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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Okairos
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
  Purpose

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.


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of the Immune Response to Respiratory Syncytial Virus (RSV) Infection in Health Care Personnel

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

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


Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563692

Locations
United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
University of Oxford
Okairos
Investigators
Principal Investigator: Andrew J Pollard, PhD University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01563692     History of Changes
Other Study ID Numbers: 2011/08
Study First Received: December 5, 2011
Last Updated: August 12, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
RSV
Immune response

ClinicalTrials.gov processed this record on July 28, 2014