Work Packages

HEDIMED includes 13 Work Packages (WPs) which communicate with each other to produce a fluent flow of information. This starts with the harmonisation of data from clinical cohorts and extends to the wide range of different analyses of the samples collected in these cohorts. Various stakeholders interact to implement the generated new knowledge.

Individual WPs are dedicated to the analysis of the internal, specific external and general external exposomes as well as the creation of new analytical methods, cell and organoid modelling and new tools for scientific research, prediction of disease risk, development of preventive treatments and estimation of the socioeconomic impacts of such interventions. These tools are available for different stakeholders via the HEDIMED toolbox on the internet.

Ethics and data protection are covered by WP3 and WP13 that run throughout the project.

HEDIMED participates in the larger European Human Exposome Network through WP 12.

  • WP1 – Administration 
  • WP2 – Creation of harmonized data and sample resource of clinical cohorts
  • WP3 – Ethics and protection of personal data 
  • WP4 – Characterization of the specific external environment 
  • WP5 – Characterization of the general external environment 
  • WP6 – Characterization of the internal environment 
  • WP7 – Intelligent sensoring and new technologies
  • WP8 – Exposomic signatures in cell and organoid models
  • WP9 – Identification of exposome-disease associations 
  • WP10 – Creation of Exposome Data Analysis and Modelling Toolbox
  • WP11 – Dissemination and exploitation 
  • WP12 – European Human Exposome Network Activities 
  • WP13 – Ethics requirements
  • WP1
  • WP2
  • WP3
  • WP4
  • WP5
  • WP6
  • WP7
  • WP8
  • WP9
  • WP10
  • WP11
  • WP12
  • WP13

Administration

Objectives: 

  • To establish an operational management structure to ensure efficient communication between the partners in HEDIMED, as well as to efficiently communicate with the European Commission and different stakeholders. 
  • To set up a management team to assist and advice the HEDIMED partners regarding administration and reporting and to produce necessary reports. 
  • To ensure effective implementation of the project in line with guidelines from the Commission, the Project Contract and the Consortium Agreement. 
  • To identify potential problems at an early stage and provide timely and effective solutions (risk management). 
  • To facilitate efficient dissemination and exploitation efforts in collaboration with all partners. 

Creation of harmonized data and sample resource of clinical cohorts

WP2 will create a representative data and sample series for the work carried out in other WPs.

Objectives:

  • Collection of existing data from different clinical cohorts in a uniform form, and generation of new data to create a harmonized data matrix. 
  • Defining and setting the criteria for the study endpoints type 1 diabetes, celiac disease, asthma, specific IgE sensitization, atopic dermatitis, and allergic rhinitis. 

Ethics and protection of personal data 

Objectives: 

  • To monitor the compatibility of the carried analyses with ethical and personal protection regulation. 
  • To develop procedures that guarantee the protection of personal data and the privacy of individuals. 
  • Close interaction with WP13. 

Characterization of the specific external environment 

Objectives: 

  • To characterize the microbiome of children and pregnant mothers and to characterize the infections encountered during pregnancy and in early childhood. 
  • To characterize the immune system response to the commensal microflora in pregnant women and babies using blood and faecal samples of studied subjects. 
  • To characterise intestinal mucosa leakage using serum markers. 
  • To characterize the in utero and postnatal exposure of the child to environmental toxicants. To characterize exposure to various dietary compounds in utero and postnatally. 
  • To collect information about the anxiety and stress of pregnant women and babies using continuous monitoring and sampling of individuals. 
  • To characterize the physical activity of pregnant women and young children using continuous monitoring of individuals. 

Characterization of the general external environment 

Objectives: 

  • To characterize the nature of the environment where the child has lived during the in utero period and during the first year of life using earth observation data and derived land cover and atmospheric variables. 
  • To characterize the microbiota of the child’s living environment including home indoor environment and outdoor environment. 
  • To characterize the presence of toxicants in the child’s living environment. 
  • To characterize the connections between environmental toxicants and commensal microbiota. 

