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

NCT06522880 | Recruiting

• 1 other identifier: IRB 00000521
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Infections

Keywords

cytomegalovirus; CMV; congenital cytomegalovirus; cCMV

Outcome Measures

Primary Outcomes (1)

• Prevalence of CMV shedding

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

  Stage I up to 2 years

Study Arms (2)

Children

Children up to and including 36 months in large group childcare centers in the study network

Diagnostic Test: CMV PCR on saliva

Staff

All staff members in large group childcare centers attended by children participants

Diagnostic Test: CMV PCR on saliva

Interventions

CMV PCR on saliva DIAGNOSTIC_TEST

Observational study to measure prevalence of CMV shedding by saliva PCR

Children; Staff

Eligibility Criteria

• Age: 1 Day - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited from all children and all staff at each center.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• ModernaTX, Inc.: collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Laura Gibson, MD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Gibson, MD

CONTACT

5089813660; laura.gibson@umassmed.edu

Karen Del'Olio, MPH

CONTACT

5084718701; karen.del'olio@umassmed.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 26, 2024
• Study Start: August 10, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

US (1)