Cytomegalovirus InfectionsNCT06522880
Cytomegalovirus (CMV) Transmission and Immune Tracking (TransmIT) Study
An observational study of Cytomegalovirus Infections, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 36 months
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- CMV PCR on saliva
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: Study participants will be recruited from all children and all staff at each center.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official 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
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
- Being tested
- CMV PCR on saliva
- Keywords
- cytomegalovirus, CMV, congenital cytomegalovirus, cCMV
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMV PCR on salivaDiagnostic test
Observational study to measure prevalence of CMV shedding by saliva PCR
| Study group | Role | What they receive |
|---|---|---|
| Children | Children up to and including 36 months in large group childcare centers in the study network Receives: Diagnostic Test: CMV PCR on saliva | |
| Staff | All staff members in large group childcare centers attended by children participants Receives: Diagnostic Test: CMV PCR on saliva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of CMV shedding
Prevalence of CMV shedding in children and childcare center staff. Shedding measured by CMV PCR on saliva.
Measured: Stage I up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start10 Aug 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Due to a lack of funding this study was unable to enroll participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- ModernaTX, Inc.
- Responsible party
- Sponsor
- Investigators
- Laura Gibson, MD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522880
- Sponsor's protocol ID
- mRNA-1647-P901
- Other IDs
- IRB 00000521
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06522880
- Acronym / sponsor ID
- mRNA-1647-P901
- Conditions
- Cytomegalovirus Infections
- Keywords
- cytomegalovirus, CMV, congenital cytomegalovirus, cCMV
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to a lack of funding this study was unable to enroll participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- ModernaTX, Inc.
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | Diagnostic Test: CMV PCR on salivaChildren up to and including 36 months in large group childcare centers in the study network |
| Staff | – | Diagnostic Test: CMV PCR on salivaAll staff members in large group childcare centers attended by children participants |
Who may qualify
- Ages
- 1 day to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study participants will be recruited from all children and all staff at each center.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMV PCR on salivaObservational study to measure prevalence of CMV shedding by saliva PCR | Diagnostic test | Children, Staff |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Gibson, MD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of CMV shedding (time frame: Stage I up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.