Evaluating immune response to vaccines in pediatric cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates immune dysfunction in pediatric cancer survivors after completing cancer-directed therapy. It focuses on assessing infection rates and immune responses by comparing these survivors to healthy siblings. The trial involves a randomized approach where patients will receive either booster vaccines or a full revaccination series starting three months post-therapy. Immune function will be evaluated at multiple time points to determine the effectiveness of the vaccination strategies employed.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.
2. Age greater than or equal to 2 years and less than 22 years at the time of consent
3. Lansky/Karnofsky Performance Status of greater than 50 (ECOG less than 2) within 60 days prior to date of enrollment/randomization
4. Histological or cytological confirmation of any malignancy treated by the Pediatric Oncology team of Levine Children's Hospital
5. History of any malignant diagnosis treated with at least one cycle of cancer directed systemic therapy
6. Must be no more than 60 days from last dose of cancer directed systemic therapy at time of enrollment/randomization
7. 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:

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

Where it's running

• Levine Cancer Institute
  Charlotte, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Ashley Hinson, MD — Wake Forest University Health Sciences
• Study coordinator: Sceria Jenkins, RN
• Email: Sceria.Jenkins@advocatehealth.org
• Phone: 980-442-2323

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• FaceSay: a computer program to help kids recognize facial expressions and improve social interactions

  A computer-based FaceSay program is tested to see if it helps survivors of pediatric brain tumors who have social difficulties see facial expressions better and relate more comfortably with peers.

  Recruiting Children's Hospital of Philadelphia · Philadelphia, Pennsylvania · NCT07923370

• Access to Innovative Cancer Treatments for Children and Young People in Belgium

  This observational study collects safety and effectiveness data on off‑label and compassionate cancer medicines used in kids and young adults up to age 25 in Belgium.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Antwerp and 5 other locations · NCT07727694

• BCB-276 CAR T therapy for DIPG in children and young adults

  This study tests BCB-276, a patient's own CAR T cells against DIPG, after standard radiation, to see if it is safe and can help extend survival.

  Recruiting at 3 sites Phase 2 BrainChild Bio, Inc · Los Angeles, California and 5 other locations · NCT07680439

• CAYA cancer patients in LMICs: a forward-looking observation of care and outcomes

  This study follows children, teens, and young adults with cancer in low- and middle-income countries to see how routine care affects treatment, access, and outcomes over time.

  Recruiting Resonance, Inc. · Yerevan and 5 other locations · NCT07632014

• Virtual reality headsets to reduce anxiety and fear during intrathecal chemotherapy in children

  This project will try virtual reality headsets with children aged 4–10 who are receiving intrathecal chemotherapy to see if they reduce anxiety, fear, and changes in vital signs.

  Recruiting TC Erciyes University · Kayseri · NCT07537062

• Laser thermal therapy for young people with low-grade glioma

  This research will test whether laser interstitial thermal therapy (LITT) can stop or slow recurrent or progressive low-grade gliomas in children, adolescents, and young adults.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07506239

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.