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Immune Response to Respiratory Syncytial Virus (RSV) in Health Care Workers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
ReiThera Srl
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01563692
First received: December 5, 2011
Last updated: August 12, 2013
Last verified: August 2013

December 5, 2011
August 12, 2013
March 2012
October 2013   (final data collection date for primary outcome measure)
Immune response to natural RSV exposure [ Time Frame: July 2012 (up to 4 months) ] [ Designated as safety issue: No ]
To assess the induction of cellular responses and antibodies following natural exposure to RSV
Same as current
Complete list of historical versions of study NCT01563692 on ClinicalTrials.gov Archive Site
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Immune Response to Respiratory Syncytial Virus (RSV) in Health Care Workers
Analysis of the Immune Response to Respiratory Syncytial Virus (RSV) Infection in Health Care Personnel

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

The humoral and cellular immune response to RSV exposure. To characterise these further some analysis of HLA typing my occur.

Non-Probability Sample

Healthy health care personnel working in a pediatric ward and healthy volunteers from non-NHS staff

Healthy
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  • Paediatric health care workers
    NHS members of staff who regularly care for children admitted with RSV infections, and who therefore have a higher rate of exposure.
  • Non-paediatric health care workers
    This is a comparator group made up of healthy adults who do not work in an occupation or have other risk factors for higher exposure to RSV.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing and able to give informed consent for participation in the study and comply with study requirements
  • Male or Female, aged from 18 to 60 in healthy status.
  • Working on a paediatric ward which admits acute medical paediatric admissions during the RSV season (Group 1 only).

Exclusion Criteria:

  • History of any immunodeficiency or immunological disorder which could affect the acquisition of RSV responses.
  • Use of immunosuppressive medications such as steroids.
  • Working on an NHS ward or in close contact with populations at higher risk of RSV transmission (e.g. nursery workers, care home workers, parents of young children) during the RSV season (Group 2 only).
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01563692
2011/08
No
University of Oxford
University of Oxford
ReiThera Srl
Principal Investigator: Andrew J Pollard, PhD University of Oxford
University of Oxford
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP