Evaluation of Immunologic Response Following COVID-19 Vaccination in Children, Adolescents, and Young Adults With Cancer (NCT05228275)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. \>= 6 months and =\< 37 years of age at time of enrollment
2. 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.
3. Note: for this observational study, the decision to vaccinate is according to local discretion and should be made prior to consideration of enrollment
4. Must have a diagnosis of cancer
5. Patient must be undergoing or have previously received one of the following cancer treatments within 12 months before their first COVID-19 vaccine dose:
6. Dosing with chemotherapy or immunotherapy agent, including tyrosine kinase inhibitors and small molecule inhibitors targeting cancer
7. Dosing with monoclonal antibodies targeting B-cell antigens (e.g., Rituximab), or Bruton tyrosine kinase inhibitors or Janus Kinase inhibitors
8. Stem cell infusion for bone marrow transplant or CAR-T infusion for cellular therapy
9. 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
10. 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
11. All patients and/or their parents or legal guardians must sign a written informed consent
12. All institutional, FDA, and National Cancer Institute (NCI) requirements for human studies must be met

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (72 Sites)

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

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.