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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-29

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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