Periodic Reporting for period 1 - PROMISE (Preparing for RSV Immunisation and Surveillance in Europe)
Reporting period: 2021-11-01 to 2023-01-31
Respiratory Syncytial Virus (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 immunisation against RSV, with 19 products currently in clinical development. This project builds on RESCEU’s (Respiratory Syncytial Virus Consortium in Europe) achievements, another IMI project focused on generating insights into the impact of RSV on healthcare systems and society (GA number 116019). New gaps in evidence have emerged and many key requirements for the introduction of a novel RSV vaccine into national immunisation programmes 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 RSV immunisation products (vaccines and monoclonal antibodies).
PROMISE comprises of 5 distinct but interconnected work packages (WPs). Workpackage (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 immunisation 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 as well as a serum biomarker of prior RSV experience in infants adopting state of the art technologies.
PROMISE 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.
PROMISE comprises of 5 distinct but interconnected work packages (WPs). Workpackage (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 immunisation 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 as well as a serum biomarker of prior RSV experience in infants adopting state of the art technologies.
PROMISE 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.
During the Reporting Period 1 (RP1), PROMISE has developed a modified RSV bronchiolitis severity score that has been validated externally in two small retrospective datasets; this requires further validation. After extensive consultation between public and private partners, we have developed a “Rules of Collaboration” document that provides a framework for engagement while discussing sensitive topics in the context of a public private partnership and has enabled public organisations outside the consortium to engage with PROMISE. For example, collaborative meetings have been organised with key stakeholders such as National Immunisation Technical Advisory Groups, WHO, ECDC, EMA. As part of WP2, a pilot surveillance bulletin has been developed and a report on effectiveness endpoints for clinical outcomes in RSV studies has been submitted to IHI. Additionally, the first survey to identify RSV immunisation barriers has been conducted targeting RSV vulnerable populations. WP3 obtained all ethical approvals and started recruitment to carry out clinical studies in order to establish the relationship between infant RSV infection and wheeze/asthma in school age children and the infant case-control biomarker validation study. WP4 carried out preparatory work for the identification of mucosal correlates for disease severity in paediatric RSV infection and planned for the validation of RSV severity biomarkers identified from peripheral blood in RESCEU. Additionally, all testing was performed for the confirmation of a biomarker of prior RSV experience in infants which could support further vaccine development in that population. In terms of communication and dissemination, PROMISE have conducted two RSV awareness week campaigns in November 2021 and 2022. During these weeks, the RSV Patient Network shared information regarding the impact of RSV on patients and health systems and stories on how RSV affected families of the patients. Furthermore, the consortium have been actively disseminating our analytic plans and interim results through posters and talks at major RSV-related conferences.
PROMISE is continuing to build on the achievements of its predecessor RESCEU and will provide sustainable long-term impact on RSV disease burden and thus make a significant contribution to improving health and wellbeing in Europe. PROMISE will form the platform for upcoming future actions on RSV and even other respiratory pathogens that are identified as a priority for action in Europe.
Although PROMISE has only completed 15 months, and it is too early to be able to measure impact at this stage, there are promising signs for the anticipated impact from this project. WP1 have developed a modified RSV bronchiolitis severity score that has been validated externally in two small retrospective datasets; this will now be validated prospectively in WP3 (Reporting Period 2, RP2). Once sufficiently validated, this could be used in clinical trials as well as observational studies to objectively document impact of RSV interventions (reduced RSV severity). We have had meaningful consultation with the Emergency Task Force at EMA towards the end of this Reporting Period (RP) and engagement with National Immunization Technical Advisory Groups (NITAGs) in the European region is planned for RP2. There has been ground-breaking progress in the field of RSV immunisation both for young infants and older adults during this RP. One long- acting monoclonal antibody for RSV has been licensed for use in young infants by EMA and MHRA. A maternal vaccine against RSV and three candidate vaccines against RSV targeting older adults have had successful phase 3 results and have either applied or are in the process of imminently applying for licensure in the EU and UK. PROMISE Consortium partners are providing the local/national and regional data (generated from RESCEU project) to the NITAGs and Regional Immunization Technical Advisory Groups (RITAGs) to inform the decision-making process for introduction of these novel immunisations. The action has already begun making an impact of its own. A pilot RSV bulletin has been developed and some feedback have been received (after circulating internally amongst both the public as well as EFPIA partners). A RSV bulletin will be launched from week 40 in 2023 (RP2). PROMISE Consortium members are continuing to support the WHO in their global RSV surveillance efforts and have been working with European and Global partners for harmonising and standardising the methodology for RSV genotyping. The consortium is now working towards development of a data visualisation dashboard to showcase PROMISE results and this should be available publicly in RP2. PROMISE have conducted RSV awareness week in November 2021 and 2022 to inform about the impact of RSV on patients and health systems. Partners have been actively disseminating our analytic plans and interim results through posters and talks at major RSV-related conferences. The PROMISE results from WP1 and WP3 will demonstrate the impact of COVID 19 on RSV epidemiology (disease burden and seasonality). Finally, we have been able to build on the RESCEU governance framework and agree on “Rules of Collaboration” document between public and private partners for sensitive topics in WP2 which has provided a framework and promoted confidence in the national public health institutes in EU (outwith our consortium) and ECDC to engage with PROMISE.
Although PROMISE has only completed 15 months, and it is too early to be able to measure impact at this stage, there are promising signs for the anticipated impact from this project. WP1 have developed a modified RSV bronchiolitis severity score that has been validated externally in two small retrospective datasets; this will now be validated prospectively in WP3 (Reporting Period 2, RP2). Once sufficiently validated, this could be used in clinical trials as well as observational studies to objectively document impact of RSV interventions (reduced RSV severity). We have had meaningful consultation with the Emergency Task Force at EMA towards the end of this Reporting Period (RP) and engagement with National Immunization Technical Advisory Groups (NITAGs) in the European region is planned for RP2. There has been ground-breaking progress in the field of RSV immunisation both for young infants and older adults during this RP. One long- acting monoclonal antibody for RSV has been licensed for use in young infants by EMA and MHRA. A maternal vaccine against RSV and three candidate vaccines against RSV targeting older adults have had successful phase 3 results and have either applied or are in the process of imminently applying for licensure in the EU and UK. PROMISE Consortium partners are providing the local/national and regional data (generated from RESCEU project) to the NITAGs and Regional Immunization Technical Advisory Groups (RITAGs) to inform the decision-making process for introduction of these novel immunisations. The action has already begun making an impact of its own. A pilot RSV bulletin has been developed and some feedback have been received (after circulating internally amongst both the public as well as EFPIA partners). A RSV bulletin will be launched from week 40 in 2023 (RP2). PROMISE Consortium members are continuing to support the WHO in their global RSV surveillance efforts and have been working with European and Global partners for harmonising and standardising the methodology for RSV genotyping. The consortium is now working towards development of a data visualisation dashboard to showcase PROMISE results and this should be available publicly in RP2. PROMISE have conducted RSV awareness week in November 2021 and 2022 to inform about the impact of RSV on patients and health systems. Partners have been actively disseminating our analytic plans and interim results through posters and talks at major RSV-related conferences. The PROMISE results from WP1 and WP3 will demonstrate the impact of COVID 19 on RSV epidemiology (disease burden and seasonality). Finally, we have been able to build on the RESCEU governance framework and agree on “Rules of Collaboration” document between public and private partners for sensitive topics in WP2 which has provided a framework and promoted confidence in the national public health institutes in EU (outwith our consortium) and ECDC to engage with PROMISE.