RSV001 - A new vaccine to prevent severe viral chest infections.

• Research type

  Research Study

• Full title

  A phase I study to assess safety and immunogenicity of a new Respiratory Syncytial Virus (RSV) vaccine based on the RSV viral proteins F, N and M2-1 encoded by simian Adenoviruses (ChAd63-RSV and PanAd3-RSV) and by the Modified Vaccinia virus Ankara (MVA-RSV)

• IRAS ID

  120041

• Contact name

  Andrew J Pollard

• Sponsor organisation

  ReiThera Srl

• Eudract number

  2011-003589-34

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Respiratory Syncytial Virus, or RSV, causes respiratory infections such as bronchiolitis and pneumonia. It can affect all ages, but especially severe in infants, adults with an impaired immune system, and the elderly. RSV only infects humans and occurs in epidemics every winter. It is the single most common cause of severe respiratory illness in children and accounts for approximately 30% of all acute admissions to children's wards in the UK. The most vulnerable are those under one year of age, babies born with heart or lung problems, and babies born prematurely. The amount of RSV disease in the elderly is similar to flu and the economic impact of RSV-related disease in adults (measured by the number of days off work) is estimated to be greater than flu Infection with RSV is very common. 80% of children will have been infected by their first birthday and approximately 1% of these infants will need treatment in hospital. Unlike measles, for example, infection with RSV does not lead to protective immunity and 50% of infants will have been re-infected by their second birthday. Re-infection can occur throughout life and healthy adults often experience this as a self-limiting flulike illness but are infectious to their close contacts. There is no effective anti-viral medication to treat RSV infections and no licensed vaccine. The most severe cases need artificial ventilation in Intensive Care Units and almost all infant deaths from RSV are in the Developing World where such expensive care doesn't exist. The RSV vaccines used in this study (called Chad63-RSV, PanAd3-RSV and MVA-RSV) use a 'vector' (a harmless carrier virus) to deliver RSV proteins. This approach has worked well in vaccine trials against other diseases, and we hope this may trigger immune responses (RSV targeting antibody and cells) that may protect against developing severe RSV disease.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  13/SC/0023

• Date of REC Opinion

  5 Mar 2013

• REC opinion

  Favourable Opinion