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

Description

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

Pediatric Cancer

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Study Overview

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Study Details

Study overview

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.

Immune Function and Response to Vaccination Following Completion of Cancer Directed Systemic Therapy in Pediatric Patients With Cancer

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

Condition
Pediatric Cancer
Intervention / Treatment

-

Contacts and Locations

Charlotte

Levine Cancer Institute, Charlotte, North Carolina, United States, 28204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 30 days prior to date of enrollment
  • 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
  • 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
  • 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

Ages Eligible for Study

2 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Ashley Hinson, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

2025-01