€29m research grant to assess risk posed by deadly lung infections

Experts have received €29 million (£24m) to investigate serious lung infections that particularly affect babies and older people. Diseases caused by respiratory syncytial virus (RSV) are estimated to affect more than 30 million children under five each year throughout the world. The virus also affects older people and those with weakened immune systems, including cancer patients and people with chronic lung diseases such as emphysema.

There are no specific treatments for RSV and there is no vaccine. Current therapies are focused on alleviating the symptoms of the infection.

Led by Professor Harish Nair at the University of Edinburgh, the RSV Consortium in Europe (RESCEU) - aims to make a fundamental difference to the understanding and management of RSV.

International teams will work to assess the full scale of the problem in Europe, which is currently unknown.

Investigators from 18 universities, public health institutes and pharmaceutical companies will gather robust statistics on the number of RSV cases across Europe each year.

Researchers will also assess the economic impact of the disease and the burden it places on healthcare systems.

Armed with this information, the group will put together best practice guidelines to improve the way RSV-associated disease is monitored across Europe and to advise future vaccination programmes.

The consortium aims to ensure that future decisions on RSV prevention and treatment policies can be based on good evidence and made without undue delay.

The group also aims to set up a framework to conduct Europe-wide trials of new medicines and vaccines to improve treatment - and even prevention - of the disease.

They will collect and analyse patient samples to identify biological markers associated with severe RSV infections. Such markers could help to improve diagnosis and assessment of the severity of disease. They could also aid the development of treatments and vaccines.

Funding has been received from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement number 116019. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.

RESCEU was born out of an existing research collaboration called the Respiratory Syncytial Virus Network (ReSViNET) which aims to improve understanding of this virus, and to develop safe and effective preventive treatment and prevention strategies.

RSV infection causes breathing difficulties and wheezing and can lead to severe respiratory illnesses such as bronchiolitis or pneumonia.

The virus can be the most common single reason for children being admitted to hospital over the winter months. In older adults, the infections may cause as many severe illnesses, hospitalisations and deaths as influenza.

Project co-ordinator Professor Harish Nair, of the University of Edinburgh's Usher Institute, said: "We are at an opportune time to step up efforts to prevent RSV infection in children and elderly populations. With more than 65 candidate vaccines in clinical development, it is likely that an RSV vaccine will be available in the next five to seven years. Moreover, a range of treatments for RSV are also being developed. Our findings will provide better evidence to understand how these interventions should be best introduced, not only in Europe but also the rest of the world."

The collaboration includes the Universities of Edinburgh, Oxford and Imperial College London from the UK. Also taking part are teams from the University Medical Center Utrecht, University Medical Center Groningen and the National Institute for Public Health and The Environment in the Netherlands, the University of Antwerp in Belgium, the Galician Health Service SERGAS in Spain, the Hospital District of Southwest Finland, Statens Serum Institut in Denmark and the Paediatric European Network for Treatment of AIDS Foundation.

Six companies are participating in the project - AstraZeneca, Pfizer, GlaxoSmithKline Biologicals, Sanofi Pasteur, Janssen Pharmaceutica and Novavax - together with Synapse Research Management Partners.

A further 43 research and public health institutions, patient societies and clinical societies from Europe and rest of the world are also affiliated to the project.

RESCEU's vision 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 actively engage stakeholders in order 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 specific objectives of RESCEU are:
1. To conduct systematic reviews and assemble unpublished data to inform RSV epidemiology, disease burden (including sequelae) and resulting economic burden.
2. To develop a sustainable data platform to quantify health-care and economic impact of RSV (all ages and key risk groups) including sequelae at regional and national levels.
3. To report available RSV surveillance data from Europe; and in consultation with WHO/ECDC define best practice and standard operating procedures (SOPs) for R surveillance in Europe.
4. To estimate overall and risk group specific direct and indirect costs to health care systems, patients / child caregivers and society in the short, medium and long term to provide estimates of RSV attributable economic burden and potential cost-effectiveness of RSV vaccines.
5. To establish an effective Good Clinical Practice (GCP) study network for prospective studies including development of SOPs.
6. To conduct GCP multi-centre prospective studies to esta blish the incidence of RSV disease and document resource utili-sation by severity in healthy infants, high-risk infants, older adults (aged >60 years) and adults (aged ≥40 years) with COPD; and establish burden of longer-term disease sequelae.
7. To establish a biobank for identifying potential bio markers of RSV disease severity for further validation.
8. To establish an ethics/governance framework that will allow broad stakeholder engagement including with national and international public health agencies, the pharmaceutical industry and regulators.
9. To provide high-quality, sustainable, robust data collection systems that link closely with public health/regulatory bodies/health care providers for informing policy and regulatory processes.
10. To promote the dissemination of knowledge to a wide range of stakeholders, raise awareness, foster connectivity and promote informed action.