PROMISE (Preparing for RSV Immunisation and Surveillance in Europe), an IMI (Innovative Medicines Initiative) project, kicks off today with the objective of taking a major leap forward in the fight against Respiratory Syncytial Virus (RSV) in Europe and worldwide. This initiative builds on the achievements of RESCEU (Respiratory Syncytial Virus Consortium in Europe), another IMI-funded project focused on generating insights into the impact of RSV on healthcare systems and society and creating a biorepository to assist future research.
Based on RESCEU’s results, PROMISE will aim to considerably advance scientific knowledge on RSV to better inform public health strategies and to support the development and monitoring of novel immunisation and therapeutics against this potentially deadly virus in the paediatric and elderly populations. At present, four potential vaccines and a monoclonal antibody to help protect against RSV are in Phase III clinical studies, whilst another 15 products are in other stages of clinical development.
Furthermore, the project will attempt to evaluate the impact of COVID-19 on RSV epidemiology with a special focus on older adults. Of particular note is the role of patient networks in this project. Besides providing valuable feedback on RSV research, they will assist with raising awareness about this disease and with seeking to foster confidence in vaccines by providing factual information and connecting scientists, industry, and society at large.
The PROMISE Consortium
Translational scientists, clinicians, public health agencies, the pharmaceutical industry, patient groups and clinical societies will work together within the PROMISE Consortium. The group represents 22 world class organisationswith an impressive track-record on RSV research. Harish Nair, Professor of Paediatric Infectious Diseases and Global Health at University of Edinburgh (UEDIN), Louis Bont, Professor of Paediatric Infectious Diseases and Immunology at University Medical Centre Utrecht (UMCU), and Charlotte Vernhes, Translational Lead Scientist at Sanofi Pasteur, will lead the initiative. PROMISE is being funded with 7 million euros by IMI and will end in April 2024. IMI is the world’s biggest public-private partnership in life sciences and is supported by the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Focus on long-term impact
RSV is associated with substantial disease burden in young children and the elderly. Globally, an estimated 33 million young children are diagnosed with RSV disease each year, with over 3 million cases requiring hospitalisation. RSV disease accounts for hospitalisation of 1 in 5 young children <5 years diagnosed with acute lower respiratory infections (ALRI) and 1 in 6 in adults > 65 years. Annually, RSV causes an estimated 118,000 child deaths worldwide. RSV costs governments around the world nearly 5 billion euros every year. PROMISE aims to decrease this burden by:
• enhancing the value proposition for RSV immunisation by generating new insights on RSV and addressing current gaps, such as understanding the relationship between RSV infection and school age wheeze and asthma;
• identifying new diagnostic tools and prophylactic interventions; and
• adding knowledge on RSV biomarkers.
The project members will work to develop a robust surveillance network on RSV disease, with the goal of strengthening epidemiological and virological surveillance in Europe, sharing this data among public health institutes, and disclosing surveillance data to the community. This will contribute to widening knowledge on respiratory infections in the community and guiding therapeutic developments in the long term. Special attention will be paid to specific populations such as pregnant women and older adults.
The significance of PROMISE explained by its leaders
Harish Nair (UEDIN), project scientific co-coordinator: “We hope PROMISE will generate new data and resources that will improve our understanding of RSV, particularly how this has changed in the context of the ongoing COVID-19 pandemic. We are now within sight of multiple products to immunise against RSV in different population groups and this project aims to lay the groundwork to facilitate the early introduction and uptake of these products in Europe.”
Louis Bont (UMCU), project scientific co-coordinator: “In PROMISE, we will generate data that will potentially usher in a new period of RSV treatment for Paediatrics, Obstetrics, and Internal Medicine. Combining scientific data with patient involvement will help guide the introduction of novel therapeutics and vaccines for RSV, one of the most important respiratory diseases.”
Charlotte Vernhes (SP), project leader: “Building on the strong collaborations established in RESCEU, PROMISE will further expand our knowledge of RSV and pave the way for the successful rollout of novel RSV immunization strategies addressing a high global unmet need. This new consortium continues to place patients at the centre and brings international experts together to establish sustainable solutions and support decision making.”