Title: Immune Function and Response to Vaccination Following Completion of Cancer Directed Systemic Therapy in Pediatric Patients With Cancer
Principal Investigator: Ashley Hinson, MD, Wake Forest University Health Sciences, Charlotte, North Carolina
Description: Researchers are conducting a prospective, randomized trial to evaluate immune dysfunction after the conclusion of cancer treatment in pediatric patients.
The trial is enrolling patients between 2 and 21 years of age who complete systemic cancer therapy at Levine Children’s Cancer & Blood Disorders in Charlotte, North Carolina.
The patients will be randomly assigned to 1 of 2 intervention arms. Patients in the first arm will undergo single booster vaccination, with non-live vaccine boosters at 3 and 12 months after treatment completion and live vaccines at 6 months. Patients in the second arm will undergo full revaccination, with non-live vaccines at their 3-month visit and live vaccines at their 6-month visit.
Patients will be receiving vaccines directed against Haemophilus influenza type B, tetanus, diphtheria, pertussis, polio, hepatitis B, Streptococcus pneumoniae, measles, mumps, rubella, and varicella.
All patients will have blood work to evaluate immune function at baseline, 3, 6, 12, and 24 months after the completion of their cancer treatment.
The primary outcome of the trial is to compare immune response after single booster vaccination and full revaccination at 24 months after cancer-directed systemic therapy. Secondary outcome measures include comparing immune abnormalities between the arms at 12 and 24 months and evaluating infection rates over 2 years in patients with residual immune dysfunction vs patients with recovered immune function.
To be eligible for this study, patients must be 2 to 21 years of age and have histological or cytological confirmation of any malignancy treated by the pediatric oncology team of Levine Children’s Hospital. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by Wake Forest University Health Sciences.
Clinicaltrials.gov. Immune function and response to vaccination after cancer therapy in pediatric patients. NCT04948619. Accessed May 23, 2022.