Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
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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