African swine fever (ASF) has recently transformed from an exotic disease to a panzootic threat to domestic and wild suids world-wide. Europe is currently facing different scenarios with front and point introductions, affected wild boar and domestic pig populations, epidemic and endemic situations. While our traditional prevention and control strategies work well with industrial pig farms, we quickly reach our limits when we have to control the disease in the abundant wild boar population or in regions with a majority of backyard farms. To turn the tide and to safeguard animal health, vaccines, especially oral vaccines for wild boar, could be the missing tool. There has been considerable progress in vaccine development and while we should continue to look for alternative approaches, we must now also dare to test the promising candidates beyond simple proof-of-concept studies. Only in this way can we generate the data base for benefit-risk analysis of whether and how current generation vaccines could be employed. Along these lines, this project sets out to test the vaccine candidate "ASFV-G-ΔI177L" in safety and efficacy tests after oral and intramuscular application as prescribed by international guidelines. This vaccine candidate has shown safety and very good protection under laboratory conditions and has been applied in the field in Vietnam. As a backup option, other promising candidates, “ASFV-G-ΔMGF” and “ASFV-G-Δ9GL/UK, will be tested in initial comparative trials. Accompanying the prescribed tests, our interdisciplinary consortium will characterize the protective immune responses, target the optimization of oral immunization and model tailored vaccination strategies. The data body generated in this project is crucial for benefit-risk-assessments at the level of all authorities entrusted with licensure and deployment of ASF vaccines and for this reason, relevant stakeholders will be involved from the start to guarantee full exploitation of our data.

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.

Influenza is a major public health problem. In a conservative estimate, influenza infects annually 60 of the 500 million inhabitants of the EU. Vaccines are the cornerstone for preventing influenza and its consequences. Current influenza vaccines have a moderate variable effect, given the mismatch between vaccine and circulating strains, waning immunity and interference from previous vaccination, among others. The single most important challenge in achieving VE studies for the various influenza vaccines put every year on the European market is the ability of the different stakeholders to work in collaboration. To enable a sustainable network of influenza vaccine VE studies, the Development of Robust and Innovative Vaccines Effectiveness (DRIVE) main goal will be the development of a governance model between public and private entities. This model will ensure scientific independence in the studies and full transparency, allowing different stakeholders to fulfill their needs taking into account their respective obligations and statutes. A second challenge will be to reach the capacity to perform vaccine brand- specific effectiveness studies, which is agile enough to deliver the needed outputs in timely manner, and robust enough to provide results by different age and risk groups and flexible enough to utilize novel tools while at the same time aims to be sustainable. Combining these outputs, DRIVE will establish a sustainable platform for joint influenza vaccine effectiveness evaluation which will have a positive impact on European citizens public health.

The European Rare Diseases Research Alliance (ERDERA) aims to improve the health and well-being of the 30 million people living with a rare disease in Europe, by making Europe a world leader in Rare Disease (RD) research and innovation, to support concrete health benefits to rare disease patients, through better prevention, diagnosis and treatment. This Partnership will deliver a RD ecosystem that builds on the successes of previous programmes by supporting robust patient need-led research, developing new diagnostic methods and pathways, spearheading the digital transformational change connecting the dots between care, patient data and research, while ensuring strong alignment of strategies in RD research across countries and regions. Structuring goal-oriented public-private collaborations targeted at interventions all along the R&D value chain will ensure that the journey from knowledge to patient impact is expedited, thereby optimising EU innovation potential in RD. To support its ambition and missions ERDERA has been designed as a comprehensive and integrated ecosystem of which structure can be compared to an institute encompassing three main parts: (i) funding, (ii) internal (in house) Clinical Research Network that implements research activities targeting clinical trial readiness of RDs and accelerating diagnosis and translation of research discovery into improved patient care, and (iii) related supporting services (Data, Expertise, Education and Training) as well as an acceleration hub that serve external and internal RD community, all supported by all-embracing coordination and strategy and foundational (inter)national alignment.

Lessons learned from, and intervention efforts against SARS coronavirus (CoV), MERS-CoV and other emerging viruses provide invaluable information to accelerate the coordinated response against 2019 novel (2019 -n)CoV and the rapid development and manufacture of new diagnostic, prophylactic and therapeutic intervention strategies. A -promising approach to both patient management of emerging viral infections and to better preparedness and response to emerging epidemics is the use of monoclonal antibodies. MANCO aims at contributing to the rapid international response against 2019-nCoV, through preclinical and clinical evaluation of monoclonal antibodies against 2019-nCoV. MANCO will build on and leverage outstanding results from ongoing IMI-funded project #115760 ZAPI, including recently-discovered broadly cross-reactive H2L2 monoclonal antibodies against betacoronaviruses and an established pipeline for rapid identification of specific H2L2 monoclonal antibodies against 2019-nCoV; antibodies that will be selected to proceed to GMP manufacturing in high-yield CHO cell-lines. This project furthermore builds on ZAPI consortium’s experience and expertise for the development and establishment of relevant animal models, to ensure preclinical efficacy and safety, including absence of antibody-dependent enhancement, an issue seen to occur in some immunization studies against feline and SARS CoVs. Based on the generated preclinical data, MANCO will advance one lead (prophylactic and/or therapeutic) monoclonal antibody into a Phase I clinical trial that can be completed within two years of the start of the project, by leveraging clinical expertise, infrastructure and network currently in place for ongoing CEPI-funded projects on candidate vaccines against MERS-CoV (#INID1801) and Rift Valley Fever virus (#INLA1901), and H2020-funded projects on improved vaccines targeting the elderly (ISOLDA #848166) and on universal influenza vaccines, including in LMICs (ENDFLU #874650).