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CompletedNCT01922648Updated Sep 10, 2018

RSV Observational Study 2

An observational study in Respiratory Syncytial Virus Infections, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 2 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-10.

Sponsored by University of Oxford · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
35
Ages
2 Months to 6 Years
Sex
All
01

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
02

Conditions studied

  • Respiratory Syncytial Virus Infections

Keywords

  • RSV
  • Immune response
  • Paediatric
03

In context

Respiratory Syncytial Virus Infections

293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.

This study's enrollment of 35 is below the median of 346 across 73 observational studies indexed under Respiratory Syncytial Virus Infections.

Browse Respiratory Syncytial Virus Infections studies →

Lead sponsor

University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Infants aged 2-4 months inclusive Infants aged 6-12 months inclusive Children aged 3-6 years inclusive

Inclusion criteria

  • Parent or guardian is willing and able to give informed consent for participation in the study
  • Age suitable for Group 1, 2 or 3 as defined in above (Section 6.2)
  • Delivery at 36 weeks gestation or later
  • Having a blood sample for clinical reasons

Exclusion criteria

Exclusion Criteria:

  • Parent or guardian unable or unwilling to give informed consent for participation in the study
  • Any impaired function of the immune system, by medication or pathological process, which could augment or impair the immune response to RSV
  • Concurrent acute or chronic infection
  • Any chronic illness which, in the opinion of the Investigator, may lead to incorrect or inaccurate immunology data
  • History of immunoprophylaxis with Palivizumab
  • Delivery prior to 36 weeks gestation
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
35 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 2-4 months

    Infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV

    Procedure: Blood sample

  • 6 - 12 months

    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

    Procedure: Blood sample

  • 3 - 6 years

    Children aged between 3 and 6 years (Group 3), who have been exposed to RSV over several winter seasons

    Procedure: Blood sample

Interventions

  • ProcedureBlood sample

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

06

What researchers measure

Primary outcomes

  1. To assess the induction of RSV-specific immune responses in blood following natural exposure

    The following assays characterise the primary objective: * Anti-RSV antibody concentration and neutralisation capacity * T-cell immune responses

    Time frame: one year

07

Study locations

1 site
  • Oxford University Hopsitals NHS Trust
    Oxford, OX3 9DU, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01922648
Lead sponsor
University of Oxford
Responsible party
Sponsor
First posted
Aug 14, 2013
Start date
Jun 2013
Primary completion
Apr 2015
Last update
Sep 10, 2018

Study contacts

Andrew J Pollard
principal investigator · University of Oxford

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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