Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-08-2014 | Award Amount: 25.06M | Year: 2015
The TBVAC2020 proposal builds on the highly successful and long-standing collaborations in subsequent EC-FP5-, FP6- and FP7-funded TB vaccine and biomarker projects, but also brings in a large number of new key partners from excellent laboratories from Europe, USA, Asia, Africa and Australia, many of which are global leaders in the TB field. This was initiated by launching an open call for Expressions of Interest (EoI) prior to this application and to which interested parties could respond. In total, 115 EoIs were received and ranked by the TBVI Steering Committee using proposed H2020 evaluation criteria. This led to the prioritisation of 52 R&D approaches included in this proposal. TBVAC2020 aims to innovate and diversify the current TB vaccine and biomarker pipeline while at the same time applying portfolio management using gating and priority setting criteria to select as early as possible the most promising TB vaccine candidates, and accelerate their development. TBVAC2020 proposes to achieve this by combining creative bottom-up approaches for vaccine discovery (WP1), new preclinical models addressing clinical challenges (WP2) and identification and characterisation of correlates of protection (WP5) with a directive top-down portfolio management approach aiming to select the most promising TB vaccine candidates by their comparative evaluation using objective gating and priority setting criteria (WP6) and by supporting direct, head-to head or comparative preclinical and early clinical evaluation (WP3, WP4). This approach will both innovate and diversify the existing TB vaccine and biomarker pipeline as well as accelerate development of most promising TB vaccine candidates through early development stages. The proposed approach and involvement of many internationally leading groups in the TB vaccine and biomarker area in TBVAC2020 fully aligns with the Global TB Vaccine Partnerships (GTBVP).
Agency: European Commission | Branch: H2020 | Program: SGA-RIA | Phase: FETFLAGSHIP | Award Amount: 89.00M | Year: 2016
Understanding the human brain is one of the greatest scientific challenges of our time. Such an understanding can provide profound insights into our humanity, leading to fundamentally new computing technologies, and transforming the diagnosis and treatment of brain disorders. Modern ICT brings this prospect within reach. The HBP Flagship Initiative (HBP) thus proposes a unique strategy that uses ICT to integrate neuroscience data from around the world, to develop a unified multi-level understanding of the brain and diseases, and ultimately to emulate its computational capabilities. The goal is to catalyze a global collaborative effort. During the HBPs first Specific Grant Agreement (SGA1), the HBP Core Project will outline the basis for building and operating a tightly integrated Research Infrastructure, providing HBP researchers and the scientific Community with unique resources and capabilities. Partnering Projects will enable independent research groups to expand the capabilities of the HBP Platforms, in order to use them to address otherwise intractable problems in neuroscience, computing and medicine in the future. In addition, collaborations with other national, European and international initiatives will create synergies, maximizing returns on research investment. SGA1 covers the detailed steps that will be taken to move the HBP closer to achieving its ambitious Flagship Objectives.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-23-2014 | Award Amount: 6.96M | Year: 2015
Childrens health affects the future of Europe children are citizens, future workers, parents and carers. Children are dependent on society to provide effective health services (UN Convention on the Rights of the Child). Models of child primary health care vary widely across Europe based on two broad alternatives (primary care paediatricians or generic family doctors), and a variety of models of school health and adolescent direct access services. There is little research to show which model(s) are best, implying that some are inefficient or ineffective, with sub-optimal outcomes. MOCHA will draw on networks, earlier child health projects and local agents to model and evaluate child primary care in all 30 EU/EEA countries. Scientific partners from 11 European countries, plus partners from Australia and USA, encompassing medicine, nursing, economics, informatics, sociology and policy management, will: Categorise the models, and school health and adolescent services Develop innovative measures of quality, outcome, cost, and workforce of each, and apply them using policy documents, routine statistics, and available electronic data sets Assess effects on equality, and on continuity of care with secondary care. Systematically obtain stakeholder views. Indicate optimal future patterns of electronic records and big data to optimise operation of the model(s). The results will demonstrate the optimal model(s) of childrens primary care with a prevention and wellness focus, with an analysis of factors (including cultural) which might facilitate adoption, and indications for policy makers of both the health and economic gains possible. The project will have a strong dissemination programme throughout to ensure dialogue with public, professionals, policy makers, and politicians. The project will take 42 months (36 of scientific work plus start up and close), and deliver major awareness and potential benefit for European childrens health and healthy society.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-13-2014 | Award Amount: 7.57M | Year: 2015
Immune responses are initiated by antigen presentation mediated by dendritic cells (DC). There is a minority subset of DC highly specialised in starting up cytotoxic T lymphocytes able to kill tumor cells. PROCROP aims to develop in three pilot clinical trials a suitable individualized cancer vaccine technology for castration resistant prostate cancer and metastatic cancer of the ovary that would complement currently available therapies to increase efficacy. The project applies recent compelling knowledge on the identity of the main antigen-presenting DC subsets for vaccine elicitation of cytotoxic T lymphocytes endowed with the ability to seek and destroy tumour cells (such immune mechanism is termed crosspriming). This unique opportunity for superior DCs for immunotherapy comes from the fact that Miltenyi, a successful European biotech company, has the necessary proprietary reagents (anti-BDCA-3 monoclonal antibody and immunomagnetic selection technology), as well as the expertise to clinically develop a strategy of DC isolation and short-term cell culture for immunotherapy. From the point of view of the tumor antigens, processed autologous tumor material will be mixed with defined common tumor antigens in the form of recombinant proteins. This novel combination will permit stronger and broader antitumor immune responses and more accurate monitoring of the ensuing immunity against the tumors. These features should make the novel DC vaccine more efficacious than the currently US-approved DC vaccine PROVENGE and other DCs preparations undergoing trials, such as those derived from monocytes. Three of the leading groups in immunotherapy of cancer in Europe would join forces to develop this individualized cell therapy technology in clinical trials for two highly prevalent and unsatisfactorily managed malignant conditions. Industrial partnership provides the unique advantage of producing a rigorously standardized product for eventual multicentre trials.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-09-2015 | Award Amount: 28.14M | Year: 2016
