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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05228275
Recruitment Status : Recruiting
First Posted : February 8, 2022
Last Update Posted : August 18, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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
COVID-19 Infection Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm Procedure: Biospecimen Collection Other: Survey Administration

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.

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Study Type : Observational
Estimated 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 : April 4, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Proportion of patients on cancer therapy having humoral immune vaccine response of SARS-CoV-2-specific antibodies [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 37 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and young adults with cancer receiving approved COVID-19 vaccines
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05228275


Locations
Show Show 30 study locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Emad K Salman Children's Oncology Group
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT05228275    
Other Study ID Numbers: ACCL21C2
NCI-2022-01919 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACCL21C2 ( Other Identifier: Children's Oncology Group )
COG-ACCL21C2 ( Other Identifier: DCP )
ACCL21C2 ( Other Identifier: CTEP )
U24CA196173 ( U.S. NIH Grant/Contract )
UG1CA189955 ( U.S. NIH Grant/Contract )
First Posted: February 8, 2022    Key Record Dates
Last Update Posted: August 18, 2022
Last Verified: July 2022
Additional relevant MeSH terms:
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COVID-19
Neoplasms
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases