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

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.

Completed

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Key information

Conditions

Cancer Cellular Therapy Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hematopoietic Cell Transplant Hematopoietic System--Cancer Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Solid Organ Transplant Solid Tumor Malignancy Transplant-Related Cancer

Age range

Up to 24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Le Bonheur, Memphis, Tennessee, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Proportion of participants with immunogenicity following full vaccination (6 months after last dose).

Time frame: 6 months after the last vaccine dose

The primary endpoint is immunogenicity response following full vaccination measured at 6 months after the last vaccine dose. Immunogenicity is defined as a ≥4-fold rise in the GMT of SARS-CoV-2 binding antibody to the spike protein RBD compared to the pre-vaccine baseline level or from a non-detectable GMT at the baseline to a detectable GMT after fully vaccinated. The proportion of participants with immunogenicity following full vaccination (6 months after last dose) will be described for all enrolled patients and for each disease stratum with 95% CIs. Only patients who provide a viable blood sample to evaluate immunogenicity at these time-points following completion of vaccine series will be included in this estimation.

Secondary outcomes

Mean and median antibodies response to COVID-19 vaccination in immunocompromised patients at day 0, second dose, third dose, post last dose (day 180).

Time frame: 6 months after the last vaccine dose

Antibody level at each time point will be summarized with mean with standard deviation and median with range. Linear mixed effect models will be used to assess the longitudinal pattern, with appropriate data transformation if necessary.
Mean and median T cell response to COVID-19 vaccination in immunocompromised patients at day 0, second dose, third dose and post last dose (day 180).

Time frame: 6 months after the last vaccine dose

T-cell response at each time point will be summarized with mean with standard deviation and median with range. Linear mixed effect models will be used to assess the longitudinal pattern, with appropriate data transformation if necessary.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2026
First posted: Dec 20, 2021
Registry last updated: Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed