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VIPER

  • Status
    Accepting Candidates
  • Age
    N/A - 18 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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 .

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.

Details

Full study title MULTI-CENTER MOLECULAR DIAGNOSIS AND HOST RESPONSE OF RESPIRATORY VIRAL INFECTIONS IN PEDIATRIC TRANSPLANT RECIPIENTS (VIPER), NIH Grant Number: R01AI159684
Protocol number OCR50427
ClinicalTrials.gov ID NCT05550298

Eligibility

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.

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.