CompletedNot Applicable

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

United States21 participantsStarted 2022-06-29

Plain-language summary

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.

Who can participate

Age range

24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months after the last vaccine dose

Trial details

NCT IDNCT05164016

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-01

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