Evaluation of Immunologic Response Following COVID-19 Vaccination in Children, Adolescents, and Young Adults With Cancer
Prospective Cohort Study to Evaluate Immunologic Response Following COVID-19 Vaccination in Children, Adolescents and Young Adults With Cancer
5 other identifiers
observational
549
1 country
72
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2022
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedStudy Start
First participant enrolled
April 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
December 22, 2025
April 1, 2025
5.5 years
February 4, 2022
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Seroprevalence of SARS-CoV-2-specific protective antibodies
Will report the proportion of patients with a serologic response to a protocol-approved COVID-19 vaccine, captured using a test for SARS-CoV-2-specific antibodies via immunoassay, and will report a corresponding 95% confidence interval.
24 months following initial vaccination with a protocol-approved COVID-19 vaccine
Other Outcomes (2)
Durability of immune response at 6 months
At 6, 12 and 18 months after each dose
Post-vaccination symptomatic SARS-CoV-2 infections
Up to 2 years after initial dose
Study Arms (1)
Observational (survey, biospecimen collection)
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.
Interventions
Undergo collection of blood samples
Eligibility Criteria
Children and young adults with cancer receiving approved COVID-19 vaccines
You may qualify if:
- \>= 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (72)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
Kingman Regional Medical Center
Kingman, Arizona, 86401, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609, United States
Rady Children's Hospital - San Diego
San Diego, California, 92123, United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida, 32610, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207, United States
Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Nemours Children's Hospital
Orlando, Florida, 32827, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
University of Illinois
Chicago, Illinois, 60612, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637, United States
Maine Children's Cancer Program
Scarborough, Maine, 04074, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Corewell Health Children's
Royal Oak, Michigan, 48073, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, 63104, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, 68114, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Las Vegas Urology - Pebble
Henderson, Nevada, 89074, United States
Oncology Las Vegas - Henderson
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Radiation Oncology Associates
Reno, Nevada, 89509, United States
Saint Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
Albany Medical Center
Albany, New York, 12208, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Dayton Children's Hospital
Dayton, Ohio, 45404, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Drexel University School of Medicine
Philadelphia, Pennsylvania, 19102, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916, United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, 37203, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723, United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78411, United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Overlake Medical Center
Bellevue, Washington, 98004, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
Biospecimen
Blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emad K Salman
Children's Oncology Group
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2022
First Posted
February 8, 2022
Study Start
April 8, 2022
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
December 22, 2025
Record last verified: 2025-04