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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06522880

Enrollment

Registered

2024-07-26

Start date

2023-08-10

Completion date

2027-12-31

Last updated

2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytomegalovirus Infections

Keywords

cytomegalovirus, CMV, congenital cytomegalovirus, cCMV

Brief summary

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.

Interventions

DIAGNOSTIC_TESTCMV PCR on saliva

Observational study to measure prevalence of CMV shedding by saliva PCR

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Days to 36 Months

Healthy volunteers

Inclusion criteria

Children 1. 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. 2. 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 1. Individuals who regularly (average \>/= 5 weeks per year) work inside the center in any role, including employed, contracted, volunteer, and full or part time. 2. 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 1. \>/= 37 months of age 2. State Department of Children and Families (DCF) custody Center Staff 1. Do not regularly (average \< 5 days per year) work inside the center 2. Work associated with but not regularly inside the center (e.g. bus drivers or food delivery staff)

Design outcomes

Primary

Measure	Time frame	Description
Prevalence of CMV shedding	Stage I up to 2 years	Prevalence of CMV shedding in children and childcare center staff. Shedding measured by CMV PCR on saliva.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLaura Gibson, MD

UMass Chan Medical School

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026