NCT04948619RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 15 Jun 2021
- Start date
- 8 Aug 2022
- Primary completion date
- Oct 2030
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Childhood cancers
- NCT number
- NCT04948619
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 64
- From 8 Aug 2022 to the primary completion date, Oct 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Malignant disease treated with observation, surgery, or radiotherapy alone
- Subjects with normal baseline titers for all investigated vaccines
- Documented previous severe allergic reaction to any vaccine or component of a vaccine
Other illness
- Documented current/active, severe infection, as determined by the investigator
Other
- Known coexisting immunodeficiency
- Known pregnancy
Who the study is looking for
- 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
Age in the registry: 2 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.