Evaluation of Immunologic Response Following COVID-19 Vaccination in Children, Adolescents, and Young Adults With Cancer
Purpose
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.
Conditions
- COVID-19 Infection
- Hematopoietic and Lymphatic System Neoplasm
- Malignant Solid Neoplasm
Eligibility
- Eligible Ages
- Between 6 Months and 37 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Children's Hospital of Alabama
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Kingman Regional Medical Center
Kingman, Arizona 86401
Kingman, Arizona 86401
UCSF Benioff Children's Hospital Oakland
Oakland, California 94609
Oakland, California 94609
Rady Children's Hospital - San Diego
San Diego, California 92123
San Diego, California 92123
Contact:
Site Public Contact
858-966-5934
Site Public Contact
858-966-5934
Alfred I duPont Hospital for Children
Wilmington, Delaware 19803
Wilmington, Delaware 19803
Children's National Medical Center
Washington, District of Columbia 20010
Washington, District of Columbia 20010
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida 33908
Fort Myers, Florida 33908
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
Hollywood, Florida 33021
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida 32207
Jacksonville, Florida 32207
Nicklaus Children's Hospital
Miami, Florida 33155
Miami, Florida 33155
Contact:
Site Public Contact
888-624-2778
Site Public Contact
888-624-2778
Nemours Children's Hospital
Orlando, Florida 32827
Orlando, Florida 32827
Sacred Heart Hospital
Pensacola, Florida 32504
Pensacola, Florida 32504
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida 33701
Saint Petersburg, Florida 33701
Tampa General Hospital
Tampa, Florida 33606
Tampa, Florida 33606
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida 33607
Tampa, Florida 33607
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
Honolulu, Hawaii 96826
Contact:
Site Public Contact
808-983-6090
Site Public Contact
808-983-6090
Saint Jude Midwest Affiliate
Peoria, Illinois 61637
Peoria, Illinois 61637
Contact:
Site Public Contact
888-226-4343
Site Public Contact
888-226-4343
Maine Children's Cancer Program
Scarborough, Maine 04074
Scarborough, Maine 04074
Sinai Hospital of Baltimore
Baltimore, Maryland 21215
Baltimore, Maryland 21215
C S Mott Children's Hospital
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125
Site Public Contact
800-865-1125
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Corewell Health Children's
Royal Oak, Michigan 48073
Royal Oak, Michigan 48073
Contact:
Site Public Contact
248-551-7695
Site Public Contact
248-551-7695
University of Mississippi Medical Center
Jackson, Mississippi 39216
Jackson, Mississippi 39216
Contact:
Site Public Contact
601-815-6700
Site Public Contact
601-815-6700
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri 63104
Saint Louis, Missouri 63104
Contact:
Site Public Contact
314-268-4000
Site Public Contact
314-268-4000
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-955-3949
Site Public Contact
402-955-3949
University of Nebraska Medical Center
Omaha, Nebraska 68198
Omaha, Nebraska 68198
University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
GenesisCare USA - Las Vegas
Las Vegas, Nevada 89109
Las Vegas, Nevada 89109
Sunrise Hospital and Medical Center
Las Vegas, Nevada 89109
Las Vegas, Nevada 89109
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada 89135
Las Vegas, Nevada 89135
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Summerlin Hospital Medical Center
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada 89048
Pahrump, Nevada 89048
Renown Regional Medical Center
Reno, Nevada 89502
Reno, Nevada 89502
Radiation Oncology Associates
Reno, Nevada 89509
Reno, Nevada 89509
Saint Joseph's Regional Medical Center
Paterson, New Jersey 07503
Paterson, New Jersey 07503
Albany Medical Center
Albany, New York 12208
Albany, New York 12208
Contact:
Site Public Contact
518-262-5513
Site Public Contact
518-262-5513
Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
Bronx, New York 10461
Montefiore Medical Center-Weiler Hospital
Bronx, New York 10461
Bronx, New York 10461
Children's Hospital at Montefiore
Bronx, New York 10467
Bronx, New York 10467
Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Bronx, New York 10467
Cleveland Clinic Foundation
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Dayton Children's Hospital
Dayton, Ohio 45404
Dayton, Ohio 45404
Contact:
Site Public Contact
800-228-4055
Site Public Contact
800-228-4055
Drexel University School of Medicine
Philadelphia, Pennsylvania 19102
Philadelphia, Pennsylvania 19102
Contact:
Site Public Contact
215-762-3950
Site Public Contact
215-762-3950
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania 19134
Philadelphia, Pennsylvania 19134
Contact:
Site Public Contact
215-427-8991
Site Public Contact
215-427-8991
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
Rhode Island Hospital
Providence, Rhode Island 02903
Providence, Rhode Island 02903
Contact:
Site Public Contact
401-444-1488
Site Public Contact
401-444-1488
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
East Tennessee Childrens Hospital
Knoxville, Tennessee 37916
Knoxville, Tennessee 37916
Contact:
Site Public Contact
865-541-8266
Site Public Contact
865-541-8266
The Children's Hospital at TriStar Centennial
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Contact:
Site Public Contact
615-342-1919
Site Public Contact
615-342-1919
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Site Public Contact
800-811-8480
Site Public Contact
800-811-8480
Dell Children's Medical Center of Central Texas
Austin, Texas 78723
Austin, Texas 78723
Driscoll Children's Hospital
Corpus Christi, Texas 78411
Corpus Christi, Texas 78411
Methodist Children's Hospital of South Texas
San Antonio, Texas 78229
San Antonio, Texas 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
University of Virginia Cancer Center
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington 99204
Spokane, Washington 99204
Madigan Army Medical Center
Tacoma, Washington 98431
Tacoma, Washington 98431
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Marshfield, Wisconsin 54449
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
Sturgeon Bay, Wisconsin 54235-1495
More Details
- NCT ID
- NCT05228275
- Status
- Recruiting
- Sponsor
- Children's Oncology Group
Detailed Description
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.