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Completed

NCT Number: NCT05318235

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

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.

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Key information

Conditions

Respiratory Tract Infections Coinfection Infections Respiratory Tract Diseases

Age range

6 week–4 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Strength of viral interactions

    Time frame: Samples and data collected during 16 weeks of follow-up

    To quantify the strength of interactions between common respiratory virus infections in young children.

  2. Direction of viral interactions

    Time frame: Samples and data collected during 16 weeks of follow-up

    To quantify the direction of interactions between common respiratory virus

Secondary outcomes

  1. To quantify relative change in disease severity due to viral interactions.

    Time frame: Samples and data collected during 16 weeks of follow-up

    This will be measured as changes in disease severity scores of one virus infection upon recent exposure to another virus infection

  2. 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

  3. 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

  4. 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

Other outcomes

  1. 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

  2. To explore the nasal microbiological community in young children

    Time frame: Samples and data collected during 16 weeks of follow-up

  3. To examine immunity against respiratory viruses in saliva

    Time frame: Samples and data collected during 16 weeks of follow-up

  4. To explore viral-bacterial interactions in young children

    Time frame: Samples and data collected during 16 weeks of follow-up

  5. 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

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Acronym: VIOOL

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2022
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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