Estimating the burden of disease caused by RSV in older adults

• Research type

  Research Study

• Full title

  A prospective, multi-country, multicentre cohort study to assess the disease burden of RSV associated ARI in community dwelling (CD) and long-term care facilities (LTCF) adults ≥ 50 years of age during two consecutive RSV seasons in the US and Europe.

• IRAS ID

  228276

• Contact name

  Sheena R Gomez

• Contact email

  sheena.r.gomez@gsk.com

• Sponsor organisation

  GSK Vaccines

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  Summary of Research

  Respiratory Syncytial Virus (RSV) is a virus that can cause respiratory illnesses. Severe RSV illness can result in pneumonia (lung infection) and cause respiratory failure or death. So far, there is no effective treatment or vaccine available against RSV in adults.

  Older adults have a higher risk of getting a severe RSV illness. This is due to weakening of the immune response and presence of additional diseases leading to an increased risk of serious illness. It is well known that RSV can cause severe respiratory illness in infants, but little is known about the severity of RSV respiratory illness in older adults living in the community or in long-term care facilities LTCF (e.g. care homes, residential homes, assisted living facilities). In the United States (US), about 207 000 people over age 65 will need to go to the hospital each year because of RSV illness and about 16 000 die each year because of RSV illness. In Europe (including UK), information on burden of disease due to RSV is limited.

  This GlaxoSmithKline funded prospective multi-centre study is being conducted in hospitals/GP practices/care homes from Europe and USA. The purpose of the study is to learn more about the burden of disease caused by RSV in people aged 50 years and older and support in the development of GSK Biologicals’ candidate RSV vaccine in the future.
  About 2000 adults aged 50 years and above will be invited to take part in this research study. 1250 adults (100 in UK) from the community and 667 adults (70 in UK) aged 65+ years living in LTCF will be invited. Participants will attend at least 2 scheduled visits and be followed by researchers for 2 years. During the study participants will undergo a range of clinical assessments and fitness tests. Participants will be regularly contacted during the RSV season for monitoring respiratory illness. Blood samples, throat/nasal swabs will be taken to check for RSV.

  Summary of Results

  As this is an observational study it is not in scope for a lay summary, though the scientific result summary can be found here:
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbajg-2BbaVd1s2myPYgkuiRqs87CS-2BBWrfKeTebJK2Orkz59ithJJkKfRgTMij2mpI-2Bv8MPIz2eSyv4BTWPuRXH4o-3DAz3X_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLAXQxtFVX0KvfexWFh0EGmtAYYDuUUGRLXt6DKbgHg4n-2Be9kG7iZvuyftyL2F95Oc7zBi4mz2flDEM-2BjUGeLUZRLrisY9u7JwjlHVeYRX9sQEbZr2-2FZjASQptrCCFEszZ-2BKLvQXqJGG9Nlt4B0w41tnee0MfAVh652DbhB0cGHZ6uVT1w2-2F668kXIkCAbSk8M-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ce30ae1371d9646d4fade08db44c6c0bd%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638179392656666292%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=oYGpbWSkLQ4foaYiyFmm93WU0PiUyraIu4vF2mnApDE%3D&reserved=0

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  19/LO/0679

• Date of REC Opinion

  5 Jun 2019

• REC opinion

  Further Information Favourable Opinion