RSV Observational Study 2

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Oxford
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01922648
First received: August 12, 2013
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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

Condition Intervention
Respiratory Syncytial Virus Infections
Procedure: Blood sample

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of the Immune Response to Respiratory Syncytial Virus (RSV) Exposure in a Paediatric Population

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • To assess the induction of RSV-specific immune responses in blood following natural exposure [ Time Frame: one year ] [ Designated as safety issue: No ]

    The following assays characterise the primary objective:

    • Anti-RSV antibody concentration and neutralisation capacity
    • T-cell immune responses


Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 35
Study Start Date: June 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
2-4 months
Infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV
Procedure: Blood sample
An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.
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
An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.
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
An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.

  Eligibility

Ages Eligible for Study:   2 Months to 6 Years
Genders Eligible for Study:   Both
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

Criteria

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:

  • 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
  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: NCT01922648

Contacts
Contact: Andrew J Pollard, PhD 01865857420 andrew.pollard@paediatrics.ox.ac.uk
Contact: Christopher A Green, MBBS 01865857420 christopher.green@paediatrics.ox.ac.uk

Locations
United Kingdom
Oxford University Hopsitals NHS Trust Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Christopher A Green, MBBS    01865857420    christopher.green@paediatrics.ox.ac.uk   
Principal Investigator: Andrew J Pollard, PhD         
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Andrew J Pollard University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01922648     History of Changes
Other Study ID Numbers: 2013/01
Study First Received: August 12, 2013
Last Updated: August 13, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
RSV
Immune response
Paediatric

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on August 27, 2014