About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients

Clinicaltrials.gov identifier NCT03924219

Recruitment Status Recruiting

First Posted April 23, 2019

Last update posted September 10, 2020

Study Description

Brief 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 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).

  • Condition or Disease:Heart Transplant Infection
    Kidney Transplant Infection
    Liver Transplant Infection
    CMV
  • Intervention/Treatment: Other: CMV T cell Immunity Assay
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 120 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • 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
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: October 2021
  • Estimated Study Completion Date: March 2022
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: 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.
Other: CMV T cell Immunity Assay
Flow cytometry based assay quantifying IFN-gamma expression in T cells following CMV peptide stimulation (Viracor)
Outcome Measures
  • Primary Outcome Measures: 1. CMV Infection Incidence [ Time Frame: 12 months post-transplantation ]
    CMV Infection as measured by CMV DNAemia or CMV disease
  • Secondary Outcome Measures: 1. Frequency of detectable CMV T cell Immunity [ Time Frame: 12 months post-transplantation ]
    Viracor T cell Immunity Assay
Eligibility Criteria
  • Ages Eligible for Study: up to 17 / (Birth to 17 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Pediatric patients <18 years of age listed or anticipated to undergo kidney, heart, or liver transplantation.
Criteria

Inclusion Criteria:

1. < 18 years of age at the time of pre-transplant enrollment 2. 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 3. Anticipated to receive ≤ 200 days of antiviral chemoprophylaxis Note: Subjects who are consented, enrolled, and undergo transplantation at 200 days of CMV antiviral chemoprophylaxis as part of the
local transplant center's standard CMV prevention protocol

5. History of underlying primary (genetic) T cell immune deficiency

II. Exclusion Criteria post-enrollment A) Removal from study due to minimal risk for CMV
infection

1. 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-).

2. 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. B) Removal from study due to age a. 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.

Contacts and Locations
Contacts

Contact: Daniel Dulek, MD 615-322-2250 daniel.dulek@vumc.org

Locations
Show 12 Study Locations
Sponsors and Collaborators

Vanderbilt University Medical Center

ViraCor Laboratories

Investigators

Principal Investigator: Daniel Dulek, MD Vanderbilt University Medical Center

More Information
  • Responsible Party: Vanderbilt University Medical Center
  • ClinicalTrials.gov Identifier: NCT03924219 History of Changes
  • Other Study ID Numbers: 180947
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: September 10, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Vanderbilt University Medical Center: cmv
  • Additional relevant MeSH terms: Communicable Diseases Infection