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RSV Observational Study 2

NCT01922648 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2018-09-10

No results posted yet for this study

Summary

Respiratory Syncytial Virus (RSV) is a virus that causes chest infections. It is the single most important cause of severe respiratory illness in infants and young children, and severe RSV infection early in life is associated with an increased risk of later developing asthma. RSV also causes severe disease in elderly and immune-compromised adults, and the amount of RSV disease in the elderly is similar to that from seasonal flu. The virus is transmitted in the secretions of the upper respiratory tract of infected individuals and by contact with contaminated surfaces (such as toys). Hospital outbreaks, especially on paediatric and neonatal wards, are not uncommon.

Infection by RSV does not develop a natural long-lasting protection against re-infection (like, for example, measles does). In the USA nearly all children by 24 months of age have been infected at least once with RSV, and about half will have experienced two infections. There is no effective anti-viral drug to treat an infection and the only way of managing cases of severe infection is through supporting organs, such as the lungs, to withstand and recover from the illness.

There remains a real need to develop an effective vaccine to prevent severe infections caused by RSV. A better understanding of the way the immune system responds to RSV in children would aid the development of such a vaccine.

The purpose of this study is to increase our understanding of how the immune system responds to RSV. Only limited data is available on some important components of the immune response and this study is designed to measure these in more detail. This is done using a single blood sample.

A total of 35 children are anticipated to be recruited to this study, at ages when we expect to see differences in the immune response to RSV;

* 5 infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV
* 20 infants aged between 6 and 12 months (Group 2), who will have had exposure to one single RSV season in the winter of 2011/12
* 10 children aged between 3 and 6 years (Group 3), who have been exposed to RSV over several winter seasons

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

PROCEDURE

Blood sample

An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Andrew J Pollard · University of Oxford

Eligibility

Min Age
2 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01922648 on ClinicalTrials.gov