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ACTIVE NOT RECRUITING

NCT05228275

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

Sponsor: Children's Oncology Group

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

6 Months - 37 Years

Study Type

OBSERVATIONAL

Enrollment

549

Start Date

2022-04-08

Completion Date

2027-09-30

Last Updated

2025-12-22

Healthy Volunteers

Conditions

COVID-19 Infection Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

OTHER

Survey Administration

Complete survey

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 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 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

Locations (72)

Children's Hospital of Alabama

Birmingham, Alabama, United States

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

Saint Jude Midwest Affiliate

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

University of Mississippi Medical Center

Jackson, Mississippi, United States

Cardinal Glennon Children's Medical Center

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Las Vegas Urology - Pebble

Henderson, Nevada, United States

Oncology Las Vegas - Henderson

Henderson, Nevada, United States

Las Vegas Urology - Pecos