Evaluation of Immunologic Response Following COVID-19 Vaccination in Children, Adolescents, and Young Adults With Cancer

Running, not enrolling

Conditions studied: COVID-19 Infection, Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm

In brief

This study evaluates immunologic response following COVID-19 vaccination in children, adolescents, and young adults with cancer. Vaccines work by stimulating the body's immune cells to respond against a specific disease. The immune response produces protection from that disease. Effects from cancer and from treatments for cancer can reduce the body's natural disease fighting ability (called immunity). Factors such as vaccine type, timing of vaccine dosing related to treatment for cancer and number of vaccine doses or "boosts" (extra vaccine shots) may strengthen or diminish the body's protective immune response. This study may help researchers learn more about how the body's immune system responds to the COVID-19 vaccine when the vaccination is given during or after cancer treatment.

Key facts

Study ID

NCT05228275

Run by

Children's Oncology Group

People needed

549

Starts

2022-04-08

Expected to finish

2028-03-31

Last updated by the study team

2026-07-16

Who can join

Age: 1 and older, up to 37. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >= 6 months and =< 37 years of age at time of enrollment
• Patient plans to receive their first COVID-19 vaccine dose one of the food and drug administration (FDA) approved/FDA-emergency use authorization (EUA) approved COVID-19 vaccines OR patient already received their first COVID-19 vaccine dose =< 24 months prior to enrollment using one of the FDA approved/FDA-EUA approved COVID-19 vaccines.
• Note: for this observational study, the decision to vaccinate is according to local discretion and should be made prior to consideration of enrollment
• Must have a diagnosis of cancer
• Patient must be undergoing or have previously received one of the following cancer treatments within 12 months before their first COVID-19 vaccine dose:
• Dosing with chemotherapy or immunotherapy agent, including tyrosine kinase inhibitors and small molecule inhibitors targeting cancer
• Dosing with monoclonal antibodies targeting B-cell antigens (e.g., Rituximab), or Bruton tyrosine kinase inhibitors or Janus Kinase inhibitors
• Stem cell infusion for bone marrow transplant or CAR-T infusion for cellular therapy
• A patient enrolling prior to their first COVID-19 vaccine dose is eligible only if it is feasible to collect required baseline study specimens within protocol mandated time period prior to the initial COVID-19 vaccine dose; or a patient who already received a COVID-19 vaccine is eligible only if feasible to collect at least one post-first-dose follow-up specimen (i.e., at minimum, collection of the 24m PFD follow-up specimen must be feasible as per timing requirements
• Note: for this observational study, the vaccine timing and regimen will proceed according to local discretion. Patients enrolled prior to their first COVID-19 vaccine dose who do not receive initial vaccine dose within 3 months after enrollment will be taken off study
• All patients and/or their parents or legal guardians must sign a written informed consent
• All institutional, FDA, and National Cancer Institute (NCI) requirements for human studies must be met

You may not qualify if…

• Documented SARS-CoV-2 monoclonal antibody infusion or convalescent plasma after COVID-19 infection within last 90 days
• Note: patients with previous COVID-19 infection are eligible as long as requirements are met. Patients receiving intravenous immunoglobulin therapy (IVIG) therapy (i.e., post bone marrow transplantation [BMT] or chimeric antigen receptor [CAR]-T) are eligible
• Patients undergoing radiation therapy only are ineligible
• Reminder: before the planned initial COVID-19 vaccine dose, patient must be undergoing or have received cancer treatments

Where it is running

• Kingman Regional Medical Center — Kingman, Arizona, United States
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
• UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
• Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Sacred Heart Hospital — Pensacola, Florida, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• University of Illinois — Chicago, Illinois, United States
• OSF Children's Hospital of Illinois — Peoria, Illinois, United States
• Maine Children's Cancer Program — Scarborough, Maine, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• C S Mott Children's Hospital — Ann Arbor, Michigan, United States
• Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
• Bronson Methodist Hospital — Kalamazoo, Michigan, United States
• Corewell Health Children's — Royal Oak, Michigan, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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