PROMISE Deliverables Expand all Collapse all D4.7 Scientific report of combined multiomics analysis Main Author Jim Janimak (18 – GSK) Work Package WP4 – Task 4.2 Biomarker Identification Validation in a Prospective Observational Case-Control Study Document PROMISE D4.7 Scientific report of combined multiomics analysis (2.68 MB / 7_SCIENTIFIC_REPORT_OF_COMBINED_MULTI-OMICS_ANALYSIS_V1) July 2024 2.9 Generic protocols for post-authorisation safety studies of preventive products against RSV Main Author Odette de Bruin (2 – UMCU) Fariba Ahmadizar (2 – UMCU) Miriam Sturkenboom (2 – UMCU) Work Package WP2 – Preparation for future RSV product assessment Document PROMISE2.9 Generic protocols for postauthorisation safety studies of preventive products against RSV (1.02 MB / 9_GENERIC_PROTOCOLS_SAFETY_IN_PREGNANCY_AND_OLDER_ADULTS_V1) July 2024 D1.8 Modelled impact of COVID-19 on RSV seasonality in Europe Main Author Susanne Heemskerk (8 - NIVEL) Work Package WP1 – RSV epidemiology and impact of COVID-19 Document PROMISE D1.8 Modelled impact of COVID-19 on RSV seasonality in Europe (1.41 MB / 8_MODELLED_IMPACT_OF_COVID-19_ON_RSV_SEASONALITY_IN_EUROPE) July 2024 D1.7 Report on impact of COVID-19 and COVID-19 NPIs on RSV healthcare burden Main Author Harry Campbell (1 - UEDIN) Work Package WP1 – RSV epidemiology and impact of COVID-19 Document PROMISE D1.7 Report on impact of COVID-19 and COVID-19 NPIs on RSV healthcare burden (2.18 MB / 7_REPORT_ON_IMPACT_OF_COVID-19_AND_COVID-19_NPIS_ON_RSV_HEALTHCARE_BURDEN_V1) July 2024 D1.6 RSV healthcare burden in young children and the elderly in 6 European countries before and since the emergence of the COVID-19 pandemic Main Author Harry Campbell (UEDIN - The University of Edinburgh) Work Package WP1 – WP RSV Epidemiology and Impact of COVID-19 Document PROMISE D1.6 RSV healthcare burden in young children and the elderly in 6 European countries before and since the emergence of the COVID-19 pandemic (4.64 MB / PDF) July 2024 D2.12 Final Progress Report Task 2.2 Description Task 2.2 of Work Package 2 focused on the establishment of the RSV Laboratory Network (RSV LabNet), the standardisation/harmonisation of priorities, protocols, and ultimately the hand-over of progress and activities to the European Centre for Disease Prevention and Control (ECDC). Main Author Adam Meijer (7 - RIVM) Work Package WP2 - Preparation of future RSV product assessment Document PROMISE D2.12 – Final Progress Report Task 2.2 (300.13 KB / 12_FINAL-PROGRESS-REPORT-T2) April 25, 2024 D2.4 Report on identification of adverse events for safety evaluations of RSV vaccination and monoclonal antibodies Description This study, conducted as part of Work Package 2 (WP2) within the PROMISE Consortium, focuses on preparing for the post-licensure safety evaluation of respiratory syncytial virus (RSV) vaccines and monoclonal antibodies (mAbs). The objective is to identify adverse events of special interest (AESIs) for safety assessments in various vaccine target age groups, including infants, children, pregnant women, adults, and older adults (≥60 years). Main Author Anders Hviid (12–SSI), Kristyna Faksova (12–SSI), Lydie Marcelon (17–SP), David Neveu (17–SP) Work Package WP2 - Preparation of future RSV product assessment Document PROMISE D2.4 Report on identification of adverse events for safety evaluations of RSV vaccination and monoclonal antibodies (1.44 MB / 4-ADVERSE-EVENTS-FOR-SAFETY-EVALUATIONS_V1) April 25, 2024 D2.8 Identification of methodological challenges Description There are several potential methodological challenges that may complicate the set up and implementation of post marketing studies on effectiveness and safety of Respiratory Syncytial Virus (RSV) preventive products (i.e., vaccines and monoclonal antibodies) or the interpretation of their results. These include bias and confounding, sample size considerations, access to these preventive products, access to health care and varying degrees of clinical testing of RSV, heterogeneity in case definitions, data availability and access to data, and challenges specific to certain target groups