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

Arkansas Children's Hospital Research Institute

Status: Enrolling

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05550298

NCI-2022-08554 (Other Identifier)

7R01AI159684-02 (U.S. NIH Grant/Contract)

VIPER

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

2,000 participants in 2 patient groups

Hematopoietic Cell Transplantation (HCT)

Description:

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)

Description:

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.