Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study
ConditionCytomegalovirus Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-36
SponsorUniversity of Massachusetts, Worcester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
>/= 37 months of age
State Department of Children and Families (DCF) custody
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)
Trial population
Study participants will be recruited from all children and all staff at each center.
Trial design
Design model
Ecologic or community
Time perspective
Cross-sectional
Treatments tested in this trial
CMV PCR on saliva
Diagnostic testObservational study to measure prevalence of CMV shedding by saliva PCR
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Children1 intervention
Group B: Staff1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of CMV shedding
Prevalence of CMV shedding in children and childcare center staff. Shedding measured by CMV PCR on saliva.
Time frame
Stage I up to 2 yearsSponsors and contacts
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University of Massachusetts, Worcester
Lead sponsor
ModernaTX, Inc.
Collaborator
Source ClinicalTrials.gov