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 .
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.
Is not an HCT donor for a participant enrolled on the VIPER study.
Not available to provide pre-transplant research blood sample.
All participants who meet eligibility criteria and consent to enrollment on the study.
Cohort
Prospective
Not listed
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.
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
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
Click on the lead sponsor to view all of their trials.
Arkansas Children's Hospital Research Institute
Lead sponsor
St. Jude Children's Research Hospital
Collaborator
Seattle Children's Hospital
Collaborator
Children's Hospital at Montefiore
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
