Heart Transplant InfectionNCT03924219
CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients
An observational study of Heart Transplant Infection and Kidney Transplant Infection, run by Vanderbilt University Medical Center at 12 sites in United States.
Trial summary
CMV infection and disease remain a significant clinical challenge for pediatric solid organ transplant (SOT) recipients. Current prevention strategies are limited to prophylaxis in which antiviral medication is administered for a period of several months or preemption in which close monitoring of CMV viral load from… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Heart Transplant Infection, Kidney Transplant Infection, Liver Transplant Infection
- What is being tested?
- CMV T cell Immunity Assay
- How many people
- 161 participants
- Where
- 12 sitesUnited States
- Study dates
- 3 Jun 2019to 1 Jul 2025
- 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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients <18 years of age listed or anticipated to undergo kidney, heart, or liver transplantation.
Who may be able to join
- < 18 years of age at the time of pre-transplant enrollment
- Potential subject is undergoing evaluation or is currently listed for isolated heart, kidney, or liver transplantation at a participating transplant center OR is anticipated to undergo living-donor kidney or liver transplantation
- Anticipated to receive ≤ 200 days of antiviral chemoprophylaxis
- Note: Subjects who are consented, enrolled, and undergo transplantation at <18 years of age will remain in the study and be followed post-transplant according to the study plan after they turn 18 years of age. Subjects will be re-consented to remain in the study at their first study visit after turning 18 years of age.
Who cannot join
- Exclusion Criteria pre-transplant
- Prior history of any organ transplant
- Prior history of hematopoietic cell transplant
- Anticipated to receive more than one organ at the time of transplant
- Anticipated to receive > 200 days of CMV antiviral chemoprophylaxis as part of the local transplant center's standard CMV prevention protocol
- History of underlying primary (genetic) T cell immune deficiency
Show all 11Show fewer
- Exclusion Criteria post-enrollment A) Removal from study due to minimal risk for CMV infection
- CMV seronegative children >= 12 months of age will be enrolled pre-transplant but will subsequently be excluded from the study IF they receive an organ from a CMV seronegative donor (CMV D-/R-).
- Infants <12 months will be considered seronegative regardless of their CMV IgG status (whether or not this testing was obtained by the local transplant center) UNLESS the infant has a positive pre-transplant CMV culture (from urine) or a positive pre-transplant CMV PCR (from urine, saliva, or blood). Infants <12 months of age without evidence of prior CMV infection (as defined by these preceding criteria) will be excluded from post-transplant follow up IF they receive an organ from a CMV seronegative donor due to low risk for post-transplant CMV infection. Infants <12 months of age with evidence of prior CMV infection (as defined above) will remain in the study following transplantation.
- Removal from study due to age
- Subjects who are enrolled at <18 years of age but are not transplanted prior to their 18th birthday will be removed from the study and will not have further pre- or post-transplant follow up.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Emory University Medical Center/Children's Hospital of Atlanta
Atlanta, Georgia, 30322
Boston Children's Hospital
Boston, Massachusetts, 02115
Northwestern University Medical Center/Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke University Medical Center/Duke Children's Hosptial
Durham, North Carolina, 27710
Children's Mercy Hospital
Kansas City, Missouri, 64108
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Albert Einstein College of Medicine/Children's Hospital at Montefiore
New York, New York, 10467
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center/Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Stanford University Medical Center/Lucile Packard Children's Hospital Stanford
Stanford, California, 94305
About this study
Official title: Assessment of CMV-specific T Cell Responses by Flow Cytometry With Intracellular Cytokine Staining to Predict CMV Infection Risk in Pediatric Solid Organ Transplant Recipients
CMV infection and disease remain a significant clinical challenge for pediatric solid organ transplant (SOT) recipients. Current prevention strategies are limited to prophylaxis in which antiviral medication is administered for a period of several months or preemption in which close monitoring of CMV viral load from the peripheral blood is performed and treatment is initiated when CMV is detected. Each of these strategies has risks, costs, and limitations associated with it. Recently, assays for measurement of an individual patient's CMV immunity have been developed and are clinically available. One of these is the Viracor CMV T cell Immunity Panel. This flow cytometry based assay is performed on peripheral blood and measures cytokine release in response to CMV antigen stimulation by flow cytometry. The thresholds for this assay that confer protection against CMV infection in pediatric SOT recipients are not known. Defining CMV-specific cell mediated immune response thresholds that confer protection against CMV reactivation could inform patient specific durations of antiviral prophylaxis or pre-emptive surveillance testing. Therefore, the objective of this study is to quantify CMVresponsive T lymphocyte populations by flow cytometry (Viracor CMV T cell Immunity Panel) in pediatric heart, kidney, and liver transplant recipients within the first year of transplantation and to investigate potential threshold values that correlate with protection against CMV infection (DNAemia).
