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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-21
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Malignant disease treated with observation, surgery, or radiotherapy alone

Known coexisting immunodeficiency

Subjects with normal baseline titers for all investigated vaccines

Known pregnancy

Trial design

Treatments tested in this trial

  • Vaccine

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Wake Forest University Health Sciences

Lead sponsor

Atrium Health Levine Cancer Institute

Collaborator