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REspiratory Syncytial virus Consortium in EUrope - Sofia ref.: 116019

Periodic Reporting for period 4 - RESCEU (REspiratory Syncytial virus Consortium in EUrope - Sofia ref.: 116019)

Periodo di rendicontazione: 2020-01-01 al 2020-12-31

Human Respiratory Syncytial Virus (RSV) is the most commonly identified pathogen in children with acute lower respiratory infections (ALRI) presenting as pneumonia or bronchiolitis. It causes severe disease in the very young, elderly and in high risk groups like those with congenital heart disease, congenital lung disease, immunosuppression etc. RESCEU’s aim is to integrate and exploit existing knowledge and data to provide greater insights into the impact of RSV on health systems and societies throughout Europe, and to engage stakeholders to improve strategic planning and decision-making. It also seeks to access existing clinically annotated biological specimens from prospective studies and to supplement this with bespoke clinical studies to create a powerful new bio-repository for future research. The collaboration within the Consortium has been productive during the first two years of the project and has progressed according to the plan.
Systematic literature review on RSV and current estimates of burden of disease (WP1)
During RP4, we completed 2 systematic reviews: the first on risk factors for RSV associated ALRI hospitalisation and mortality in young children; and the second on RSV comorbidities in adults including the elderly. We also finalised the individual patient data collection template and the list of variables under Task 1.9 on Global RSV disease burden estimates in preterm children. Under Task 1.10 we completed the update on the systematic literature search and included new data from 83 studies. During this RP, we have published 7 papers and have 2 papers currently under review.

Consolidation of health care systems data (WP2)
During RP4, this WP has been impacted by COVID-19. However, in Task 2.1 progress has been made in the 3 analysis strands. In strand 1 the main papers with results was published [Reeves 2020; Chung 2020]. The analysis related to risk groups has been completed and the manuscript is currently in preparation and expected for submission in early 2021. In strands 2 and 3 analysis plans were agreed and described in analysis plan documents. In Task 2.2 following the 1st RSV Surveillance meeting in 2019, a draft report of the workshop as a scientific manuscript co-authored by all meeting participants resulting in recommendations for alignment of national RSV surveillance systems was submitted to the European Respiratory Journal for publication in 2020. The manuscript is currently under revision after external review and will be re-submitted in January 2021. In addition, during 2020, we submitted and published 5 publications apart from the 2 manuscripts included above.

Retrospective resource use analyses from existing databases / networks (WP3)
During RP4, we have continued analysing cost and disease burden estimates from the literature, summarised in WP1, with the aim to use them in burden disease models. These estimates have been made for low and lower-middle income countries. Further estimates for the European high-income countries is expected to be submitted as a manuscript in 2021. Also, several models are being developed and are being tested as part this WP, mainly: static multi-country model “MC Marcel” by UA-LSHTM, static single cohort model for adult vaccination strategies by UMCG-Asc Academics-Novavax and two (dynamic) population models by SP and RIVM. An analysis using MC Marcel on Norway, a WP2 country that has been able to deliver data, is near completion. The UMCG-Asc Academics-Novavax model has been applied to the Netherlands and the UK (and has been submitted to Journal of Infectious Diseases).

Prospective data collection (WP4)

During RP4, for the birth cohort study, active follow up during the RSV season finished in April 2020 and results of RSV PCR of samples of all ARTI episodes will be available in the first quarter of 2021. Passive follow-up at the age of one year will be completed by July 2021. Manuscript submission about the main outcome (RSV incidence and hospitalization in healthy infants) is planned for the second half of 2021. The manuscript from the older adults cohort study reporting the main outcome (RSV incidence in older adults) has been published in European Respiratory Journal. For the COPD cohort study, recruitment and sample collection for the COPD cohort study has been completed. Results of RSV PCR in patients with COPD exacerbation using nasopharyngeal and sputum samples have been shared within the consortium.

Presumed risk factors and biomarkers for RSV-related severe disease and related sequelae (WP5)

During RP4, this WP was severely impacted by COVID-19. However, progress has been made in the following activities: Initial biomarker analysis, sample processing, management, selection and organisation of shipments between RESCEU partners. We have begun serum analysis for the COPD cohort samples. Five publications have been submitted during this period.
Project management and outreach to stakeholders (WP6)

During RP4, we reported our success to IMI and external evaluators at the Mid-Term Review and received excellent feedback and recommendations to make further improvements. Patient Advisory Board activities and Communication activities have experienced an increase; specifically, they were involved in the RSV Awareness Campaign promoted in November 2020. We started the preparation and organisation for GAM4 in Edinburgh, to take place on 17th and 18th June 2020. However, due to COVID-19 restrictions this was organised as a virtual event Monitoring the risk register also was a predominant activity as part of risk assessment due the COVID-19 pandemic. After the successful release of the RESCEU supplement in the Journal of Infectious Diseases in this RP4, we have commissioned a second supplement with the same journal to publish remainder of RESCEU manuscripts.
RESCEU will provide sustainable long-term impact on RSV disease burden and thus make a significant contribution to improved health and wellbeing in Europe. RESCEU will form the platform for upcoming future actions on RSV and even other pathogens which are identified as a priority for action in Europe.