Many HIV vaccine concepts and several efficacy trials have been conducted in the prophylactic and therapeutic fields with limited success. There is an urgent need to develop better vaccines and tools predictive of immunogenicity and of correlates of protection at early stage of vaccine development to mitigate the risks of failure. To address these complex and challenging scientific issues, the European HIV Vaccine Alliance (EHVA) program will develop a Multidisciplinary Vaccine Platform (MVP) in the fields of prophylactic and therapeutic HIV vaccines. The Specific Objectives of the MVP are to build up: 1.Discovery Platform with the goal of generating novel vaccine candidates inducing potent neutralizing and non-neutralizing antibody responses and T-cell responses, 2. Immune Profiling Platform with the goal of ranking novel and existing (benchmark) vaccine candidates on the basis of the immune profile, 3. Data Management/Integration/Down-Selection Platform, with the goal of providing statistical tools for the analysis and interpretation of complex data and algorithms for the efficient selection of vaccines, and 4. Clinical Trials Platform with the goal of accelerating the clinical development of novel vaccines and the early prediction of vaccine failure. EHVA project has developed a global and innovative strategy which includes: a) the multidisciplinary expertise involving immunologists, virologists, structural biology experts, statisticians and computational scientists and clinicians; b) the most innovative technologies to profile immune response and virus reservoir; c) the access to large cohort studies bringing together top European clinical scientists/centres in the fields of prophylactic and therapeutic vaccines, d) the access to a panel of experimental HIV vaccines under clinical development that will be used as benchmark, and e) the liaison to a number of African leading scientists/programs which will foster the testing of future EHVA vaccines through EDCTP
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-14-2015 | Award Amount: 7.47M | Year: 2016
Severe combined immunodeficiency (SCID) is a devastating rare disorder of immune system development. Affected infants are born without functional immune systems and die within the first year of life unless effective treatment is given. Treatment options are limited to allogeneic haematopoietic stem cell transplantation and autologous stem cell gene therapy. Over the last 15 years, gene therapy for two forms of SCID (SCID-X1 and ADA SCID) has shown significant safety and efficacy in correcting the immunodeficiency and allowing children to live normal lives. Proof of concept of gene therapy for 3 other SCID forms has also been shown by members of the proposed SCIDNET consortium and is ready for translation into clinical trials. We are therefore in a position whereby, over the next 4 years, we can offer gene therapy as a curative option for over 80% of all forms of SCID in Europe. Importantly for 1 of these conditions (ADA SCID) we will undertake clinical trials that will lead to marketing authorisation of the gene therapy product as a licensed medicine. In addition, we will investigate the future technologies that will improve the safety and efficacy of gene therapy for SCID. Our proposal addresses an unmet clinical need in SCID, which is classified as a rare disease according to EU criteria (EC regulation No. 141/2000). The proposal also addresses the need to develop an innovative treatment such as gene therapy from early clinical trials though to a licensed medicinal product through involvement with regulatory agencies and is in keeping with the ambitions of the IRDiRC. The lead ADA SCID programme has Orphan Drug Designation and clinical trial design is assisted by engagement with the European medicines Agency. The ADA SCID trial will act as a paradigm for the development of the technologies and processes that will allow gene therapy for not only SCID, but also other bone marrow disorders, to become authorised genetic medicines in the future.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: PHC-01-2014 | Award Amount: 7.26M | Year: 2015
The dramatic differentials in healthy ageing, quality of life and life expectancy between individuals of different socioeconomic groups, is a major societal challenge facing Europe. The overarching aim of the LIFEPATH project is to understand the determinants of diverging ageing pathways among individuals belonging to different socio-economic groups. This will be achieved via an original study design that integrates social science approaches with biology (including molecular epidemiology), using existing population cohorts and omics measurements (particularly epigenomics). The specific objectives of the project are: (a) To show that healthy ageing is an achievable goal for society, as it is already experienced by individuals of high socio-economic status (SES); (b) To improve the understanding of the mechanisms through which healthy ageing pathways diverge by SES, by investigating lifecourse biological pathways using omic technologies; (c) To examine the consequences of the current economic recession on health and the biology of ageing (and the consequent increase in social inequalities); (d) To provide updated, relevant and innovative evidence for healthy ageing policies (particularly health in all policies) that address social disparities in ageing and the social determinants of health, using both observational studies as well as an experimental approach based on the existing conditional cash transfer experiment in New York. To achieve these objectives we will use data from three categories of studies: 1. Europe-wide or national surveys combined with population registry data; 2. Cohorts with intense phenotyping and repeat biological samples (total population >33,000); 3. Large cohorts with biological samples (total population >202,000). The cohorts will provide information on healthy ageing at different stages of life, based on the concepts of life-course epidemiology (build-up and decline) and multimorbidity.
