Prospective Cohort Study to Evaluate Immunologic Response Following COVID-19 Vaccination in Children, Adolescents and Young Adults with Cancer
Categories (click each to see list of all clinical trials associated with that category): Pediatric (PEDONC)
Current Status: Open
Phase: N/A (Cancer Control)
Principal Investigator: Beck, Jill
Contact Information:
Angie Boettner
aboettner@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05228275?term=NCT05228275&rank=1#participation-criteria
Summary
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.