- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01922648
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Oxford, Regno Unito, OX3 9DU
- Oxford University Hopsitals NHS Trust
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
To assess the induction of RSV-specific immune responses in blood following natural exposure
Lasso di tempo: one year
|
The following assays characterise the primary objective:
|
one year
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Andrew J Pollard, University of Oxford
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2013/01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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