High-Dose Trivalent Influenza Vaccine in Inducing Immune Response Patients With Central Nervous System Tumors

Study Overview
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Brief Summary
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This pilot clinical trial studies high-dose trivalent influenza vaccine in inducing immune response patients with central nervous system tumors. Studying samples of blood in the laboratory from patients receiving trivalent influenza vaccine may help doctors learn more about the effects of trivalent influenza vaccine on cells. It may also help doctors understand how well patients respond to treatment.

Detailed Description
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PRIMARY OBJECTIVES: I. To estimate the immunogenicity of high-dose influenza vaccination in patients with central nervous system tumors. SECONDARY OBJECTIVES: I. To assess the geometric mean titer (GMT) in patients after administration of high-dose influenza vaccination compared to previously determined geometric mean titer (GMT) among 38 patients receiving the standard yearly influenza vaccination. II. To assess the seroconversion rates (i.e. four-fold rise in titer) compared to previously determined seroconversion following administration of the standard yearly influenza vaccination. III. To assess the seroprotection rates (i.e. post-vaccination titer >= 1:40) compared to previously determined seroconversion and seroprotection following administration of the standard yearly influenza vaccination. TERTIARY OBJECTIVES: I. To assess the relationship between serologic markers of immune function and response to high-dose vaccination. OUTLINE: Patients receive trivalent influenza vaccine on day 1. After completion of study, patients are followed up at 28 days and/or 3 months.

Official Title
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A Pilot Single Arm Study of High-Dose Influenza Vaccine Immunogenicity in Patients With Central Nervous System Tumors

Conditions
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Central Nervous System Neoplasm

Intervention / Treatment
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* Biological: trivalent influenza vaccine
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have a clinical diagnosis of a primary central nervous system tumor Patients must be eligible to receive the influenza vaccine Patients must be willing to receive the Fluzone® high-dose seasonal influenza vaccine Patients must be willing and able to sign an Institutional Review Board (IRB)-approved written informed consent document Exclusion Criteria: Patients unable to receive the high-dose influenza vaccine due to history of allergy to egg proteins, allergy to influenza vaccine component, acute febrile illness at the time of proposed vaccine administration, history of clinically or virologically confirmed influenza infection in the previous 6 months, contraindication to intramuscular injections, Guillain-Barré syndrome, or other contraindication to the vaccine Patients who have received the 2013-2014 annual influenza vaccine prior to being considered for enrollment on this study

Ages Eligible for Study
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Minimum 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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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Basic science (trivalent influenza vaccine)<br>Patients receive trivalent influenza vaccine on day 1. | Biological: trivalent influenza vaccine<br> <br> * Other names: Influenza Vaccine;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimation of geometric mean titer (GMT) seroconversion, defined as the percentage of patients with at least a four-fold increase in hemagglutinin inhibition (HI) antibodies |  | Baseline | 
| Estimation of GMT seroconversion, defined as the percentage of patients with at least a four-fold increase in HI antibodies |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GMT | Continuous values will be analyzed using Wilcoxon rank sum tests to compare high dose influenza vaccine to previously reported data on immunogenicity to the standard trivalent inactivated vaccine. | Up to 3 months | 
| Seroconversion | Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate. | Up to 3 months | 
| Seroprotection rate, defined as the percentage of patients with a serum HI antibody of at least 1:40 | Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate. | Up to 3 months |