- Being tested
- CMV T cell Immunity Assay
- Keywords
- cmv
- 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 T cell Immunity AssayOther
Flow cytometry based assay quantifying IFN-gamma expression in T cells following CMV peptide stimulation (Viracor)
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Solid Organ Transplant (SOT) Recipients | Pediatric patients (<18 years of age) undergoing or anticipated to undergo solid organ transplantation (heart, kidney, or liver) will be prospectively enrolled with serial blood collection for CMV T cell Immunity Assay performance. Receives: Other: CMV T cell Immunity Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV Infection Incidence
CMV Infection as measured by CMV DNAemia or CMV disease
Measured: 12 months post-transplantation
Secondary outcomes (1)
Frequency of detectable CMV T cell Immunity
Viracor T cell Immunity Assay
Measured: 12 months post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start3 Jun 2019
- Primary completion1 Aug 2024
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant InfectionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ViraCor Laboratories
- Responsible party
- Principal investigator, Daniel Dulek, Vanderbilt University Medical Center
- Investigators
- Daniel Dulek, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924219
- Sponsor's protocol ID
- 180947
- Status last verified
- Mar 2026
- First submitted
- 18 Apr 2019
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of CMV-specific T Cell Responses by Flow Cytometry With Intracellular Cytokine Staining to Predict CMV Infection Risk in Pediatric Solid Organ Transplant Recipients
- ClinicalTrials.gov ID
- NCT03924219
- Acronym / sponsor ID
- 180947
- Keywords
- cmv
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- ViraCor Laboratories
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 23 Apr 2019 (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.
CMV infection and disease remain a significant clinical challenge for pediatric solid organ transplant (SOT) recipients. Current prevention strategies are limited to prophylaxis in which antiviral medication is administered for a period of several months or preemption in which close monitoring of CMV viral load from the peripheral blood is performed and treatment is initiated when CMV is detected. Each of these strategies has risks, costs, and limitations associated with it. Recently, assays for measurement of an individual patient's CMV immunity have been developed and are clinically available. One of these is the Viracor CMV T cell Immunity Panel. This flow cytometry based assay is performed on peripheral blood and measures cytokine release in response to CMV antigen stimulation by flow cytometry. The thresholds for this assay that confer protection against CMV infection in pediatric SOT recipients are not known. Defining CMV-specific cell mediated immune response thresholds that confer protection against CMV reactivation could inform patient specific durations of antiviral prophylaxis or pre-emptive surveillance testing. Therefore, the objective of this study is to quantify CMVresponsive T lymphocyte populations by flow cytometry (Viracor CMV T cell Immunity Panel) in pediatric heart, kidney, and liver transplant recipients within the first year of transplantation and to investigate potential threshold values that correlate with protection against CMV infection (DNAemia).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Solid Organ Transplant (SOT) Recipients | – | Other: CMV T cell Immunity AssayPediatric patients (<18 years of age) undergoing or anticipated to undergo solid organ transplantation (heart, kidney, or liver) will be prospectively enrolled with serial blood collection for CMV T cell Immunity Assay performance. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients <18 years of age listed or anticipated to undergo kidney, heart, or liver transplantation.
Key inclusion criteria (4 listed)
- < 18 years of age at the time of pre-transplant enrollment
- Potential subject is undergoing evaluation or is currently listed for isolated heart, kidney, or liver transplantation at a participating transplant center OR is anticipated to undergo living-donor kidney or liver transplantation
- Anticipated to receive ≤ 200 days of antiviral chemoprophylaxis
- Note: Subjects who are consented, enrolled, and undergo transplantation at <18 years of age will remain in the study and be followed post-transplant according to the study plan after they turn 18 years of age. Subjects will be re-consented to remain in the study at their first study visit after turning 18 years of age.
Key exclusion criteria (11 listed)
- Exclusion Criteria pre-transplant
- Prior history of any organ transplant
- Prior history of hematopoietic cell transplant
- Anticipated to receive more than one organ at the time of transplant
- Anticipated to receive > 200 days of CMV antiviral chemoprophylaxis as part of the local transplant center's standard CMV prevention protocol
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 T cell Immunity AssayFlow cytometry based assay quantifying IFN-gamma expression in T cells following CMV peptide stimulation (Viracor) | Other | Pediatric Solid Organ Transplant (SOT) Recipients |
Primary outcome
CMV Infection Incidence
Time frame: 12 months post-transplantation
CMV Infection as measured by CMV DNAemia or CMV disease
1 secondary outcome
Frequency of detectable CMV T cell Immunity
Time frame: 12 months post-transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Daniel Dulek, MD principal investigator
Vanderbilt University Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplant Infection and Kidney Transplant Infection, run by Vanderbilt University Medical Center at 12 sites 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 4 inclusion and 11 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: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CMV Infection Incidence (time frame: 12 months post-transplantation). 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 27 Mar 2026.