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

Recruiting

• Conditions: COVID-19 Infection; Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

• Registration Number: NCT05228275
• Lead Sponsor: Children's Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-2-4
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 549

Inclusion Criteria

Inclusion Criteria:<br><br> - >= 6 months and =< 37 years of age at time of enrollment<br><br> - Patient plans to receive their first COVID-19 vaccine dose one of the food and drug<br> administration (FDA) approved/FDA-emergency use authorization (EUA) approved<br> COVID-19 vaccines OR patient already received their first COVID-19 vaccine dose =<<br> 24 months prior to enrollment using one of the FDA approved/FDA-EUA approved<br> COVID-19 vaccines.<br><br> - Note: for this observational study, the decision to vaccinate is according to<br> local discretion and should be made prior to consideration of enrollment<br><br> - Must have a diagnosis of cancer<br><br> - Patient must be undergoing or have previously received one of the following cancer<br> treatments within 12 months before their first COVID-19 vaccine dose:<br><br> - Dosing with chemotherapy or immunotherapy agent, including tyrosine kinase<br> inhibitors and small molecule inhibitors targeting cancer<br><br> - Dosing with monoclonal antibodies targeting B-cell antigens (e.g., Rituximab),<br> or Bruton tyrosine kinase inhibitors or Janus Kinase inhibitors<br><br> - Stem cell infusion for bone marrow transplant or CAR-T infusion for cellular<br> therapy<br><br> - A patient enrolling prior to their first COVID-19 vaccine dose is eligible only if<br> it is feasible to collect required baseline study specimens within protocol mandated<br> time period prior to the initial COVID-19 vaccine dose; or a patient who already<br> received a COVID-19 vaccine is eligible only if feasible to collect at least one<br> post-first-dose follow-up specimen (i.e., at minimum, collection of the 24m PFD<br> follow-up specimen must be feasible as per timing requirements<br><br> - Note: for this observational study, the vaccine timing and regimen will proceed<br> according to local discretion. Patients enrolled prior to their first COVID-19<br> vaccine dose who do not receive initial vaccine dose within 3 months after<br> enrollment will be taken off study<br><br> - All patients and/or their parents or legal guardians must sign a written informed<br> consent<br><br> - All institutional, FDA, and National Cancer Institute (NCI) requirements for human<br> studies must be met<br><br>Exclusion Criteria:<br><br> - Documented SARS-CoV-2 monoclonal antibody infusion or convalescent plasma after<br> COVID-19 infection within last 90 days<br><br> - Note: patients with previous COVID-19 infection are eligible as long as<br> requirements are met. Patients receiving intravenous immunoglobulin therapy<br> (IVIG) therapy (i.e., post bone marrow transplantation [BMT] or chimeric<br> antigen receptor [CAR]-T) are eligible<br><br> - Patients undergoing radiation therapy only are ineligible<br><br> - Reminder: before the planned initial COVID-19 vaccine dose, patient must be<br> undergoing or have received cancer treatments

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seroprevalence of SARS-CoV-2-specific protective antibodies