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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RIA - Research and Innovation actionCoordinator
EH8 9YL Edinburgh
United Kingdom
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Participants (22)
3584 CX Utrecht
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2000 Antwerpen
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SW7 2AZ LONDON
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OX1 2JD Oxford
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00271 Helsinki
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3721 MA Bilthoven
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3500 BN Utrecht
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Participation ended
20520 Turku
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08007 Barcelona
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
3707 CD Zeist
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
2300 Kobenhavn S
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15703 Santiago De Compostela
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35127 Padova
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46010 Valencia
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6108 Halle
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69007 Lyon
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1330 Rixensart
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2340 Beerse
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20878 Gaithersburg
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CT13 9NJ Sandwich
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151 85 Sodertaelje
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20520 Turku
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