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: SC1-PM-09-2016 | Award Amount: 6.00M | Year: 2017
Ischemic stroke (IS), caused by occlusion of arteries that supply blood to the brain, remains a leading cause of mortality and morbidity in the world. Disruption of blood and oxygen supply to the brain leads to neuronal death in the ischemic core within minutes. The hypoperfused tissue surrounding the ischemic core, the penumbra, is at high risk for infarction over time but still salvageable. Neuroprotective bridging, sustaining the penumbra until reperfusion, may widen the therapeutic window, make recanalization treatments accessible to more patients and improve overall IS outcomes. As ischemic cell death is primarily mediated by hypoxia, increasing oxygen supply to the penumbra seems THE logical approach. In animal models of IS, normobaric hyperoxygenation (NBHO) significantly increased penumbral oxygen pressure and attenuated brain injury when initiated early after onset of ischaemia and vessel occlusion was transient (35 to 50% infarct volume reduction). The PROOF project now seeks to demonstrate that NBHO (high-flow 100% oxygen at >45 L/min via a non-rebreather mask, or FiO2=1.0 for intubation/ventilation) reduces infarct growth from baseline to 24 hours compared to standard treatment if administered 3 hours after onset of anterior circulation IS, in patients with proximal vessel occlusion and salvageable tissue at risk. The study is multi-center, adaptive phase-IIb, randomized, open-label with blinded-endpoint (PROBE design). The primary efficacy criterion will be infarct growth from baseline to 24 hours. Secondary endpoints will be NIHSS 24h, categorical shift in the pre-stroke modified Rankin Score, QoL and cognition at day 90. Potential surrogate biomarkers, health economics and societal impacts will be assessed. If NBHO proves its neuroprotective potential in this selected population, phase-III trials in all IS patients may be undertaken. Considering its low costs and ease of use, NBHO may impact stroke care worldwide.
Agency: European Commission | Branch: H2020 | Program: MSCA-ITN-ETN | Phase: MSCA-ITN-2015-ETN | Award Amount: 3.90M | Year: 2016
ESA-ITN will break through the state of the art in sepsis diagnostics and will train 15 early-stage researchers (ESRs) to determine the clinical potency of a variety of new complementary sepsis biomarkers. These cover the full range of the antiinflammatory response in sepsis, at genetic, molecular and cellular level. Rapid and practical biomarker diagnostics for sepsis will be developed by building on some of the worlds most innovative diagnostic platforms. In addition, a whole new clinical research model that incorporates use of biomarker diagnostics will be designed and tested. All 15 interlinked ESR projects have an interdisciplinary component (intersection of sepsis research, product development, economics and medical practice) and international (representing 10 countries) and industry collaborations (incorporating 3 diagnostics firms, 1 bioinformatics company and a business school). Interactions within the network are strengthened by meaningful secondments, which take place at private beneficiary or partner institutes. The training programme covers: 1. Specialist training in an international, interdisciplinary and intersectorial sepsis-orientated research project; 2. Advanced technology training in pathogenesis, biomarker discovery, diagnostics, trial design and innovation management; 3. Professional training in transferable skills, including the special ESA-ITN mini-MBA. The setup of ESA-ITN is unique as it reflects the entire innovation value chain for sepsis biomarker diagnostics. ESA-ITN is composed of leading institutes in sepsis research and a selection of Europes top biomarker diagnostics companies. Links to various global networks and shared research infrastructures in the field of sepsis further leverage the proposition of ESA-ITN.