Saliva Testing for Cytomegalovirus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on how often young children and childcare staff spread cytomegalovirus (CMV), a common virus that may not cause symptoms in healthy children but can be serious for others. Participants will complete a health survey and provide a saliva sample for CMV testing. The trial aims to develop better systems for collecting data and samples, which will inform the design of the next study phase. Children up to 36 months old attending large group childcare centers and staff working there regularly are ideal candidates for this study. As an unphased trial, it offers participants the chance to contribute to foundational research that could enhance public health strategies.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems unlikely since the study involves only a saliva test for CMV.
What prior data suggests that this saliva testing method is safe for children and staff?
Research has shown that using saliva samples for CMV testing is generally safe. Studies have found that CMV testing in saliva effectively detects the virus.
No reports of serious safety issues exist with this type of testing. However, the test might occasionally indicate the presence of the virus when it is not there. While this poses no health risk, it may require additional testing.
Overall, collecting a saliva sample is easy and painless, similar to swabbing the inside of the cheek.12345Why are researchers excited about this trial?
Researchers are excited about the TransmIT Study because it aims to track how cytomegalovirus (CMV) spreads among children and staff in childcare centers. Unlike traditional treatments targeting the virus itself, this study focuses on understanding transmission patterns and immune responses. By mapping how CMV moves through these communities, researchers hope to develop better preventive measures and refine future treatment strategies, making it a groundbreaking approach in managing and potentially reducing CMV transmission.
What evidence suggests that this saliva testing method is effective for detecting CMV?
Research has shown that using saliva samples for a PCR test, which detects the virus's DNA, effectively identifies cytomegalovirus (CMV) infections. Studies have found that saliva PCR can correctly identify over 97% of newborns with CMV. In another study, saliva samples accurately detected all infants with CMV. This method is highly reliable and has demonstrated consistent results in various trials. Saliva testing offers a non-invasive and efficient way to detect CMV, making it a promising screening tool. The trial will include children up to 36 months and staff members in large group childcare centers, where saliva testing will screen for CMV.23678
Who Is on the Research Team?
Laura Gibson, MD
Principal Investigator
UMass Chan Medical School
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observation
Participants complete a health survey and provide one saliva sample for CMV PCR testing
Follow-up
Participants are monitored for safety and effectiveness after sample collection
What Are the Treatments Tested in This Trial?
Interventions
- CMV PCR
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
All staff members in large group childcare centers attended by children participants
Children up to and including 36 months in large group childcare centers in the study network
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Massachusetts, Worcester
Lead Sponsor
ModernaTX, Inc.
Industry Sponsor
Dr. Stephen Hoge
ModernaTX, Inc.
Chief Medical Officer
MD from Harvard Medical School
Stéphane Bancel
ModernaTX, Inc.
Chief Executive Officer since 2011
MBA from Harvard Business School, MSc in Engineering from École Centrale Paris
Citations
Saliva Polymerase-Chain-Reaction Assay for ...
The data reported here show that the same dried-blood-spot PCR protocol applied to saliva identified more than 97% of CMV-infected newborns. In ...
Implementation of pooled saliva tests for universal ...
A study in 2023 described the use of pooled saliva testing in 7,033 newborn infants screened for cCMV over a 2-year period. Yet, this study ...
Diagnosing congenital cytomegalovirus by saliva on ...
Forty-two out of 42 (100 %) CMV positive infants showed positive PCR in the dried saliva on the Guthrie paper. All (100 %) controls exhibited negative PCR ...
4.
journals.lww.com
journals.lww.com/md-journal/fulltext/2022/11250/diagnostic_test_accuracy_of_pcr_by_saliva_specimen.131.aspxDiagnostic test accuracy of PCR by saliva specimen for...
This study aimed to examine the diagnostic accuracy of PCR using saliva samples for newborns with cytomegalovirus infection.
Detection of Congenital Cytomegalovirus Infection by Real ...
Results of saliva PCR and culture were concordant in 78 specimens (97.5%). Two PCR-positive saliva samples were culture negative. These findings demonstrate ...
The Use of Saliva Samples to Test for Congenital ...
Screening programs that undertake testing saliva for CMV DNA may benefit from documenting donor milk use as a potential increased risk for FP results.
139865: Cytomegalovirus (CMV), Congenital, Qualitative ...
Positive results from saliva swab screening for congenital CMV infection are considered presumptively positive and should be confirmed with detection of CMV in ...
Diagnostic value of CMV PCR in saliva compared to urine ...
We compared the diagnostic performance of saliva PCR to urine PCR in infants born to mothers with primary CMV infection during pregnancy.
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