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

St. Jude Children's Research Hospital

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other

Identifiers

NCT05164016

COVVIR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: Under 24 years old

Volunteers: No Healthy Volunteers

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).