Response to Influenza Vaccination in Pediatric Oncology Patients

St. Jude Children's Research Hospital

Status

Enrolling

Conditions

Hematologic Malignancy

Transplant-Related Cancer

Pediatric Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT05384288

RIVIPOP

NCI-2022-05167 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is a prospective, 2-stage, non-therapeutic study to characterize the immunogenicity of influenza vaccination among pediatric oncology patients at St. Jude. The first stage of the study will consist of a feasibility phase to assess the feasibility of opening a longitudinal prospective study of IIV immunogenicity in pediatric leukemia patients. The second stage will assess the immunogenicity of IIV among pediatric leukemia patients in a larger samples size. The investigator will collect about one teaspoon of blood from the study participant up to 6 times over a year for a total of 6 teaspoons a year. The investigator will also collect some information about the study participant's underlying condition, flu testing and overall health from the medical record during this time.

Enrollment

150 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient ≤ 18 years old at the time of consent receiving care at St. Jude Children's Research Hospital
Diagnosed with a hematological malignancy
Eligible to receive the current seasonal influenza vaccine

Exclusion criteria

• Previously received at least one dose of the current seasonal influenza vaccine.