NCT05228275Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 549 (estimated)
- First submitted
- 4 Feb 2022
- Start date
- 8 Apr 2022
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Children's Oncology Group
- Diseases
- Childhood cancers
- NCT number
- NCT05228275
What you commit to
- Study type: Observational
- Planned participants: 549
- From 8 Apr 2022 to the primary completion date, 30 Sept 2027
- 72 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- \>= 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
Age in the registry: 6 months to 37 years · Sex: All · Does not accept healthy volunteers
Sites (72)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Albany Medical Center Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| C S Mott Children's Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Dell Children's Medical Center of Central Texas Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Sinai Hospital of Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Overlake Medical Center Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Children's Hospital of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| University of Virginia Cancer Center Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| University of Illinois Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Driscoll Children's Hospital Coordinator of this site? Confirm its status | Corpus Christi | United States | Unknown status |
| Dayton Children's Hospital Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Golisano Children's Hospital of Southwest Florida Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| UF Health Cancer Institute - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Saint Vincent Hospital Cancer Center Green Bay Coordinator of this site? Confirm its status | Green Bay | United States | Unknown status |
| Oncology Las Vegas - Henderson Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| Las Vegas Urology - Pebble Coordinator of this site? Confirm its status | Henderson | United States | Unknown status |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Kapiolani Medical Center for Women and Children Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Nemours Children's Clinic-Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Bronson Methodist Hospital Coordinator of this site? Confirm its status | Kalamazoo | United States | Unknown status |
| Kingman Regional Medical Center Coordinator of this site? Confirm its status | Kingman | United States | Unknown status |
| East Tennessee Childrens Hospital Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Las Vegas Urology - Smoke Ranch Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Comprehensive Cancer Centers of Nevada - Town Center Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| University Medical Center of Southern Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Sunrise Hospital and Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Las Vegas Urology - Cathedral Rock Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Summerlin Hospital Medical Center Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Las Vegas Urology - Pecos Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Unknown status |
| Nicklaus Children's Hospital Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| The Children's Hospital at TriStar Centennial Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| UCSF Benioff Children's Hospital Oakland Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Children's Hospital and Medical Center of Omaha Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Nemours Children's Hospital Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Hope Cancer Care of Nevada-Pahrump Coordinator of this site? Confirm its status | Pahrump | United States | Unknown status |
| Saint Joseph's Regional Medical Center Coordinator of this site? Confirm its status | Paterson | United States | Unknown status |
| Sacred Heart Hospital Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| OSF Children's Hospital of Illinois Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Saint Christopher's Hospital for Children Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Drexel University School of Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Children's Hospital of Pittsburgh of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Rhode Island Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Radiation Oncology Associates Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Renown Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Corewell Health Children's Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Methodist Children's Hospital of South Texas Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Rady Children's Hospital - San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Maine Children's Cancer Program Coordinator of this site? Confirm its status | Scarborough | United States | Unknown status |
| Sanford USD Medical Center - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Providence Sacred Heart Medical Center and Children's Hospital Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Mercy Hospital Saint Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Cardinal Glennon Children's Medical Center Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Johns Hopkins All Children's Hospital Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Coordinator of this site? Confirm its status | Sturgeon Bay | United States | Unknown status |
| Madigan Army Medical Center Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Saint Joseph's Hospital/Children's Hospital-Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Children's Hospital at Montefiore Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Montefiore Medical Center-Einstein Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Montefiore Medical Center-Weiler Hospital Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Alfred I duPont Hospital for Children Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.