Hematopoietic Cell Transplant, Respiratory Viral Infection, Solid Organ Transplant
Conditions
Brief 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 .
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.
Interventions
None listed
Sponsors
St. Jude Children's Research Hospital
Seattle Children's Hospital
The Children's Hospital at Montefiore
National Institute of Allergy and Infectious Diseases (NIAID)
Arkansas Children's Hospital Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants developing a RVI within one-year post transplant. | 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
| Measure | Time frame | Description |
|---|---|---|
| Predicted risk of a post-transplant recipient developing an aRVI within one-year post-transplant | 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 |
| Predicted risk of a post-transplant recipient developing an aRVI from Day 100 to one year post transplant. | 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 |
Countries
United States
Contacts
Primary ContactGabriela Maron, MD
Backup ContactWilliam J. Steinbach, MD
Outcome results
None listed