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

Last updated: January 20, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

2

Condition

Neuroblastoma

Retinoblastoma

Treatment

Vaccine

Clinical Study ID

NCT04948619
IRB00081757
00053603
LCI-PED-NOS-VACC-001
  • Ages 2-21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent, HIPAA authorization for release of personal healthinformation, and assent, when applicable from the subject, parent, or legalguardian.

  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 30days prior to date of enrollment

  4. Histological or cytological confirmation of any malignancy treated by the PediatricOncology team of Levine Children's Hospital

  5. History of any malignant diagnosis treated with at least one cycle of cancerdirected systemic therapy

  6. Must be no more than 60 days from last dose of cancer directed systemic therapy attime of enrollment

  7. As determined by the enrolling physician, ability of the subject andparent/caregiver to understand and comply with study procedures for the entirelength of the study

Exclusion

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 avaccine

  6. Documented current/active, severe infection, as determined by the investigator

Study Design

Total Participants: 64
Treatment Group(s): 1
Primary Treatment: Vaccine
Phase: 2
Study Start date:
August 08, 2022
Estimated Completion Date:
October 31, 2030

Study Description

This study is a prospective, randomized trial. The target population is all patients between the ages of 2 and 21 years of age who complete cancer directed systemic therapy for any malignant diagnosis at our center over a 2 to 3-year time frame. The study will be conducted in the various disease-specific off therapy and survivorship clinics of Levine Children's Cancer and Blood Disorders. Patients will have lab evaluations for immune function at baseline, 3, 6, 12, and 24 months from last dose of cancer directed systemic therapy. At 3 months from last dose of cancer directed systemic therapy, patients with abnormal vaccine antibody titers will be randomized to receive either single booster vaccines or to begin a full revaccination series that models post-hematopoietic stem cell transplant vaccination strategies. Vaccines given will be directed against Haemophilus influenza type B, tetanus, diphtheria, pertussis, polio, hepatitis B, Streptococcus pneumoniae, measles, mumps, rubella, and varicella. Live vaccines (measles, mumps, rubella, and varicella) will be given at 6 months from last dose of cancer directed systemic therapy. Repeat vaccine antibody titers will be assessed at follow up visits as above to determine if there are differences in immediate or maintained immunity based on vaccine strategy used. For subjects <18 years of age, we will present health questionnaires to their caregiver to answer at each of the time points. Subjects ≥18 years of age will complete their own health questionnaire. These questionnaires will assess frequency, type, and severity of viral and bacterial infections requiring antibiotics in study patients and their closest healthy sibling in age, when applicable.

Connect with a study center

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

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