Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-26 @ 7:11 PM
Study NCT ID:
NCT01563692
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2011-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response to Respiratory Syncytial Virus (RSV) in Health Care Workers
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
Analysis of the Immune Response to Respiratory Syncytial Virus (RSV) Infection in Health Care Personnel
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Respiratory Syncytial Virus (RSV) is a human restricted pathogen and is the single most important cause of severe respiratory illness in infants and young children, a major cause of infantile bronchiolitis and is the most frequent cause of hospitalization of infants and young children in industrialized countries. Severe RSV infection early in life is associated with an increased risk of subsequent recurrent wheezing and asthma. There are few population-based estimates of the incidence of RSV disease from developing countries, but the existing data clearly indicates that the virus accounts for a high proportion of Acute Respiratory Infections (ARI) in children. Studies in Brazil, Colombia and Thailand suggest that RSV causes 20-30% of ARI cases in children from 1-4 years of age, a proportion similar to that in industrialized countries, and WHO has estimated the global RSV disease burden at 64 million cases and 160 000 deaths every year. RSV also causes severe disease in elderly and immune-compromised adults, and the burden of RSV disease in the elderly is comparable to that of seasonal influenza. The economic impact of RSV-related disease in adults estimated to be greater than that of influenza in relation to numbers of days lost from work.
The development of a safe and effective vaccine against RSV would benefit greatly from data on the immune responses in healthy adults naturally exposed to the virus. RSV infection has been shown to increase and induce short-lived circulating antibody secreting cells and produce an increase in the RSV specific antibody titres but very limited data is available on the cellular immune responses induced by RSV during natural infection in healthy adults. The existence of cell mediated immune response against RSV in humans has been described but characterization of this response remains poor and simultaneous analysis of several immunological parameters have not been attempted in an RSV exposed population before.
The development of a safe and effective vaccine against RSV would benefit greatly from data on the immune responses in healthy adults naturally exposed to the virus. RSV infection has been shown to increase and induce short-lived circulating antibody secreting cells and produce an increase in the RSV specific antibody titres but very limited data is available on the cellular immune responses induced by RSV during natural infection in healthy adults. The existence of cell mediated immune response against RSV in humans has been described but characterization of this response remains poor and simultaneous analysis of several immunological parameters have not been attempted in an RSV exposed population before.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: