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 .
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 .
Brief Title
Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
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.
Central Contacts
Central Contact Role
Contact
Central Contact Phone
866-278-5833
Central Contact Email
referralinfo@stjude.org
Central Contact Role
Contact
Central Contact Phone
501-364-5262
Central Contact Email
wsteinbach@uams.edu
Completion Date
Completion Date Type
Estimated
Conditions
Hematopoietic Cell Transplant
Solid Organ Transplant
Respiratory Viral Infection
Eligibility 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.
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
18 Years
NCT Id
NCT05550298
Org Class
Other
Org Full Name
Arkansas Children's Hospital Research Institute
Org Study Id
VIPER
Overall Status
Recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients
Primary Outcomes
Outcome Description
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.
Outcome Measure
Proportion of participants developing a RVI within one-year post transplant.
Outcome Time Frame
Baseline through 1-year post-transplant
Secondary Ids
Secondary Id
7R01AI159684-02
Secondary Id
NCI-2022-08554
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
1 year
Outcome Measure
Predicted risk of a post-transplant recipient developing an aRVI within one-year post-transplant
Outcome Description
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
Outcome Time Frame
Day +100 through 1-year post-transplant
Outcome Measure
Predicted risk of a post-transplant recipient developing an aRVI from Day 100 to one year post transplant.
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
All participants who meet eligibility criteria and consent to enrollment on the study.
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
18
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Betsy Herold
Investigator Email
betsy.herold@einsteinmed.edu
Investigator Phone
718-839-7460