About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
All participants who meet eligible criteria and consent to enrollment on the study.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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
Sponsors and contacts
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