Immune Function and Response to Vaccination After Cancer Therapy in Pediatric Patients (NCT04948619) | Clinical Trial Compass
RecruitingPhase 2
Immune Function and Response to Vaccination After Cancer Therapy in Pediatric Patients
United States64 participantsStarted 2022-08-08
Plain-language 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.
Who can participate
Age range
2 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vaccination comparison via objective lab measurements of vaccine titers
. 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
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