Who is eligible for clinical trial NCT04948619?

Participants must meet protocol criteria for Pediatric Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04948619 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-21

Immune Function and Response to Vaccination After Cancer Therapy in Pediatric Patients (NCT04948619)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Wake Forest University Health Sciences

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (7 items).

Location: Levine Cancer Institute — Charlotte, North Carolina

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.
Age greater than or equal to 2 years and less than 22 years at the time of consent
Lansky/Karnofsky Performance Status of greater than 50 (ECOG less than 2) within 60 days prior to date of enrollment/randomization
Histological or cytological confirmation of any malignancy treated by the Pediatric Oncology team of Levine Children's Hospital
History of any malignant diagnosis treated with at least one cycle of cancer directed systemic therapy
Must be no more than 60 days from last dose of cancer directed systemic therapy at time of enrollment/randomization
As determined by the enrolling physician, ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Malignant disease treated with observation, surgery, or radiotherapy alone
Known coexisting immunodeficiency
Subjects with normal baseline titers for all investigated vaccines
Known pregnancy
Documented previous severe allergic reaction to any vaccine or component of a vaccine
Documented current/active, severe infection, as determined by the investigator

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Levine Cancer Institute — Charlotte, North Carolina

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