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

Inclusion Criteria:

• >= 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 drugadministration (FDA) approved/FDA-emergency use authorization (EUA) approvedCOVID-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 approvedCOVID-19 vaccines.

• Note: for this observational study, the decision to vaccinate is according tolocal 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 cancertreatments within 12 months before their first COVID-19 vaccine dose:

• Dosing with chemotherapy or immunotherapy agent, including tyrosine kinaseinhibitors 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 cellulartherapy

• A patient enrolling prior to their first COVID-19 vaccine dose is eligible only ifit is feasible to collect required baseline study specimens within protocol mandatedtime period prior to the initial COVID-19 vaccine dose; or a patient who alreadyreceived a COVID-19 vaccine is eligible only if feasible to collect at least onepost-first-dose follow-up specimen (i.e., at minimum, collection of the 24m PFDfollow-up specimen must be feasible as per timing requirements

• Note: for this observational study, the vaccine timing and regimen will proceedaccording to local discretion. Patients enrolled prior to their first COVID-19vaccine dose who do not receive initial vaccine dose within 3 months afterenrollment will be taken off study

• All patients and/or their parents or legal guardians must sign a written informedconsent

• All institutional, FDA, and National Cancer Institute (NCI) requirements for humanstudies must be met

Exclusion Criteria:

• Documented SARS-CoV-2 monoclonal antibody infusion or convalescent plasma afterCOVID-19 infection within last 90 days

• Note: patients with previous COVID-19 infection are eligible as long asrequirements are met. Patients receiving intravenous immunoglobulin therapy (IVIG) therapy (i.e., post bone marrow transplantation [BMT] or chimericantigen receptor [CAR]-T) are eligible

• Patients undergoing radiation therapy only are ineligible

• Reminder: before the planned initial COVID-19 vaccine dose, patient must beundergoing or have received cancer treatments