of RSV immunisation. While it is seldom possible to eliminate all potential challenges that threaten the feasibility or validity of an RSV impact study, many of them can be mitigated through careful choices at the study design level. Main Author Topi Turunen (6 – THL) Work Package WP2 - Preparation of future RSV product assessment Document PROMISE D2.8 Identification of methodological challenges (233.28 KB / 8_IDENTIFICATION-OF-METHODOLOGICAL-CHALLENGES_V1) April 8, 2024 D1.5 Report on global impact of COVID-19 on RSV burden Description We conducted a systematic literature review to identify and include published data on RSV-associated ALRI hospitalisation burden in children younger than 5 years during the COVID-19 period; we supplemented the published data by further including more granular unpublished RSV epidemiology data shared by RSV GEN collaborators. We conducted a series of generalised linear mixed-effects meta-analyses to compare age-specific annualised RSV-associated ALRI hospitalisation rates, age distribution and disease severity between pre-pandemic and pandemic periods, separately by country income region. Main Author Bingbing Cong (Nanjing Medical University) Work Package WP1 - RSV epidemiology and impact of COVID-19 Document PROMISE D1.5 Report on understanding the disease burden of respiratory syncytial virus in young children after the start of the COVID-19 pandemic (2.62 MB / 5_REPORT-ON-GLOBAL-IMPACT-OF-COVID-19-ON-RSV-BURDEN_V1) April 8, 2024 D1.3 Report on RSV burden in pregnant women Description We conducted a systematic review following PRISMA 2020 guidelines using five databases (Medline, Embase, Global Health, Web of Science and Global Index Medicus) and included additional unpublished data. Pregnant individuals with respiratory infections who had respiratory samples tested for RSV were included. We used a random-effects meta-analysis to generate overall proportions and rate estimates across studies. Main Author Harish Nair (1 – UEDIN) Work Package WP1 - RSV epidemiology and impact of COVID-19 Document PROMISE D1.3 Report on RSV burden in pregnant women (1.58 MB / 3_REPORT-ON-RSV-BURDEN-IN-PREGNANT-WOMEN_V1) April 8, 2024 D1.2 Report on variation in global RSV seasonality by subtypes Description We compiled published data through conducting a systematic literature review, plus unpublished data shared by the Respiratory Virus Global Epidemiology Network (RSV GEN) and the Global Epidemiology of RSV in Community and Hospitalised Care (GERi) project. Main Author Shuyu Deng (Nanjing Medical University) Work Package WP1 - RSV epidemiology and impact of COVID-19 Document PROMISE D1.2 Report on variation in global RSV seasonality by subtypes (5.55 MB / 2_REPORT-ON-VARIATION-IN-GLOBAL-RSV-SEASONALITY-BY-SUBTYPES_V1) April 8, 2024 D1.1 Report on novel clinical scores for RSV severity Description We conducted a systematic review of English-language publications in peer-reviewed journals published since 2000 assessing the validity of severity scores for children (≤24 months) with RSV and/or bronchiolitis and identified the most promising scores Main Author Harish Nair (1- UEDIN) Work Package WP1 - RSV epidemiology and impact of COVID-19 Document PROMISE D1.1 Report on novel clinical scores for RSV severity (1.32 MB / 1_REPORT-ON-NOVEL-CLINICAL-SCORES-FOR-RSV-SEVERITY_V2) April 8, 2024 D3.7 Report on status of posting results Description PROMISE Work Package (WP) 3 (clinical validation studies) includes 2 clinical studies which aim to generate data in children. Data collection and analysis of results of both studies are currently ongoing. For both studies follow-up and data generation is still ongoing and will continue until (or beyond) the PROMISE project end date (i.e., 30 April 2024). Results/(meta)data of these studies will be made accessible according to the FAIR (Findable, Accessible, Interoperable and Reusable) principles, either as an addition to the RESCEU Elixir LU platform/repository which is used for the RESCEU clinical studies or on another reliable repository. This will be done together with or following publication of the