Response to Influenza Vaccination in Pediatric Oncology Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Response to Influenza Vaccination in Pediatric Oncology Patients

Conditions
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Hematologic Malignancy, Pediatric Cancer, Transplant-Related Cancer

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric Influenza Vaccine Recipients<br>Pediatric patients eligible to receive seasonal influenza vaccine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of evaluable participants. | 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. | 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. | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza infection