Characterization of the internal environment 

WP6 aims to carry out extensive profiling of child´s internal environment covering the in utero-period and the postnatal follow-up and to use advanced modelling and data mining approaches to identify interactions between external exposures and the internal environment, and thereby to find phenotypic changes that associate with IMDs. 

 Objectives: 

  • Characterization of circulating serum proteome, cytokinome and miRNAs. 
  • Studies on the epigenetic changes and transcriptional activity of different genes in circulating immune cells. 
  • Characterization of circulating exposomes. 
  • Metabolomics analysis of stool samples. 
  • Studies on antigen receptor specificity in circulating lymphocytes. 

Intelligent sensoring and new technologies 

WP7 aims to create novel tools for human exposome studies and distribute these technologies widely to the science community to facilitate the research in this field.  

Objectives: 

  • High throughput Immunosignature tool for characterizing antibody responses. 
  • Portable multiarray system for immunosignature testing. 
  • Microbial subtyping tool. 
  • Portable tool for continuous monitoring of VOC (volatile organic compound) exposure. 

Exposomic signatures in cell and organoid models 

WP8 aims to verify intra-, extra- and intercellular signatures that are characteristic for disease-associated exposomic determinants using cell and organoid models. 

Objectives: 

  • To correlate experimental signatures to internal exposomic signatures observed in clinical cohorts. 

Identification of exposome-disease associations 

WP9 aims to identify biologically relevant and most likely causal exposome-disease associations. This is done using a novel multidisciplinary approach combining the work carried out in all WPs and the largest series of prospectively followed children who have developed immune-mediated diseases ever studied for the exposomic determinants of these diseases. 

Objectives: 

  • To identify exposomic determinants that modulate the risk of certain IMD. 
  • To identify exposomic determinants that are common to several IMDs. 
  • Compute accuracy, sensitivity and specificity metrics for the exposome toolbox models. 

Creation of Exposome Data Analysis and Modelling Toolbox 

WP10 aims to develop tools for the analysis of the complex exposome data and for the identification dominating and modulating exposome-disease pathways using a global exploratory approach to model the relations between different associations and to identify biological pathways which most strongly predict the development of immune-mediated diseases. Also, specific exposures that have been associated with the study outcomes in these clinical cohorts in previous studies (or in studies carried out in other cohorts) will be included in these models (e.g. respiratory infections, enterovirus infections, rhinovirus infections, certain phospholipids, omega-3 fatty acids, gluten intake, breastfeeding, gut dysbiosis, exposure to high environmental microbial diversity, maternal virus antibodies, etc.).  

This WP will provide a practical data analysis toolbox which includes validated methods for the analyses of complex exposome data and which can be used widely by the science community. 

Objectives: 

  • To set up HEDIMED data analysis platform (EDAMT).  
  • To connect cohort datasets and external datasets to HEDIMED data analysis platform. 
  • To design and implement methods for data fusion, analysis and visualization. 
  • To design and implement interactive methods for exposome simulations for decision-makers. 
  • To design and implement user interfaces for researchers, decision-makers and citizens. 
  • To give technical support for the project on the use of EDAMT. 

Dissemination and exploitation 

Objectives: 

  • To inform and get feedback on the toolbox from different stakeholders and end-users. 
  • To develop the toolbox in close interactions with the end-users. 
  • To disseminate the results of HEDIMED widely to the society, industry and science community. 
  • To communicate the results and accomplishments of HEDIMED widely to the society to improve public awareness of immune-mediated diseases, the quality of science and the care of patients, and to give practical tools for the political decision-making process in EU countries. 
  • To facilitate the development of new products for the prevention and treatment of immune-mediated diseases and diagnostic tests for early diagnostics and prediction of immune-mediated diseases. 

