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

NCT ID: NCT01563692

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31

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.

Conditions

Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ReiThera Srl

INDUSTRY

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew J Pollard, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Centre for Clinical Vaccinology and Tropical Medicine

Oxford, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 30177258 (View on PubMed)

Other Identifiers

2011/08

Identifier Type: -

Identifier Source: org_study_id