manuscripts describing the main results of both PROMISE clinical studies. Main Author Joanne G. Wildenbeest (2 – UMCU) Work Package WP3 - Clinical validation studies (Prospective studies) Document PROMISE D3.7 Report on status of posting results (145.66 KB / 7_REPORT-ON-STATUS-OF-POSTING-RESULTS_V1) D3.6 Samples will be ready for shipment to WP4 partners with optimal conditions for storage and shipment Description The PROMISE case-control validation study (study 2) is a prospective monocenter study conducted at UMC Utrecht. The main objective of this study is to validate biomarkers for severity of RSV disease in infants identified in the RESCEU infant studies. The study started in November 2021. Until now biological samples and clinical information have been collected from 102 previously healthy infants (<1 year of age) sub-divided into different groups specified in the deliverable. Main Author Joanne G. Wildenbeest (2 – UMCU) Work Package WP3 - Clinical validation studies (Prospective studies) Document PROMISE D3.6 Samples will be ready for shipment to WP4 partners with optimal conditions for storage and shipment (341.61 KB / 6_SAMPLES-WILL-BE-READY-FOR-SHIPMENT_V1) November 8, 2023 D2.10 Report on the impact of the annual RSV awareness campaign in November 2022 Description This report provides a comprehensive overview of the second annual RSV AW as part of the PROMISE project, organised by the ReSViNET RSV Patient Network, titled “Share to be Aware“, held from November 4-10, 2022. The report explores activities conducted during RSV AW’22 and evaluates their impact, with a particular focus on the effectiveness of various social media campaigns across multiple platforms. Main Author Lies Kriek (11 - ReSViNET) Work Package WP2 - Preparation for future RSV product assessment Document PROMISE D2.10 Report on the impact of the annual RSV awareness campaign in November 2022 (580.86 KB / 10_REPORT-ON-IMPACT-OF-RSV-AWC-NOV2022_V1) November 8, 2023 D3.5 Mid-term recruitment report for Study 2 (PROMISE case-control validation study) Description The PROMISE case-control validation study (study 2) is a prospective monocenter study conducted at UMC Utrecht. The objectives of this study are to validate biomarkers for severity of respiratory syncytial virus (RSV) disease in infants found in the RESCEU infant studies and to validate a new severity score developed by WP1. Main Author Joanne G. Wildenbeest (2 – UMCU) Work Package WP3 - Clinical validation studies (Prospective studies) Document PROMISE D3.5 Midterm recruitment report for Study 2 (PROMISE case-control validation study) (286.78 KB / 5_MIDTERM-RECRUITMENT-REPORT-FOR-STUDY-2_V1) September 21, 2023 D3.4 Final study approvals package for Study 1 and 2 Description The protocol and additional documentation of the 2 clinical studies of Work Package (WP) 3 have been designed in close collaboration with WP2 and WP4 partners. Study 1 is the PROMISE follow-up study and consists of extended follow-up of eligible infants of the RESCEU infant cohort study and the RESCEU infant case-control study with the aim to evaluate the incidence of asthma/wheeze at the age of 6 years in relation to RSV infection of different severity levels. Study 2 is the PROMISE case-control biomarker validation study. This study has the aims to validate the biomarkers found in the RESCEU infant studies and to validate a new severity score developed by WP1 and will be performed at UMC Utrecht. Main Author Joanne G. Wildenbeest (2 – UMCU) Work Package WP3 - Clinical validation studies (Prospective studies) Document PROMISE D3.4 Final study approvals package for Study 1 and 2 (453.91 KB / 4_FINAL-STUDY-APPROVALS-PACKAGE-FOR-STUDY-1-AND-2_V1) September 21, 2023 D2.1 Open-access online tool to continuously measure RSV awareness Description Understanding public awareness of RSV is important to support preventive interventions and educational activities. To effectively address this issue, it is crucial to measure public awareness of RSV and provide support through preventive measures and educational initiatives. Main Author ReSViNET Work Package WP2 - Preparation of future RSV product assessment Document PROMISE D2.1 Open-access online tool to continuously measure RSV awareness (438.77 KB / 1_ONLINE-AWARENESS-TOOL-REPORT_V1) September 21, 2023 D2.6 Generic protocols for effectiveness studies of preventive products against RSV Description Understanding the real-life effectiveness of RSV products is of major public health importance. The PROMISE Consortium has developed two protocols for observational studies to assess preventive product (monoclonal antibody or vaccine) effectiveness: one using the test-negative design, the other, for cohort studies using electronic databases. These outputs are intended as generic protocols which can be adapted to specific settings and modified to account for local data availability. Main Author THL - RIVM Work Package WP2 – Preparation for future RSV product assessment Document PROMISE D2.6 Generic protocols for effectiveness studies of preventive products against RSV (774.52 KB / 6_GENERIC-PROTOCOLS-FOR-EFFECTIVENESS-STUDIES_V1) July 6, 2023 D2.5 Report on consultations with Health Authorities on data elements needed for Phase IV studies Description Understanding the efficacy, effectiveness, and safety of RSV preventive products (i.e., monoclonal antibodies and vaccines) is relevant to a wide variety of health authorities, from regulators to public health institutes and international health agencies. The PROMISE Consortium has undertaken consultations with public health stakeholders about their data needs when getting ready to make decisions on the introduction of new RSV preventive products. The Consortium’s outputs that in particular have been subjected to external review are the evaluation of clinical endpoints in RSV studies and the generic product effectiveness study protocols. In conclusion, consultations with health authorities have resulted in important feedback. Given that many member states have not yet decided how RSV products will be assessed and that it will take time before PROMISE’s generic research protocols can be applied in practice, further consultations may be necessary in the future, possibly even during the remaining contract period of the PROMISE Consortium. Main Author THL Work Package WP2 – Preparation for future RSV product assessment Document PROMISE D2.5 Report on consultations with Health Authorities on data elements needed for Phase IV studies (473.47 KB / 5-REPORT-ON-CONSULTATIONS-WITH-HA_V1) July 6. 2023 D3.3 Full institutional review board (IRB) approval Description The infant case-control validation study has been designed in close collaboration with Work Package (WP) 4 partners. This monocenter study will take place at UMC Utrecht. The protocol and additional documentation have been approved by the UMC Utrecht Institutional Review Board. Main Author UMC Utrecht Work Package WP3 - Clinical validation studies Document PROMISE D3.3 Full institutional review board (IRB) approval (453.01 KB / 3_FULL-INSTITUTIONAL-REVIEW-BOARD-APPROVAL_V1) June 6, 2023 D3.2 Database development for patient recruitment, characterisation and sample allocation Description A user-friendly, GCP and GDPR compliant electronic data capture (EDC) system, Castor EDC, will be used to guarantee correct, complete and consistent data collection of the clinical studies of PROMISE Work Package (WP3). Electronic case report forms (eCRFs) will be developed and implemented on the EDC system. By using comprehensive data validation checks within these forms, only data of high quality will be submitted to the study database. The forms, integrated into the EDC system, will be easily accessible by a standard web browser. All study subjects will be identified with a participant identification code in order to safeguard the identity of the participants. The de-identified data will be stored on secure servers. Local teams will log patient identifiable data in a separate secure document to link the subject to the correct ID number noted on the eCRF. The system will meet all GCP and GDPR guidelines for electronic data collection in terms of protecting data integrity and securing the