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Analysis of the Immune Response to Respiratory Syncytial Virus (RSV) Infection in Health Care Personnel
Sponsor study identifier
observational
30
1 country
1
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2012
Actual (reported)Study Completion
Not reported
Date not reportedRespiratory 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 5, 2011
Actual (reported)March 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 27, 2012
Actual (reported)August 2012
Actual (reported)Immune response to natural RSV exposure
To assess the induction of cellular responses and antibodies following natural exposure to RSV
July 2012 (up to 4 months)
NHS members of staff who regularly care for children admitted with RSV infections, and who therefore have a higher rate of exposure.
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.
Healthy health care personnel working in a pediatric ward and healthy volunteers from non-NHS staff
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, OX3 7LE, United Kingdom
Green CA, Sande CJ, de Lara C, Thompson AJ, Silva-Reyes L, Napolitano F, Pierantoni A, Capone S, Vitelli A, Klenerman P, Pollard AJ. Humoral and cellular immunity to RSV in infants, children and adults. Vaccine. 2018 Oct 1;36(41):6183-6190. doi: 10.1016/j.vaccine.2018.08.056. Epub 2018 Aug 31.
The humoral and cellular immune response to RSV exposure. To characterise these further some analysis of HLA typing my occur.
Andrew J Pollard, PhD
University of Oxford
30 participants (actual enrollment reported by the registry).
First Submitted
December 5, 2011
First Posted
March 27, 2012
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2012
Actual (reported)Last Updated
September 10, 2018
Record last verified: 2018-09
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Source: ClinicalTrials.gov.
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