diseases, and reinforce the economic assets represented by vaccine developers in Europe. The impact of TRANSVAC2 will be maximised by two external advisory bodies. An independent Scientific & Ethics Advisory Committee will provide recommendations surrounding scientific-technical and ethical issues, whereas the coordination of TRANSVAC2 with other related initiatives and the further promotion of the long-term stability of a European vaccine R&D infrastructure will be supported by a Board of Stakeholders comprising representatives of policy and decision makers, industry associations and European infrastructures.

Inno4Vac proposes an ambitious programme that will harness the latest advances in immunology, disease modelling, and modelling for tackling persistent scientific bottlenecks in vaccine development and for de-risking and accelerating this process. To reach this aim the project is divided into four interlinked subtopics. In Subtopic 1, artificial intelligence in combination with big data analysis and computational modelling will be used to build an open-access and cloud-based platform for in silico vaccine efficacy assessment and development. Subtopic 2 will develop new and improved controlled human infection models (CHIM) against influenza, RSV and C. difficile that will enable early vaccine efficacy evaluation. Subtopic 3 will contribute to the development of cell-based human in vitro 3D models that resemble the in vivo situation of an infection at the mucosa and more reliably predict immune protection. These models will be combined with the development of related functional immune assays for clinically relevant (surrogate) endpoints. Finally, Subtopic 4 will develop a modular one-stop computational platform for in silico modelling of vaccine bio-manufacturing and stability testing. In parallel to the scientific-technical work, the partners will develop strategies and roadmaps for positioning the newly developed models in the regulatory framework and integrating them into pharmaceutical vaccine development. The overall workplan is underpinned by horizontal activities on coordination/management and dissemination/communication, including data management and future sustainability. To achieve these ambitious objectives, Inno4Vacc has assembled a multidisciplinary consortium from academic and research institutions, industries, regulatory bodies, and vaccine R&D alliances. This unique partnership brings together clinical, immunological, microbiological, systems biology, mathematical models, and regulatory expertise and includes world-leaders in each respective field.

The TRANSVAC-DS project further builds on the outstanding success of EC-funded projects:TRANSVAC1 and TRANSVAC2 and proposes the establishment of a truly sustainable European vaccine infrastructure, which will build upon the lessons learned, activities and achievements of the TRANSVAC1/2 projects. Two infrastructure projects -TRANSVAC1 and TRANSVAC2- have been funded by the European Commission which -through the provision of state-of-the-art scientific-technical vaccine development services, technical training, and innovative vaccine research and development- have provided very significant support to European vaccine researchers and developers. Support has been, and is being provided to the development of human and veterinary prophylactic and therapeutic vaccines. The twenty-five partners in the TRANSVAC-DS consortium that will contribute to the outcome of the project represent ten EU Member States and Associated Countries and include leading organisations from the European vaccine R&D field. The main output of TRANSVAC-DS will be a conceptual design report that will describe in detail the maturity of the concept and be the basis for the establishment of a permanent and sustainable vaccine infrastructure of direct relevance to and benefit for Europe and further afield. As part of the design report, a five-year business plan will be delivered together with an implementation plan that will guide the further establishment of a sustainable European vaccine infrastructure.