RecruitingPhase 2NCT04948619

Immune Function and Response to Vaccination After Cancer Therapy in Pediatric Patients

Immune Function and Response to Vaccination Following Completion of Cancer Directed Systemic Therapy in Pediatric Patients With Cancer


Sponsor

Wake Forest University Health Sciences

Enrollment

64 participants

Start Date

Aug 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Pediatric cancer survivors have increased infection-related morbidity and mortality. This study will evaluate immune dysfunction following cancer directed systemic therapy completion, with attention to clinical relevance and infection rate in this population compared to healthy siblings, when applicable. The investigators will also restart vaccinations at earlier time points than previously studied, at 3 months post therapy, and will assess whether boosters or revaccination schedules are superior for regaining immunity against potentially serious infections in survivors.


Eligibility

Min Age: 2 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Vaccine for people with pediatric cancer. The study is currently recruiting participants at 1 location. People eligible for this study include aged 2 Years to 21 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVaccine

Patients will have lab evaluations for immune function at baseline, 3, 6, 9 and 24 months post completion of treatment. At 3 months off therapy, patients with abnormal vaccine antibody titers will be randomized to receive either single booster vaccines or to begin a full revaccination series that models post-hematopoietic stem cell transplant vaccination strategies.


Locations(1)

Levine Cancer Institute

Charlotte, North Carolina, United States

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NCT04948619


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