Virus Interactions in the Respiratory Tract; a Cohort Study With Children (VIOOL)
Rationale: Prevention of virus induced acute respiratory infection (ARI) is a public health priority. As different respiratory virus infections can interact with each other, occurrence of one virus may influence occurrence of other virus infections. Such interactions can have implications for the effects of vaccination on non-target diseases. In this project, we will quantify such interactions between respiratory viruses by longitudinally studying a cohort of young children.
Objective: To quantify the strength and direction of interactions between important respiratory virus infections in young children.
Study design: This is a prospective observational cohort study.
Study population: Children between 6 weeks and 4 years of age residing in the Utrecht area of the Netherlands.
Main study parameters/endpoints: Frequency, timing and sequences of occurrence of respiratory virus infections will be studied for each participant using weekly collected nasal specimens during 16 weeks follow-up. Detection will be based on PCR testing for a panel of common respiratory viruses. From these data, estimation of virus interaction parameters will be based on self-controlled-case series analysis.
Nature and extend of the burden and risks associated with participation, benefit and group relatedness: This study is observational in nature. There will be no direct benefit to research participants. The study includes biological sampling. The results of the tests done on these samples may not contribute to improving the participant's health. Minimal inconvenience and discomfort to the participant may arise from study visits and biological sampling.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Utrecht, Netherlands, 3584 CX
- UMC Utrecht
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 6 weeks and 4 years AND
- 1) have older siblings or 2) attend daycare. AND
- Live within 30 minutes drive from UMCU (by car), have access to a fever thermometer and a freezer were biological samples can be temporarily stored
Exclusion Criteria:
- recurrent respiratory tract infections and are treated with antibiotic prophylaxis OR
- known immunodeficiency OR
- chronic lung disease that increases susceptibility to infection (e.g. cystic fibrosis) OR
- congenital anomalies of the airways
- Parents/guardians have insufficient comprehension of Dutch language (all study communication and questionnaires are in Dutch language)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Children
Children between 6 weeks and 4 years of age who have a older sibling or attend day care
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No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Strength of viral interactions
Time Frame: Samples and data collected during 16 weeks of follow-up
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To quantify the strength of interactions between common respiratory virus infections in young children.
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Samples and data collected during 16 weeks of follow-up
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Direction of viral interactions
Time Frame: Samples and data collected during 16 weeks of follow-up
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To quantify the direction of interactions between common respiratory virus
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Samples and data collected during 16 weeks of follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To quantify relative change in disease severity due to viral interactions.
Time Frame: Samples and data collected during 16 weeks of follow-up
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This will be measured as changes in disease severity scores of one virus infection upon recent exposure to another virus infection
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Samples and data collected during 16 weeks of follow-up
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To estimate the seasonal incidence rates of both symptomatic and asymptomatic infection by common respiratory viruses in young children
Time Frame: Samples and data collected during 16 weeks of follow-up
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Samples and data collected during 16 weeks of follow-up
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To estimate the probability of symptomatic versus asymptomatic infection per respiratory virus and host factors influencing this.
Time Frame: Samples and data collected during 16 weeks of follow-up
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Samples and data collected during 16 weeks of follow-up
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|
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To quantify the changes in viral exposure in the pandemic-to-post-pandemic transition period and study effects of these changes on viral interaction patterns
Time Frame: Samples and data collected during 16 weeks of follow-up
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Samples and data collected during 16 weeks of follow-up
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To explore local inflammatory responses that could mediate observed virus interaction patterns and effects on disease severity
Time Frame: Samples and data collected during 16 weeks of follow-up
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Samples and data collected during 16 weeks of follow-up
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To explore the nasal microbiological community in young children
Time Frame: Samples and data collected during 16 weeks of follow-up
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Samples and data collected during 16 weeks of follow-up
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To examine immunity against respiratory viruses in saliva
Time Frame: Samples and data collected during 16 weeks of follow-up
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Samples and data collected during 16 weeks of follow-up
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To explore viral-bacterial interactions in young children
Time Frame: Samples and data collected during 16 weeks of follow-up
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Samples and data collected during 16 weeks of follow-up
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To study the effect of pandemic exposure on respiratory infections and local inflammatory responses
Time Frame: Samples and data collected during 16 weeks of follow-up
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Samples and data collected during 16 weeks of follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patricia Bruijning, MD PhD, UMC Utrecht
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL78424.041.21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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