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

Sponsor
Children's Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT05228275
Collaborator
National Cancer Institute (NCI) (NIH)
532
Enrollment
30
Locations
32.9
Anticipated Duration (Months)
17.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Other: Survey Administration

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:

  1. 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.

  2. Describe the longer-term impacts of vaccine immune response including subsequent COVID-19-related serious illness.

  3. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
532 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Cohort Study to Evaluate Immunologic Response Following COVID-19 Vaccination in Children, Adolescents and Young Adults With Cancer
Actual Study Start Date :
Apr 4, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

    • Other: Survey Administration
    Complete survey

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients on cancer therapy having humoral immune vaccine response of SARS-CoV-2-specific antibodies [Up to 30 days post completion of primary series of vaccination]

      Measured by immunoassay. Will use the ADVIA Centaur severe acute respiratory syndrome (SARS)-Coronavirus (CoV)-2 immunoglobulin G (IgG) (GCOV2G) assay, which measures IgG. The system reports ADVIA Centaur COV2G assay results in Index Values. The range of 0.5 to 20 Index value is reported as Nonreactive (< 1.00 Index) or Reactive (>= 1.00 Index).

    Secondary Outcome Measures

    1. Proportion of patients that have a humoral immune response [At 30 days after each dose]

      A generalized linear mixed model will be used to describe the presence of immune response to COVID-19 vaccine over time.

    Other Outcome Measures

    1. Post-vaccination symptomatic SARS-CoV-2 infections [Up to 2 years after initial dose]

      The proportion of patients with a post-vaccination symptomatic SARS-CoV-2 infection will be calculated along with a corresponding 95% confidence interval.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 37 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • = 6 months and =< 37 years of age at time of enrollment

    • Patient plans to receive one of the food and drug administration (FDA) approved/FDA-emergency use authorization (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

    • Before the planned initial COVID-19 vaccine dose, patient must be undergoing or have previously received one of the following cancer treatments within 12 months:

    • 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

    • Patient 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

    • Note: for this observational study, the vaccine timing and regimen will proceed according to local discretion. Patients 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Alabama Birmingham Alabama United States 35233
    2 UCSF Benioff Children's Hospital Oakland Oakland California United States 94609
    3 Rady Children's Hospital - San Diego San Diego California United States 92123
    4 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
    5 Golisano Children's Hospital of Southwest Florida Fort Myers Florida United States 33908
    6 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    7 Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
    8 Nemours Children's Clinic-Jacksonville Jacksonville Florida United States 32207
    9 Nemours Children's Hospital Orlando Florida United States 32827
    10 Sacred Heart Hospital Pensacola Florida United States 32504
    11 Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida United States 33607
    12 Kapiolani Medical Center for Women and Children Honolulu Hawaii United States 96826
    13 University of Illinois Chicago Illinois United States 60612
    14 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
    15 Maine Children's Cancer Program Scarborough Maine United States 04074
    16 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    17 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    18 Beaumont Children's Hospital-Royal Oak Royal Oak Michigan United States 48073
    19 University of Mississippi Medical Center Jackson Mississippi United States 39216
    20 Albany Medical Center Albany New York United States 12208
    21 Dayton Children's Hospital Dayton Ohio United States 45404
    22 Saint Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134
    23 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    24 East Tennessee Childrens Hospital Knoxville Tennessee United States 37916
    25 The Children's Hospital at TriStar Centennial Nashville Tennessee United States 37203
    26 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
    27 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    28 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
    29 Madigan Army Medical Center Tacoma Washington United States 98431
    30 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Emad K Salman, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT05228275
    Other Study ID Numbers:
    • ACCL21C2
    • NCI-2022-01919
    • ACCL21C2
    • COG-ACCL21C2
    • ACCL21C2
    • U24CA196173
    • UG1CA189955
    First Posted:
    Feb 8, 2022
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Jul 1, 2022
    Additional relevant MeSH terms:
    COVID-19
    Neoplasms

    Study Results

    No Results Posted as of Aug 18, 2022