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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 24, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how cancer treatment affects the immune system in children and young adults who have survived cancer. Researchers want to understand why these survivors are more likely to get infections and how quickly they can regain their immunity after finishing therapy. They will start giving vaccinations earlier than usual—just three months after treatment ends—and will compare different vaccination schedules to see which one works better to help these patients develop strong protection against serious infections.

To participate in the study, candidates must be between 2 and 21 years old, have a confirmed history of cancer treated with specific therapies, and be within 60 days of completing their last treatment. The study requires consent from parents or guardians, and participants will be monitored closely throughout the trial. This is a great opportunity for pediatric cancer survivors to help researchers learn more about improving health after cancer treatment and potentially receive important vaccinations sooner.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.
• • 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 30 days prior to date of enrollment
• • 4. Histological or cytological confirmation of any malignancy treated by the Pediatric Oncology team of Levine Children's Hospital
• • 5. History of any malignant diagnosis treated with at least one cycle of cancer directed systemic therapy
• • 6. Must be no more than 60 days from last dose of cancer directed systemic therapy at time of enrollment
• • 7. 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
• 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 a vaccine
• • 6. Documented current/active, severe infection, as determined by the investigator