Spots Global Cancer Trial Database for Evaluation of Immunologic Response Following COVID-19 Vaccination in Children, Adolescents, and Young Adults With Cancer
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Trial Identification
Brief Title: Evaluation of Immunologic Response Following COVID-19 Vaccination in Children, Adolescents, and Young Adults With Cancer
Official Title: Prospective Cohort Study to Evaluate Immunologic Response Following COVID-19 Vaccination in Children, Adolescents and Young Adults With Cancer
Study ID: NCT05228275
Study Description
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.
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.
Keywords
Eligibility
Minimum Age: 6 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, District of Columbia, United States
Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States
University of Florida Health Science Center - 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, Saint 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
Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Beaumont Children's Hospital-Royal Oak, Royal Oak, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Cardinal Glennon Children's Medical Center, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint 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
Las Vegas Urology - Pecos, Las Vegas, Nevada, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
GenesisCare USA - Las Vegas, Las Vegas, Nevada, United States
Sunrise Hospital and Medical Center, Las Vegas, Nevada, United States
Las Vegas Urology - Cathedral Rock, Las Vegas, Nevada, United States
Las Vegas Urology - Smoke Ranch, Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Town Center, Las Vegas, Nevada, United States
Summerlin Hospital Medical Center, Las Vegas, Nevada, United States
Hope Cancer Care of Nevada-Pahrump, Pahrump, Nevada, United States
Renown Regional Medical Center, Reno, Nevada, United States
Radiation Oncology Associates, Reno, Nevada, United States
Saint Joseph's Regional Medical Center, Paterson, New Jersey, United States
Albany Medical Center, Albany, New York, United States
Montefiore Medical Center-Einstein Campus, Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States
Children's Hospital at Montefiore, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Dayton Children's Hospital, Dayton, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Drexel University School of Medicine, Philadelphia, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Saint Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
East Tennessee Childrens Hospital, Knoxville, Tennessee, United States
The Children's Hospital at TriStar Centennial, Nashville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Dell Children's Medical Center of Central Texas, Austin, Texas, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
Overlake Medical Center, Bellevue, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Contact Details
Name: Emad K Salman
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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