information collected. Main Author UMC Utrecht Work Package WP3 - Clinical validation studies Document PROMISE D3.2 Database development for patient recruitment, characterisation and sample allocation (224.07 KB / 2_DATABASE-DEVELOPMENT_V1) June 6, 2023 D2.3 Report on various effectiveness endpoints for clinical outcomes in RSV studies Description Using similar endpoints in clinical RSV studies (both clinical trials and observational studies) is crucial for the comparability of the efficacy or effectiveness of different products. Furthermore, the use of standardized endpoints helps determine the comparative cost-effectiveness of interventions in the society. We have reviewed endpoints used in previous clinical studies in the field of RSV and influenza and the strengths and limitations of each endpoint. This document is intended as a starting point for discussions between public health and private stakeholders and will feed into later PROMISE outputs, including study protocols. Future work (backed by a full systematic review of endpoints used in literature and stakeholder consultation) could classify endpoints further e.g., based on specificity and clinical relevance as well as pragmaticism and cost-efficiency of studying them. Main Author TUCH Work Package WP2 – Preparation for future RSV product assessment Document PROMISE D2.3 Report on various effectiveness endpoints for clinical outcomes in RSV studies (347.83 KB / 3_REPORT-ON-VARIOUS-EFFECTIVENESS-ENDPOINTS-FOR-CLINICAL-OUTCOMES-IN-RSV-STUDIES_V1) June 6, 2023 D2.2 Report on the impact of annual RSV awareness campaign November 2021 Description This is the first report of the annual RSV Awareness Week, organised by the RSV Patient Network. The RSV Awareness week is a special week at the beginning of November, in which the RSV Patient Network draws attention to and creates awareness about RSV around the expected start of the RSV season (in countries with a temperate climate in the Northern hemisphere). This report gives an overview of the activities of the RSV Awareness Week 2021 and their impact. It examines the effectiveness of the different activities on our social media channels. Results from previous years are compared with the results of the RSV Awareness Week 2021, to highlight our current strengths and identify areas for improvement for future campaigns, including RSV Awareness Weeks. This report will ultimately help us expand our global reach during future RSV Awareness Weeks. This report demonstrated that the international results of the Awareness Week of 2021 gained a greater total reach, engagements and page visitors compared to the Awareness Week of 2019 and 2020. We can conclude that AW’21 was a great success as we have increased awareness through the increase in followers, reach and engagements. Main Author RSV Patient Network/ReSViNET Work Package WP2 - Preparation for future RSV product assessment Document PROMISE D2.2 Report on the impact of annual RSV awareness campaign November 2021 (809.17 KB / 2_REPORT-ON-THE-IMPACT-OF-ANNUAL-RSV-AWARENESS-CAMPAIGN-NOVEMBER-2021_V1) June 6, 2023 D3.1 Design clinical protocol with WP4 partners to optimise patient recruitment and sampling for biomarker validation Description Human respiratory syncytial virus (RSV) causes severe disease in young infants. Besides young age, prematurity and congenital cardiopulmonary disease are known risk factors for severe disease. However, most children admitted to the hospital with RSV are previously healthy. To identify those at risk for severe disease, biomarkers are needed. In the RESCEU case-control study we established biomarkers predictive of, or associated with, lower respiratory tract RSV infection and disease severity. In this follow-up study the detected biomarkers will be validated. Main Author UMC Utrecht Work Package WP3 - Clinical validation studies Document PROMISE D3.1 Design clinical protocol with WP4 partners to optimise patient recruitment and sampling for biomarker validation (702.08 KB / 1_DESIGN-CLINICAL-PROTOCOL-WITH-WP4-PARTNERS_V1) March 15, 2023 This article was published on 2024-09-24
