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

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.

Study Overview

• Status: Recruiting
• Conditions: Cytomegalovirus Infections
• Intervention / Treatment: Diagnostic test: CMV PCR on saliva

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Laura Gibson, MD; Phone Number: 5089813660; Email: laura.gibson@umassmed.edu
• Study Contact Backup: Name: Karen Del'Olio, MPH; Phone Number: 5084718701; Email: karen.del'olio@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • UMass Chan Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children; Children up to and including 36 months in large group childcare centers in the study network	Diagnostic test: CMV PCR on saliva; Observational study to measure prevalence of CMV shedding by saliva PCR
Staff; All staff members in large group childcare centers attended by children participants	Diagnostic test: CMV PCR on saliva; Observational study to measure prevalence of CMV shedding by saliva PCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: ModernaTX, Inc.
• Investigators: Principal Investigator: Laura Gibson, MD, UMass Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: cytomegalovirus; CMV; cCMV; congenital cytomegalovirus
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections
• Other Study ID Numbers: IRB 00000521

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No