Clinical trial NCT05384288: Response to Influenza Vaccination in Pediatric Oncology Patients
Official title: Response to Influenza Vaccination in Pediatric Oncology Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematologic Malignancy
Pediatric Cancer
Transplant-Related Cancer
Keywords: Influenza infection
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 113
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants who meet eligible criteria and consent to enrollment on the study.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of evaluable participants.
timeFrame: 3 years
measure: Proportion of participants with immunogenicity 3 to 5 weeks following vaccination.
timeFrame: 3 years
Secondary outcomes:
measure: Proportion of participants with an immune response 1 to 2 weeks following vaccination.
timeFrame: 3 years
measure: Proportion of participants with durability of immunogenicity at 6 months and 1 year post-vaccination.
timeFrame: 3 years
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Ramilo Octavio, MD
role: PRINCIPAL_INVESTIGATOR
References: