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NCT Number: NCT05550298

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 .

Recruiting

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Key information

Conditions

Hematopoietic Cell Transplant Respiratory Viral Infection Solid Organ Transplant

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham's (UAB), Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Recipient Inclusion Criteria

  • Less than 18 years at the time of anticipated transplant
  • Participant meets one of the following criteria:
  • scheduled to receive allogeneic hematopoietic cell transplant within 14 days of enrollment or
  • 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.

Treatment and study plan

Primary outcomes

  1. Proportion of participants developing a RVI within one-year post transplant.

    Time frame: Baseline through 1-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.

Secondary outcomes

  1. Predicted risk of a post-transplant recipient developing an aRVI within one-year post-transplant

    Time frame: 1 year

    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

  2. Predicted risk of a post-transplant recipient developing an aRVI from Day 100 to one year post transplant.

    Time frame: Day +100 through 1-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

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriela Maron, MD

CONTACT

[email protected]

866-278-5833

William J. Steinbach, MD

CONTACT

[email protected]

501-364-5262

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Collaborators

  • Children's Hospital at Montefiore
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Seattle Children's Hospital
  • St. Jude Children's Research Hospital

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Sep 22, 2022
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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