RECRUITING

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

Conditions

Pediatric Cancer Pediatric Oncology Vaccine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-08-08

Study Completion:2025-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04948619

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Sceria Jenkins, RN

CONTACT

980-442-2323

sceria.jenkins@atriumhealth.org

Principal Investigator

Ashley Hinson, MD

PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Study Locations (Sites)

Levine Cancer Institute

Charlotte, North Carolina, 28204

United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

Ashley Hinson, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-08

Study Completion Date2025-01

Study Record Updates

Study Start Date2022-08-08

Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

Pediatric Oncology
Vaccine

Additional Relevant MeSH Terms

Pediatric Cancer