Response to Influenza Vaccination in Pediatric Oncology Patients

June 11, 2026 updated by: St. Jude Children's Research Hospital

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Ramilo Octavio, MD
Phone Number: 866-278-5833
Email: referralinfo@stjude.org

Study Locations

United States
- Tennessee
  - Memphis, Tennessee, United States, 38105
    - Recruiting
    - St. Jude Children's Research Hospital
    - Contact:
      
      Ravilo Octavio, MD
      
      Phone Number: 866-278-5833
      
      Email: referralinfo@stjude.org
    - Principal Investigator:
      
      Ramilo Octavio, MD

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.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

All participants who meet eligible criteria and consent to enrollment on the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Pediatric Influenza Vaccine Recipients Pediatric patients eligible to receive seasonal influenza vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of evaluable participants. Time Frame: 3 years	Feasibility is estimated as the proportion of evaluable patients who provide a baseline and Day +35 sample. A 95% confidence interval will be provided.	3 years
Proportion of participants with immunogenicity 3 to 5 weeks following vaccination. Time Frame: 3 years	Immunogenecity will be measured by the development of cell- and antibody-mediated influenza specific responses 3 to 5 weeks following vaccination. Immunogenicity is estimated as the proportion of evaluable patients whose cell- (as measured by development of any detectable specific T cell responses) and antibody-mediated influenza specific responses (as measured by detectable post vaccination antibody titers) 3 to 5 weeks following vaccination. 95% confidence intervals will be provided.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with an immune response 1 to 2 weeks following vaccination. Time Frame: 3 years	The proportion of patients who have detectable cell- and antibody-mediated influenza specific responses 1-2 weeks following vaccination will be estimated along with a 95% confidence interval.	3 years
Proportion of participants with durability of immunogenicity at 6 months and 1 year post-vaccination. Time Frame: 3 years	The proportion of patients who still have detectable cell- and antibody-mediated influenza specific responses 6 months and 1 year following vaccination will be estimated, respectively. 95% confidence intervals will be provided	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

Principal Investigator: Ramilo Octavio, MD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

October 7, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria