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

NCT04948619 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IRB0008175700053603LCI-PED-NOS-VACC-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Cancer

Keywords

Pediatric Oncology; Vaccine

Outcome Measures

Primary Outcomes (1)

• Vaccination comparison via objective lab measurements of vaccine titers

  To compare single booster vaccination (Arm A) to full revaccination (Arm B) in terms of immune response at 24 months post cancer directed systemic therapy in pediatric subjects who have received cancer directed systemic therapy for any malignancy.

  2 years

Secondary Outcomes (5)

• Vaccine comparison at 12 & 24 months

  Up to 2 years

• Infection Rates

  Up to 2 years

• Healthy Sibling comparison

  Up to 2 years

• Immune Abnormalities - Malignancy

  Up to 2 years

• Immune Abnormalities - Primary Vaccination Status

  Up to 2 years

Other Outcomes (1)

• Safety - Potential Side Effects

  Up to 5.5 years

Study Arms (2)

Arm A - Single booster vaccines

OTHER

Those subjects randomized to Arm A, single dose vaccine boosters, will receive non live vaccine boosters at the 3 month visit. Boosters for live vaccines will be given at the 6 month visit. Boosters will only be given as applicable for low titers tested at the baseline assessment visit. Subjects who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine.

Biological: Vaccine

Arm B - Staged revaccination series

OTHER

Those subjects randomized to Arm B, the full revaccination series, will receive applicable vaccines when titers are low (below normal range) at baseline. When indicated, non-live vaccines will be given at the 3, 6, and 9 month visits, live vaccines will be given at the 6 and 9 month visit. Subjects who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine.

Biological: Vaccine

Interventions

Vaccine BIOLOGICAL

Patients will have lab evaluations for immune function at baseline, 3, 6, 9 and 24 months post completion of treatment. At 3 months off 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.

Arm A - Single booster vaccines; Arm B - Staged revaccination series

Eligibility Criteria

• Age: 2 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 30 days prior to date of enrollment
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Vaccines

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Ashley Hinson, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sceria Jenkins, RN

CONTACT

980-442-2323; Sceria.Jenkins@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: July 2, 2021
• Study Start: August 8, 2022
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)