RSV Observational Study 2
Analysis of the Immune Response to Respiratory Syncytial Virus (RSV) Exposure in a Paediatric Population
Respiratory Syncytial Virus (RSV) is a virus that causes chest infections. It is the single most important cause of severe respiratory illness in infants and young children, and severe RSV infection early in life is associated with an increased risk of later developing asthma. RSV also causes severe disease in elderly and immune-compromised adults, and the amount of RSV disease in the elderly is similar to that from seasonal flu. The virus is transmitted in the secretions of the upper respiratory tract of infected individuals and by contact with contaminated surfaces (such as toys). Hospital outbreaks, especially on paediatric and neonatal wards, are not uncommon.
Infection by RSV does not develop a natural long-lasting protection against re-infection (like, for example, measles does). In the USA nearly all children by 24 months of age have been infected at least once with RSV, and about half will have experienced two infections. There is no effective anti-viral drug to treat an infection and the only way of managing cases of severe infection is through supporting organs, such as the lungs, to withstand and recover from the illness.
There remains a real need to develop an effective vaccine to prevent severe infections caused by RSV. A better understanding of the way the immune system responds to RSV in children would aid the development of such a vaccine.
The purpose of this study is to increase our understanding of how the immune system responds to RSV. Only limited data is available on some important components of the immune response and this study is designed to measure these in more detail. This is done using a single blood sample.
A total of 35 children are anticipated to be recruited to this study, at ages when we expect to see differences in the immune response to RSV;
- 5 infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV
- 20 infants aged between 6 and 12 months (Group 2), who will have had exposure to one single RSV season in the winter of 2011/12
- 10 children aged between 3 and 6 years (Group 3), who have been exposed to RSV over several winter seasons
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Oxford, Storbritannien, OX3 9DU
- Oxford University Hopsitals NHS Trust
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Parent or guardian is willing and able to give informed consent for participation in the study
- Age suitable for Group 1, 2 or 3 as defined in above (Section 6.2)
- Delivery at 36 weeks gestation or later
- Having a blood sample for clinical reasons
Exclusion Criteria:
- Parent or guardian unable or unwilling to give informed consent for participation in the study
- Any impaired function of the immune system, by medication or pathological process, which could augment or impair the immune response to RSV
- Concurrent acute or chronic infection
- Any chronic illness which, in the opinion of the Investigator, may lead to incorrect or inaccurate immunology data
- History of immunoprophylaxis with Palivizumab
- Delivery prior to 36 weeks gestation
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
2-4 months
Infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV
|
An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.
|
|
6 - 12 months
Infants aged between 6 and 12 months (Group 2), who will have had exposure to one single RSV season in the winter of 2011/12
|
An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.
|
|
3 - 6 years
Children aged between 3 and 6 years (Group 3), who have been exposed to RSV over several winter seasons
|
An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
To assess the induction of RSV-specific immune responses in blood following natural exposure
Tidsram: one year
|
The following assays characterise the primary objective:
|
one year
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Andrew J Pollard, University of Oxford
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2013/01
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