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Evaluating Immune Response to COVID-19 Vaccines in Patients With Cancer, Transplant or Cellular Therapy Recipients

Evaluating Immune Response to COVID-19 Vaccines in Patients With Cancer, Transplant or Cellular Therapy Recipients

Not Recruiting
24 years and younger
All
Phase N/A

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Overview

This study is being done because the investigators would like to learn more about how well the COVID-19 vaccine works in participants with cancer or those who have received a transplant or cellular therapy.

Primary Objective

Assess the immunogenicity to COVID-19 vaccination in patients with cancer and/or transplant and cellular therapy (TCT) recipients.

Secondary Objectives

  • Evaluate the antibodies response to COVID-19 vaccination in immunocompromised patients.
  • Evaluate the T cell response to COVID-19 vaccination in immunocompromised patients.

Exploratory Objectives

  • Assess incidence and severity of COVID-19 infections by 6 months following immunization with a SARS CoV-2 vaccine.
  • Assess the durability immune response to COVID-19 vaccination.
  • Assess the immunogenicity of COVID-19 vaccination in immunocompetent children and adolescents without cancer and have not undergone transplant or received cellular therapy.

Description

The investigator will collect a blood sample (about 1 teaspoon each time) from the participant when the participant receive the COVID-19 vaccine(s) as well as an additional blood samples 6 months after the last COVID-19 vaccine.

The participant will be on the study for about 6 months after the last vaccine. After the six-month blood sample is collected, the participant will be off study.

Eligibility

Inclusion Criteria:

  • Patient receiving care at St. Jude Children's Hospital or Le Bonheur Children's Hospital
  • Less than 24 years old at the time of enrollment (Day 0)
  • Planning to receive a COVID-19 vaccine as part of clinical care
  • Patient is one of the following:
    1. Diagnosed with a Hematological Malignancy (Group A), or
    2. Received a hematopoietic cell transplant or cellular therapy (Group B), or
    3. Diagnosed with a solid tumor malignancy (Group C).
    4. Received a solid organ transplant (Group D), or
    5. Does not have cancer and has not received any type of transplant (Group E)
  • Willing and able to provide informed consent

Exclusion Criteria:

  • Received a COVID-19 vaccine prior to enrollment (Day 0).

Study details
    Cancer
    Hematopoietic System--Cancer
    Transplant-Related Cancer
    Solid Tumor Malignancy
    Hematologic Malignancy
    Solid Organ Transplant
    Hematopoietic Cell Transplant
    Cellular Therapy

NCT05164016

St. Jude Children's Research Hospital

12 December 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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