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

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVE: I. Characterize the immunologic response following severe acute respiratory syndrome (SARS)-coronavirus (CoV)-2 vaccination in children, adolescents, and young adults with cancer who are currently receiving or who recently completed treatment with immunosuppressive therapy. EXPLORATORY OBJECTIVES: I. Describe the rate of post-vaccination symptomatic SARS-CoV-2 infections. II. Assess the durability of immune response to SARS-CoV-2 vaccine over 2 years. III. Describe the longer-term impacts of vaccine immune response including subsequent COVID-19-related serious illness. IV. To help guide future vaccine dosing and timing, at each SARS-CoV-2 vaccine dose administration determine the degree of: IVa. Lymphopenia (absolute lymphocyte count cells/mm^3); IVb. Helper T-cell suppression (CD4 count); IVc. B-cell suppression (CD19 count). V. Provide a mechanism for data collection and banking of biospecimens for use in research regarding immune response to SARS-CoV-2 vaccination. OUTLINE: Patients receive COVID-19 vaccine per standard of care. Patients also complete a survey at 1 month and undergo collection of blood samples at 1, 3, 6, 12, 18, and 24 months. Patients may complete an additional survey at 1 month after each vaccine boost and undergo collection of blood samples before each vaccine boost, 1 month after each vaccine boost, and at the time of COVID-19 infection.

Official Title
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Prospective Cohort Study to Evaluate Immunologic Response Following COVID-19 Vaccination in Children, Adolescents and Young Adults With Cancer

Conditions
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Malignant Solid Neoplasm, COVID-19 Infection, Hematopoietic and Lymphoid System Neoplasm

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 6 months and =< 37 years of age at time of enrollment Patient plans to receive one of the food and drug administration (FDA) approved/FDA-emergency use authorization (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 Before the planned initial COVID-19 vaccine dose, patient must be undergoing or have previously received one of the following cancer treatments within 12 months: 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 Patient 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 Note: for this observational study, the vaccine timing and regimen will proceed according to local discretion. Patients 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 37 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (survey, biospecimen collection)<br>Patients receive COVID-19 vaccine per standard of care. Patients also complete a survey at 1 month and undergo collection of blood samples at 1, 3, 6, 12, 18, and 24 months. Patients may complete an additional survey at 1 month after each vaccine boost and undergo collection of blood samples before each vaccine boost, 1 month after each vaccine boost, and at the time of COVID-19 infection. | Procedure: Biospecimen Collection<br>* Undergo collection of blood samples<br>* Other names: Specimen Collection;Other: Survey Administration<br>* Complete survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on cancer therapy having humoral immune vaccine response of SARS-CoV-2-specific antibodies | Measured by immunoassay. Will use the ADVIA Centaur severe acute respiratory syndrome (SARS)-Coronavirus (CoV)-2 immunoglobulin G (IgG) (GCOV2G) assay, which measures IgG. The system reports ADVIA Centaur COV2G assay results in Index Values. The range of 0.5 to 20 Index value is reported as Nonreactive (< 1.00 Index) or Reactive (>= 1.00 Index). | Up to 30 days post completion of primary series of vaccination |