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RECRUITING
NCT04948619
PHASE2

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

Sponsor: Wake Forest University Health Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 21 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2022-08-08

Completion Date

2030-10

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

BIOLOGICAL

Vaccine

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.

Locations (1)

Levine Cancer Institute

Charlotte, North Carolina, United States