Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients

The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT).

Primary Objective

To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors.

Secondary Objectives:

• To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors.
• To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors .

Study Overview

• Status: Recruiting
• Conditions: Solid Organ Transplant; Respiratory Viral Infection; Hematopoietic Cell Transplant

Detailed Description

The investigators will collect a nasal swab and blood sample from the participant when the participant is enrolled on the study and if the participant develops a RVI in the first year after transplant. The investigators will collect a blood sample 100 days after the participant's transplant.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Gabriela Maron, MD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org
• Study Contact Backup: Name: William J. Steinbach, MD; Phone Number: 501-364-5262; Email: wsteinbach@uams.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham's (UAB)
      • Contact: Maria Rueda Altez, MD; Phone Number: 205-638-2599; Email: mruedaaltez@uabmc.edu
      • Principal Investigator: Maria Rueda Altez, MD
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Recruiting
      • Arkansas Children's Hospital
      • Contact: William J. Steinbach, MD; Phone Number: 501-364-5262; Email: wsteinbach@uams.edu
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • Children's National Medical
      • Contact: Benjamin Hanisch, MD; Phone Number: 202-476-5051; Email: Bhanisch@childrensnational.org
      • Principal Investigator: Benjamin Hanisch, MD
  • Florida
    • Miami, Florida, United States, 33146
      • Recruiting
      • University if Miami
      • Contact: Ivan Gonzalez, MD; Email: i.gonzalez2@med.miami.edu
      • Principal Investigator: Ivan Gonzalez, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory and Children's Healthcare of Atlanta
      • Contact: Kathryn Goggin, MD; Phone Number: 404-785-5437; Email: kathryn.pearl.goggin@emory.edu
      • Principal Investigator: Kathryn Goggin, MD
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medicine Comer Children's Hospital
      • Contact: Madan Kumar, MD; Phone Number: 773-702-7087; Email: mkumar@peds.bsd.uchicago.edu
      • Principal Investigator: Madan Kumar
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville
      • Contact: Victoria Statler, MD
      • Principal Investigator: Victoria Statler, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Tanvi Sharma, MD; Phone Number: 617-919-2900; Email: Tanvi.Sharma@childrens.harvard.edu
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • C.S. Mott Children's Hospital
      • Contact: Jason Weinberg,, MD; Phone Number: 734-764-6265; Email: jbwein@med.umich.edu
      • Principal Investigator: Jason Weinberg,, MD
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Children's Hospital of Michigan
      • Contact: Arora Harbir, MD; Phone Number: 313-745-5219; Email: arora1hs@cmich.edu
      • Principal Investigator: Arora Harbir, MD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Beth Thielen, MD., PhD; Phone Number: 612-626-5637; Email: thie0149@umn.edu
      • Principal Investigator: Beth Thielen, MD., PhD
  • Missouri
    • St Louis, Missouri, United States, 63105
      • Recruiting
      • Washington University
      • Contact: Carol M Kao, MD; Phone Number: 314-273-4687; Email: kaoc@wustl.edu
      • Principal Investigator: Carol M Kao, MD
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Kari Neeman, MD; Phone Number: 402-559-4000; Email: kneemann@unmc.edu
      • Principal Investigator: Kari Neeman, MD
  • New York
    • The Bronx, New York, United States, 10467
      • Recruiting
      • The Children's Hospital at Montefiore
      • Contact: Marc Foca, MD; Phone Number: 718-741-2470; Email: mfoca@montefiore.org
      • Principal Investigator: Marc Foca, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Lara Danziger-Isakov, MD; Phone Number: 513-636-7499; Email: Lara.Danziger-Isakov@cchmc.org
    • Columbus, Ohio, United States, 43205
      • Recruiting
      • Nationwide Children's Hospital
      • Contact: Masako Shimamura, MD; Phone Number: 614-722-4452
      • Principal Investigator: Masako Shimamura, MD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • UPMC
      • Contact: Johnathan Albert, MD; Phone Number: 412-692-3021; Email: albertjd1@upmc.edu
      • Contact: ISAAC CASON; Phone Number: 412-692-7351; Email: casoni@upmc.edu
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Lauren Powell, DO; Phone Number: 843-792-9909; Email: powellau@musc.edu
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St. Jude Children's Research Hospital
      • Contact: Gabriela Maron, MD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org
      • Principal Investigator: Gabriela Maron, MD
      • Principal Investigator: William J Steinbach, MD
    • Memphis, Tennessee, United States, 38103
      • Recruiting
      • Le Bonheur Children's Hospital
      • Contact: Timothy Minniear, MD; Phone Number: 901-287-5374; Email: tminniea@uthsc.edu
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • UT Le Bonheur
      • Contact: Timothy Minniear, MD; Phone Number: 901-287-5374; Email: tminniea@uthsc.edu
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Recruiting
      • Cook Children's
      • Contact: marysuzanne.whitworth@cookchildrens.org S. Whitworth, MD; Phone Number: 682-885-1485; Email: marysuzanne.whitworth@cookchildrens.org
    • Houston, Texas, United States, 77030
      • Recruiting
      • Baylor College of Medicine
      • Contact: Elizabeth Moulton, MD; Phone Number: 832-824-4330; Email: emoulton@bcm.edu
      • Principal Investigator: Elizabeth Moulton, MD
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Center Center
      • Contact: Natalie D Garnes, MD; Phone Number: 713-745-0855; Email: njdailey@mdanderson.org
      • Contact: Jennifer Jackson; Phone Number: 346-725-1272; Email: jrjackson1@mdanderson.org
      • Principal Investigator: Natalie D Garnes, MD
    • Houston, Texas, United States, 77225-0036
      • Recruiting
      • UTHealth Houston
      • Contact: Ramia Zakhour, MD; Phone Number: 713-500-5714; Email: ramia.g.zakhour@uth.tmc.edu
      • Principal Investigator: Ramia Zakhour, MD
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Childrens
      • Contact: Alpana Waghmare, MD; Phone Number: 206-987-6558; Email: awaghmar@fredhutch.org
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Children's Hospital of Wisconsin
      • Contact: Anna Huppler, MD; Phone Number: 414-337-7090; Email: ahuppler@mcw.edu
      • Principal Investigator: Anna Huppler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All participants who meet eligibility criteria and consent to enrollment on the study.

