RSV Observational Study 2

Analysis of the Immune Response to Respiratory Syncytial Virus (RSV) Exposure in a Paediatric Population

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

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Procedure: Blood sample

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one year

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Andrew J Pollard, University of Oxford

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: August 12, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (Estimate): August 14, 2013

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: RSV; Immune response; Paediatric
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: 2013/01