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Recruiting

NCT Number: NCT06522880

Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study

The goal of STAGE I of the CMV TransmIT Study is to determine the prevalence of CMV shedding in children up to and including 36 months of age in large group childcare centers and in staff who regularly work at the center. Participants will complete a health survey and provide one saliva sample for CMV PCR testing. In addition, infrastructure for the study will be developed (e.g. community engagement to build the network of centers, data pipelines, digital platform, sampling workflows) and participant sample collection at home will be piloted. These activities will inform the design of STAGE II.

Recruiting

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Key information

Conditions

Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

1 day–36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Children

  • All children up to and including 36 months at time of signed consent regardless of duration of attendance at the center. Children living in the same household can each be enrolled.
  • Parent(s) has provided written informed consent for the child to be screened for CMV by saliva PCR collected at the center or at home

Center Staff

  • Individuals who regularly (average >/= 5 weeks per year) work inside the center in any role, including employed, contracted, volunteer, and full or part time.
  • Staff member has provided written informed consent to be screened for CMV by saliva PCR collected at the center or at home

Exclusion criteria

Children

  • >/= 37 months of age
  • State Department of Children and Families (DCF) custody

Center Staff

  • Do not regularly (average < 5 days per year) work inside the center
  • Work associated with but not regularly inside the center (e.g. bus drivers or food delivery staff)

Treatment and study plan

CMV PCR on saliva

Diagnostic Test

Observational study to measure prevalence of CMV shedding by saliva PCR

Primary outcomes

  1. Prevalence of CMV shedding

    Time frame: Stage I up to 2 years

    Prevalence of CMV shedding in children and childcare center staff. Shedding measured by CMV PCR on saliva.

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Del'Olio, MPH

CONTACT

karen.del'[email protected]

5084718701

Laura Gibson, MD

CONTACT

[email protected]

5089813660

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • ModernaTX, Inc.

Registry information

Official study title

Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study: An Observational Study to Evaluate CMV Transmission and Immune Correlates of Viral Shedding Among Young Children in Early Education and Care Settings

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 26, 2024
Registry last updated
Jul 26, 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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