Description of PROMISE Work Packages, their objectives and structure. The PROMISE Work Packages are the areas of work that the PROMISE study covers. The Work Packages are overseen by the PROMISE Ethics, Patient and International Scientific Advisory Boards. More information about our Advisory Boards. Work Package Objectives Expand all Collapse all WP1 - RSV epidemiology and impact of COVID-19 Conduct large scale systematic literature reviews to consolidate all available published and unpublished data at global level to inform RSV burden in pregnant women and infants, and synthesise evidence to inform development of severity scores for RSV infection. Model the impact of COVID-19 on health-care utilisation for RSV using national and regional routine healthcare data. Evaluate the impact of COVID-19 on RSV seasonality. Model the cost-effectiveness of RSV vaccination in older adults aged 65 years post COVID-19. WP2 - Preparation of future RSV product assessment Establish a reporting platform to collect detailed age-specific weekly surveillance data across the EU. Publish a Fortnightly Electronic Bulletin on RSV activity on an agreed website (year 1 as a pilot and year 2 as an open publication). Establish harmonised laboratory methods and approaches to detect and report RSV activity in Europe. Establish clinical endpoints to measure effectiveness and safety of RSV vaccines. Explore and develop different study designs to measure product effectiveness and safety. Enhance science-based communication between regulatory and public health agencies (e.g. EMA, ECDC, and national public health agencies). Foster and promote patient engagement activities and citizen science in RSV prevention related issues. WP3 - Clinical validation studies Establish the relationship between infant RSV infection and wheeze/asthma in school age children. Update and validate RSV severity scores, including the ReSViNET score, used in registration trials of RSV therapeutics during infancy. Establish a biobank for confirmatory biomarker studies. Analyse time trends of RSV-related admissions in relation to the COVID-19 pandemic. WP4 - Biomarker identification validation Identify mucosal correlates for disease severity in paediatric RSV infection and validate correlates identified from peripheral blood in samples from the respiratory site of disease. Confirm the most relevant RESCEU biomarkers associated with RSV infection susceptibility by performing functional analyses of the respiratory and gut microbiomes in order to identify potential underlying mechanisms and translate this scientific knowledge into concrete applications for RSV patients. Build upon RESCEU data by confirming the suitability of RSV-specific serum IgA as a biomarker of prior wild type (WT) RSV experience in infants and further investigate interference by maternal antibodies. WP5 - Project Coordination, management and sustainability Coordinate and steer all project activities, promoting strategic direction, alignment and achievement of the project goals. Set-up a project management structure that ensures efficient operational execution of the project, including administrative support, financial allocation/reporting, legal issues, and organisation of project meetings. Ensure project implementation according to the work plan, including timely delivery of results, link and workflow between WPs, with an adequate quality level and within cost, including risk management and quality control procedures on deliverables. Promote effective internal communication and knowledge management and work dynamics between participants. Develop data visualisation solutions of the outputs generated in PROMISE to ensure awareness and sustainability of the assets for the for the global community. Develop an external communication plan to disseminate and promote PROMISE results to external stakeholders, including data visualisation solutions. Provide an efficient plan and foresight to guarantee the project sustainability. Coordinate and ensure the correct strategic alignment between the RESCEU and PROMISE projects, including ethical oversight and Public Private Partnership (PPP) governance. WP6 - Ethics requirements Ensure compliance with the ethics requirements set out for the project. Work Package Structure Image This article was published on 2024-09-24