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Preparing for RSV Immunisation and Surveillance in Europe

Project description

Integrated efforts towards RSV immunisation

Respiratory syncytial virus (RSV) is highly contagious and affects the lungs and airways. RSV infection exhibits a seasonal pattern, and manifestation varies from typical flu-like symptoms to severe respiratory disease in young children and older adults. To avoid life-threatening RSV complications, there is an imminent need to introduce an RSV vaccine into national immunisation programmes. The EU-funded PROMISE project will undertake epidemiological analyses by collecting data from national registries and systematic reviews, and will validate new RSV infection biomarkers. The establishment of an EU-wide RSV surveillance system alongside the post-marketing monitoring and evaluation of the RSV vaccines in advanced clinical development will provide further evidence for the safety and efficacy of RSV immunisation.

Objective

RSV causes severe disease in the very young and elderly and results in substantial healthcare costs. In the last 4 years, substantial progress has been made in development of products for active and passive immunization against RSV, with 19 products currently in clinical development. In 2017, we were funded by IMI to set up RESCEU project (Grant Agreement number 116019), which is the single largest consortium currently working on RSV and has addressed several of the key evidence gaps to inform the introduction of an RSV vaccine. However, new gaps in evidence have emerged and many key requirements for the introduction of a novel RSV vaccine into national immunisation programmes (not addressed within RESCEU) remain unmet. PROMISE’s vision is to seamlessly build on, exploit, and add value to the significant achievements of RESCEU to prepare for the imminent introduction of an RSV vaccine. Expanding the existing RESCEU network to include 5 new partners, PROMISE comprises of 5 distinct but inter-connected work packages (WPs). WP 1 will conduct epidemiological and cost-effectiveness analyses marshalling data from systematic reviews; national and regional disease registries; surveillance programmes and linked routine healthcare datasets. WP2 will foster a consensus and develop an operational plan for expanded coordinated RSV surveillance and reporting activities; post-licensure monitoring and evaluation of products for RSV immunization across Europe. WP3 will initiate new prospective studies to address key gaps in existing knowledge (RSV disease severity scores, asthma in school age children) and assemble biobanks for biomarker validation. WP4 will validate temporally and at mucosal level biomarkers that were identified in RESCEU adopting state of the art technologies. WPs 1-4 will develop high-quality, sustainable, robust data collection systems that link closely with public health/regulatory bodies/health care providers for informing policy and regulatory processes.

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Topic(s)

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RIA - Research and Innovation action

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Call for proposal

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(opens in new window) H2020-JTI-IMI2-2020-22-single-stage

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Coordinator

THE UNIVERSITY OF EDINBURGH
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 746 625,00
Address
OLD COLLEGE, SOUTH BRIDGE
EH8 9YL Edinburgh
United Kingdom

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Region
Scotland Eastern Scotland Edinburgh
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 746 625,00

Participants (22)

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