European Human Exposome Network Activities 

Objectives: 

  • Establish a European Human Exposome Network (EHEN) comprising all projects funded from the call ‘SC1-BHC-28-2019: The Human Exposome Project: a toolbox for assessing and addressing the impact of the environment on health’ and implement joint actions. 
  • Set up an external Network Advisory Board (NAB), providing strategic advice to the network. 
  • Develop and implement a common communication and dissemination strategy for the European Human Exposome Network. 
  • Develop and implement a joint strategy on how scientific evidence can be translated into policy. 
  • Organise periodic meetings (‘conferences’) of the European Human Exposome Network. 
  • Establish joint working groups on topics of interest. 

 

EHEN website 

Ethics requirements 

Objectives: 

  • The objective is to ensure compliance with the 'ethics requirements' set out in this work package. 
  • Close interaction with WP3. 

Administration

Objectives: 

  • To establish an operational management structure to ensure efficient communication between the partners in HEDIMED, as well as to efficiently communicate with the European Commission and different stakeholders. 
  • To set up a management team to assist and advice the HEDIMED partners regarding administration and reporting and to produce necessary reports. 
  • To ensure effective implementation of the project in line with guidelines from the Commission, the Project Contract and the Consortium Agreement. 
  • To identify potential problems at an early stage and provide timely and effective solutions (risk management). 
  • To facilitate efficient dissemination and exploitation efforts in collaboration with all partners. 

Creation of harmonized data and sample resource of clinical cohorts

WP2 will create a representative data and sample series for the work carried out in other WPs.

 

Objectives:

  • Collection of existing data from different clinical cohorts in a uniform form, and generation of new data to create a harmonized data matrix. 
  • Defining and setting the criteria for the study endpoints type 1 diabetes, celiac disease, asthma, specific IgE sensitization, atopic dermatitis, and allergic rhinitis. 

Ethics and protection of personal data 

Objectives: 

  • To monitor the compatibility of the carried analyses with ethical and personal protection regulation. 
  • To develop procedures that guarantee the protection of personal data and the privacy of individuals. 
  • Close interaction with WP13. 

Characterization of the specific external environment 

Objectives: 

  • To characterize the microbiome of children and pregnant mothers and to characterize the infections encountered during pregnancy and in early childhood. 
  • To characterize the immune system response to the commensal microflora in pregnant women and babies using blood and faecal samples of studied subjects. 
  • To characterise intestinal mucosa leakage using serum markers. 
  • To characterize the in utero and postnatal exposure of the child to environmental toxicants. To characterize exposure to various dietary compounds in utero and postnatally. 
  • To collect information about the anxiety and stress of pregnant women and babies using continuous monitoring and sampling of individuals. 
  • To characterize the physical activity of pregnant women and young children using continuous monitoring of individuals. 

Characterization of the general external environment 

Objectives: 

  • To characterize the nature of the environment where the child has lived during the in utero period and during the first year of life using earth observation data and derived land cover and atmospheric variables. 
  • To characterize the microbiota of the child’s living environment including home indoor environment and outdoor environment. 
  • To characterize the presence of toxicants in the child’s living environment. 
  • To characterize the connections between environmental toxicants and commensal microbiota. 

Characterization of the internal environment 

WP6 aims to carry out extensive profiling of child´s internal environment covering the in utero-period and the postnatal follow-up and to use advanced modelling and data mining approaches to identify interactions between external exposures and the internal environment, and thereby to find phenotypic changes that associate with IMDs. 

 

Objectives: 

  • Characterization of circulating serum proteome, cytokinome and miRNAs. 
  • Studies on the epigenetic changes and transcriptional activity of different genes in circulating immune cells. 
  • Characterization of circulating exposomes. 
  • Metabolomics analysis of stool samples. 
  • Studies on antigen receptor specificity in circulating lymphocytes. 

Intelligent sensoring and new technologies 

WP7 aims to create novel tools for human exposome studies and distribute these technologies widely to the science community to facilitate the research in this field. 

