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

Completed

Conditions studied: Cancer, Hematopoietic System--Cancer, Transplant-Related Cancer, Solid Tumor Malignancy, Hematologic Malignancy, Solid Organ Transplant, Hematopoietic Cell Transplant, Cellular Therapy

In brief

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.

Key facts

Study ID

NCT05164016

Run by

St. Jude Children's Research Hospital

People needed

21

Starts

2022-06-29

Expected to finish

2026-04-09

Last updated by the study team

2026-04-15

Who can join

Age: any, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Diagnosed with a Hematological Malignancy (Group A), or
• Received a hematopoietic cell transplant or cellular therapy (Group B), or
• Diagnosed with a solid tumor malignancy (Group C).
• Received a solid organ transplant (Group D), or
• Does not have cancer and has not received any type of transplant (Group E)
• Willing and able to provide informed consent

You may not qualify if…

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

Where it is running

• Le Bonheur — Memphis, Tennessee, United States
• LeBonheur — Memphis, Tennessee, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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