RECRUITING

Response to Influenza Vaccination in Pediatric Oncology Patients

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

Influenza infection occurring during oncologic treatment or following hematopoietic cell transplantation (HCT) is associated with increased risk of morbidity in the form of lower respiratory tract infection (LRTI) and mortality relative to otherwise healthy patients. The study participants have been diagnosed with a hematological malignancy and are eligible to receive the current seasonal influenza (Flu) vaccine. Primary Objective * To determine the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients. * To describe the immunogenicity, as measured by the development of cell- and/or antibody-mediated influenza specific responses 3 to 5 weeks following vaccination, in a cohort of pediatric leukemia patients. Secondary Objectives * To describe whether an immune response, as measured by development of cell- and/or antibody-mediated influenza specific responses, is detectable 1-2 weeks following vaccination in a cohort of pediatric leukemia patients. * To describe the durability of immunogenicity by measuring cell - and antibody- mediated influenza specific responses at 6 months and 1 year following vaccination in a cohort of pediatric leukemia patients. Exploratory Objectives * To estimate the clinical effectiveness of influenza vaccine in this cohort by monitoring for the development of clinical diagnosis of influenza in the cohort of enrolled pediatric oncology patients. * To correlate results of immune cell frequency in blood, as measured by complete blood count with differential, with development of an immune response to IIV.

Official Title

Response to Influenza Vaccination in Pediatric Oncology Patients

Quick Facts

Study Start:2022-10-07
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05384288

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:Not specified to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient ≤ 18 years old at the time of consent receiving care at St. Jude Children's Research Hospital
  2. * Diagnosed with a hematological malignancy
  3. * Eligible to receive the current seasonal influenza vaccine
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Ramilo Octavio, MD
CONTACT
866-278-5833
referralinfo@stjude.org

Principal Investigator

Ramilo Octavio, MD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Ramilo Octavio, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

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 Date2022-10-07
Study Completion Date2027-12

Study Record Updates

Study Start Date2022-10-07
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Influenza infection

Additional Relevant MeSH Terms

  • Hematologic Malignancy
  • Pediatric Cancer
  • Transplant-Related Cancer