Virus Interactions in the Respiratory Tract; a Cohort Study With Children

Study Overview
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Brief Summary
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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.

Official Title
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Virus Interactions in the Respiratory Tract; a Cohort Study With Children

Conditions
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Respiratory Tract Infections, Coinfection

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children<br>Children between 6 weeks and 4 years of age who have a older sibling or attend day care | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strength of viral interactions | To quantify the strength of interactions between common respiratory virus infections in young children. | Samples and data collected during 16 weeks of follow-up | 
| Direction of viral interactions | To quantify the direction of interactions between common respiratory virus | Samples and data collected during 16 weeks of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify relative change in disease severity due to viral interactions. | This will be measured as changes in disease severity scores of one virus infection upon recent exposure to another virus infection | Samples and data collected during 16 weeks of follow-up | 
| To estimate the seasonal incidence rates of both symptomatic and asymptomatic infection by common respiratory viruses in young children |  | Samples and data collected during 16 weeks of follow-up | 
| To estimate the probability of symptomatic versus asymptomatic infection per respiratory virus and host factors influencing this. |  | Samples and data collected during 16 weeks of follow-up | 
| 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 |  | Samples and data collected during 16 weeks of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Viral interference