Respiratory Syncytial Virus InfectionsNCT01922648
RSV Observational Study 2
An observational study of Respiratory Syncytial Virus Infections, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- Blood sample
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants aged 2-4 months inclusive Infants aged 6-12 months inclusive Children aged 3-6 years inclusive
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hopsitals NHS Trust
Oxford, OX3 9DU
About this study
Official title: 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.
Read more
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
- Being tested
- Blood sample
- Keywords
- RSV, Immune response, Paediatric
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.
| Study group | Role | What they receive |
|---|---|---|
| 2-4 months | Infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV Receives: 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 Receives: 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 Receives: Procedure: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew J Pollard, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922648
- Sponsor's protocol ID
- 2013/01
- Status last verified
- Sep 2018
- First submitted
- 12 Aug 2013
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Immune Response to Respiratory Syncytial Virus (RSV) Exposure in a Paediatric Population
- ClinicalTrials.gov ID
- NCT01922648
- Acronym / sponsor ID
- 2013/01
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- RSV, Immune response, Paediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2015 (actual)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2-4 months | – | Procedure: Blood sampleInfants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV |
| 6 - 12 months | – | Procedure: Blood sampleInfants aged between 6 and 12 months (Group 2), who will have had exposure to one single RSV season in the winter of 2011/12 |
| 3 - 6 years | – | Procedure: Blood sampleChildren aged between 3 and 6 years (Group 3), who have been exposed to RSV over several winter seasons |
Who may qualify
- Ages
- 2 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants aged 2-4 months inclusive Infants aged 6-12 months inclusive Children aged 3-6 years inclusive
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleAn extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason. | Procedure or surgery | 2-4 months, 3 - 6 years, 6 - 12 months |
Primary outcome
To assess the induction of RSV-specific immune responses in blood following natural exposure
Time frame: one year
The following assays characterise the primary objective: * Anti-RSV antibody concentration and neutralisation capacity * T-cell immune responses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Pollard principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus Infections, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the induction of RSV-specific immune responses in blood following natural exposure (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.