Description

Recipient Inclusion Criteria

• Less than 18 years at the time of anticipated transplant

• Participant meets one of the following criteria:

  1. scheduled to receive allogeneic hematopoietic cell transplant within 14 days of enrollment or
  2. Scheduled to or received solid organ transplant within 7 days before or after enrollment
• Participant is receiving care at the time of enrollment at one of the study participating institutions.
• Parent/guardian willing and able to provide informed consent, and if appropriate, child willing and able to provide informed assent.

Donor Inclusion Criteria

• Donor for HCT recipient enrolled on the VIPER study.
• Willing and able to provide informed consent.

Exclusion Criteria:

Recipient Exclusion Criteria

None

Donor Exclusion Criteria

• Is not an HCT donor for a participant enrolled on the VIPER study.
• Not available to provide pre-transplant research blood sample.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hematopoietic Cell Transplantation (HCT); Early and accurate diagnosis of respiratory viral infections (RVIs) in children and adolescents who have undergone HCT is important for improving outcomes. The investigators are doing this study to understand more about how RVIs affect children who receive a transplant.
Solid Organ Transplant (SOT); Early and accurate diagnosis of respiratory viral infections (RVIs) in children and adolescents who have undergone SOT is important for improving outcomes. The investigators are doing this study to understand more about how RVIs affect children who receive a transplant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants developing a RVI within one-year post transplant.	Prevalence is estimated as the proportion of HCT or SOT participants with a positive PCR pre-transplant screen who develop any RVI within one year post transplant. A 95% confidence interval will be provided.	Baseline through 1-year post-transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predicted risk of a post-transplant recipient developing an aRVI within one-year post-transplant	Risk will be predicted by the development of a pre-transplant immunology model utilizing measurements of pre-transplant quantitative immunology (recipient and donor) and RSV/PIV3/HMPV/SARS-CoV-2 RVI from pre-transplant to year one post-transplant	1 year
Predicted risk of a post-transplant recipient developing an aRVI from Day 100 to one year post transplant.	Risk will be predicted by the development of a pre-transplant immunology model utilizing measurements of Day 100 quantitative immunology (recipient and donor) and RSV/PIV3/HMPV/SARS-CoV-2 RVI from Day 100 to year one post-transplant	Day +100 through 1-year post-transplant

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Seattle Children's Hospital; St. Jude Children's Research Hospital; The Children's Hospital at Montefiore
• Investigators: Principal Investigator: Gabriela Maron, MD, St. Jude Children's Research Hospital; Principal Investigator: William J. Steinbach, MD, Arkansas Children's Hospital Research Institute

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Virus Diseases
• Other Study ID Numbers: VIPER; 7R01AI159684-02 (U.S. NIH Grant/Contract); NCI-2022-08554 (Other Identifier: National Institute of Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No