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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

NCT05164016

CompletedN/A

Sponsor: St. Jude Children's Research Hospital

Conditions: Cancer, Hematopoietic System--Cancer, Transplant-Related Cancer, Solid Tumor Malignancy, Hematologic Malignancy

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: to 24 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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).
Locations (3)
  • Memphis, Tennessee, United States
  • Memphis, Tennessee, United States
  • Memphis, Tennessee, United States