Actively Recruiting

Phase 2
Age: 2Years - 21Years
All Genders
NCT04948619

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

Led by Wake Forest University Health Sciences · Updated on 2026-01-22

64

Participants Needed

1

Research Sites

425 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

A

Atrium Health Levine Cancer Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent, HIPAA authorization, and assent when applicable
  • Age 2 years or older and less than 22 years at consent
  • Lansky/Karnofsky Performance Status over 50 (ECOG less than 2) within 30 days before enrollment
  • Confirmed diagnosis of any malignancy treated by Levine Children's Hospital Pediatric Oncology team
  • History of malignant diagnosis treated with at least one cycle of cancer-directed systemic therapy
  • No more than 60 days from last cancer therapy dose at enrollment
  • Ability of participant and caregiver to understand and comply with study procedures for entire study duration
Not Eligible

You will not qualify if you...

  • Malignancy treated with observation, surgery, or radiotherapy alone
  • Known coexisting immunodeficiency
  • Normal baseline antibody titers for all studied vaccines
  • Known pregnancy
  • Previous severe allergic reaction to any vaccine or vaccine component
  • Current active severe infection as determined by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Levine Cancer Institute

Charlotte, North Carolina, United States, 28204

Actively Recruiting

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Research Team

S

Sceria Jenkins, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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