Clinical Trials Study

N/A

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

Conditions: Hematopoietic Cell Transplant, Solid Organ Transplant, Respiratory Viral Infection

Study #:
NCT05550298
Last Updated:
10/02/2025
Recruitment Status:
Recruiting
Estimated Study Completion Date:
08/01/2029

Summary

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 .

Age: Newborn to 18 Years old

Gender: All

Start Date: 12/13/2022

Primary Completion Date (Estimated): 08/01/2027

Study Completion Date (Estimated): 08/01/2029

Accepts Healthy Volunteers: No

Trial Purpose and 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.

Eligibility Criteria

Age: Newborn to 18 Years old

Gender: All

Accepts Healthy Volunteers: No

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.

Principal Investigator

Betsy Herold, MD

For more information about this study, contact:

Betsy Herold

718-839-7460

betsy.herold@einsteinmed.edu