The scale of micro- and nanoplastic (MNP) pollution is becoming increasingly clear yet little is known about how this pollution impacts health. The AURORA project will deliver an actionable European roadmap for early-life health risk assessment of MNPs to support regulation of MNPs and the products and processes that generate secondary MNPs, and development of safer alternatives. We will focus on MNP exposures and toxicological and health effects during pregnancy, in utero, and in early life. These periods are critical for development and health later in life and are of heightened vulnerability to environmental insults. We have recently shown that MNPs are likely to cross the placental barrier in vitro and in vivo, underlying the urgent need to understand the impact of MNPs on reproductive and early-life health. AURORA will do so by significantly enhancing exposure assessment capabilities for measuring MNPs and MNP-associated chemicals (e.g. additives) in tissues relevant for early-life development (placenta, cord blood, amniotic fluid, meconium, fetal tissue). It will take a unique approach by combining in-depth characterization methods (microscopy and spectroscopy) and scalable methods (mass-spectrometry) to develop methods for both detailed and large-scale toxicological, exposure assessment, and epidemiological studies. This will be combined with a novel tiered-testing approach and epidemiological investigations to provide the first extensive evaluation of maternal and fetal MNP exposures and health perturbations, including placental function, immune-inflammatory responses, oxidative stress, accelerated aging, endocrine disruption, and child development. In the course of developing and applying the tools and methodological workflows of the AURORA research program, we will create a risk assessment framework specific to MNPs and identify the remaining knowledge gaps and priorities needed for comprehensively evaluating the impact of MNPs on early-life health. AURORA is part of the European MNP cluster on human health.

The HIV/AIDS pandemic continues to be one of the major health challenges ever faced by mankind. Far from being resolved, HIV is soaring in Eastern Europe (60% increase in new infections and 27% increase in deaths since 2010) and other regions of the world despite increasing access to antiretroviral treatment. There is emerging evidence that the human microbiome impacts some of the most important clinical aspects of HIV-1 infection, including immune disorders, chronic inflammation and accelerated aging. Work in other viral diseases and cancer immunotherapy suggest a critical role of the human microbiome also in the outcome of immune therapeutic interventions in HIV-1 infection. The MISTRAL project brings together a team of world-class HIV and microbiome researchers and SMEs with ideal complementary knowledge and expertise. This team will work to discover and validate novel gut microbiome biomarkers to inform rationally-designed, mechanistically-driven interventions on the gut microbiome to mitigate HIV-1 acquisition, systemic inflammation, chronic clinical complications, antimicrobial drug resistance, and boost the efficacy of HIV cure immunotherapies. Integrated and curated large microbiome and host datasets generated during the execution of the project will be made public through a freely accessible, specifically-dedicated web-based repository. Biomarker discoveries will be incorporated into a cloud-based software tool that will automate microbiome analyses and interpretations, thus streamlining patient stratification for clinical and research purposes. If successful, MISTRAL will benefit millions of human beings living with, or at risk of acquiring HIV-1 infection, and will produce novel concepts and technical innovations applicable to other human diseases. By doing that, MISTRAL will help to unlock the full clinical potential of the human microbiome to stratify patient outcomes and will irreversibly bring microbiome science closer to clinical practice.

The proposal, VSV-EBOVAC, directly addresses the topic 1 of the IMI2 call on Ebola by supporting the clinical development of a highly promising new Ebola vaccine candidate, the vesicular stomatitis virus (VSV)‐ vectored Zaire Ebola vaccine (VSV-ZEBOV). In non-human primates, a single dose of VSV-ZEBOV elicited a strong (100%) and long-lasting protective efficacy against Ebola Zaire infections. Developed by Public Health Canada and manufactured by NewLink Genetics, VSV-ZEBOV was thus selected by the World Health Organization (WHO) as one of the 2 most promising vaccine candidates. To accelerate its clinical development, the WHO has organized a consortium and supported the organization of parallel first-in-man Phase I/II clinical trials, both in Europe and Africa. The primary objectives of these trials, initiated mid-November 2014, are to study the safety and antibody-inducing capacity of various doses of VSV-ZEBOV in European and African populations. We propose to build upon this asset to acquire new and critical knowledge of the innate and adaptive immune responses elicited in humans by VSV-ZEBOV vaccination, with specific emphasis on trancriptomics and metabolomics signatures. To this aim, we have constructed a consortium including representatives from the vaccine manufacturer, scientists of the 3 main clinical sites (Switzerland, Gabon, Kenya) and world-leaders in immunology and partners of ADITEC, a large FP7- supported collaborative research programme aiming to accelerate the development of novel, powerful immunisation technologies for next-generation vaccines. We propose an ambitious program using cutting-edge technologies to perform an in depth characterization of the clinical samples harvested before/after VSV-ZEBOV immunization of 200 volunteers in Switzerland, Gabon and Kenya, and to extend the recently initiated clinical studies up to 12 months to identify the signatures and determinants of persistent immune responses.

By 2030 more than 80% of Europe’s population will live and interact with a complex urban environment, consisting of a mixture of social and environmental factors. These factors include: where we live and work, where and what we eat, our social network, and what chemical substances we are exposed to. Individually or collectively these factors, known as the Urban Exposome, have an often modifiable impact on our health and provide important targets to improve population health. By studying the impact of the Urban Exposome on the major contributors to Europe’s burden of disease: Cardio-Metabolic and Pulmonary Disease, EXPANSE will address one of the most pertinent questions for urban planners, policy makers, and European citizens: “How to maximize one’s health in a modern urban environment?”. EXPANSE will take the next step in Exposome research by: 1) bringing together the Exposome and health data of more than 55 million Europeans in administrative cohorts, in-depth Exposome, phenotype, and OMICs information for more than 2 million Europeans, and personalized Exposome assessment for 4,000 individuals living in five “Urban Labs”; 2) applying a novel approach to use ultra-high-resolution mass-spectrometry to agnostically screen for exogenous chemicals in 10,000 blood samples; 3) studying the evolution of the Exposome and health through the life-course via both (matured) birth and adult cohorts; and 4) evaluating the impact of changes in the Urban Exposome on the burden of Cardio-Metabolic and Pulmonary Disease. EXPANSE will translate its insights and innovations into research and dissemination tools that will be openly accessible via the EXPANSE toolbox. By applying innovative ethics-by-design throughout the project, the social and ethical acceptability of these tools will be safeguarded. Tool discoverability and accessibility will be stimulated through the EXPANSE hub in which citizens, public sector policy makers, and private sector companies collectively participate. EXPANSE is part of the European Human Exposome Network comprised of 9 projects selected from this same call