Objectives: 

  • High throughput Immunosignature tool for characterizing antibody responses. 
  • Portable multiarray system for immunosignature testing. 
  • Microbial subtyping tool. 
  • Portable tool for continuous monitoring of VOC (volatile organic compound) exposure. 

Exposomic signatures in cell and organoid models 

WP8 aims to verify intra-, extra- and intercellular signatures that are characteristic for disease-associated exposomic determinants using cell and organoid models. 

 

Objectives: 

  • To correlate experimental signatures to internal exposomic signatures observed in clinical cohorts. 

Identification of exposome-disease associations 

WP9 aims to identify biologically relevant and most likely causal exposome-disease associations. This is done using a novel multidisciplinary approach combining the work carried out in all WPs and the largest series of prospectively followed children who have developed immune-mediated diseases ever studied for the exposomic determinants of these diseases. 

 

Objectives: 

  • To identify exposomic determinants that modulate the risk of certain IMD. 
  • To identify exposomic determinants that are common to several IMDs. 
  • Compute accuracy, sensitivity and specificity metrics for the exposome toolbox models. 

Creation of Exposome Data Analysis and Modelling Toolbox 

WP10 aims to develop tools for the analysis of the complex exposome data and for the identification dominating and modulating exposome-disease pathways using a global exploratory approach to model the relations between different associations and to identify biological pathways which most strongly predict the development of immune-mediated diseases.

 

Also, specific exposures that have been associated with the study outcomes in these clinical cohorts in previous studies (or in studies carried out in other cohorts) will be included in these models (e.g. respiratory infections, enterovirus infections, rhinovirus infections, certain phospholipids, omega-3 fatty acids, gluten intake, breastfeeding, gut dysbiosis, exposure to high environmental microbial diversity, maternal virus antibodies, etc.).  

 

This WP will provide a practical data analysis toolbox which includes validated methods for the analyses of complex exposome data and which can be used widely by the science community. 

 

Objectives: 

  • To set up HEDIMED data analysis platform (EDAMT).  
  • To connect cohort datasets and external datasets to HEDIMED data analysis platform. 
  • To design and implement methods for data fusion, analysis and visualization. 
  • To design and implement interactive methods for exposome simulations for decision-makers. 
  • To design and implement user interfaces for researchers, decision-makers and citizens. 
  • To give technical support for the project on the use of EDAMT. 

Dissemination and exploitation 

Objectives: 

  • To inform and get feedback on the toolbox from different stakeholders and end-users. 
  • To develop the toolbox in close interactions with the end-users. 
  • To disseminate the results of HEDIMED widely to the society, industry and science community. 
  • To communicate the results and accomplishments of HEDIMED widely to the society to improve public awareness of immune-mediated diseases, the quality of science and the care of patients, and to give practical tools for the political decision-making process in EU countries. 
  • To facilitate the development of new products for the prevention and treatment of immune-mediated diseases and diagnostic tests for early diagnostics and prediction of immune-mediated diseases. 

European Human Exposome Network Activities 

Objectives: 

  • Establish a European Human Exposome Network (EHEN) comprising all projects funded from the call ‘SC1-BHC-28-2019: The Human Exposome Project: a toolbox for assessing and addressing the impact of the environment on health’ and implement joint actions. 
  • Set up an external Network Advisory Board (NAB), providing strategic advice to the network. 
  • Develop and implement a common communication and dissemination strategy for the European Human Exposome Network. 
  • Develop and implement a joint strategy on how scientific evidence can be translated into policy. 
  • Organise periodic meetings (‘conferences’) of the European Human Exposome Network. 
  • Establish joint working groups on topics of interest.

 

EHEN website 

Ethics requirements 

Objectives: 

  • The objective is to ensure compliance with the 'ethics requirements' set out in this work package. 
  • Close interaction with WP3.