Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing In Gammopathy Patients

Study Overview
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Brief Summary
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A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status

Detailed Description
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In this study, we will administer Fluzone® High-Dose vaccine with a planned booster to patients with monoclonal gammopathies (stratified by requirement for therapy) irrespective of age. All patients will receive an initial vaccine followed by a booster vaccine 30 days (+/- 7 days) later and will then be followed for outcomes until the end of flu season.

Official Title
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Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients (SHIVERING Trial)

Conditions
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Influenza, Gammopathy

Intervention / Treatment
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* Drug: Fluzone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Understand and voluntarily sign an informed consent document Age >= 18 years at the time of signing the informed consent form Diagnosis of any monoclonal gammopathy; Monoclonal Gammopathy of Undetermined Significance (MGUS), asymptomatic/ active multiple myeloma, asymptomatic / active Waldenstrom Macroglobulinemia (WM) Exclusion Criteria: An serious egg allergy or prior serious adverse reaction to an influenza vaccine Use of any other influenza vaccine for the 2014 to 2015 flu season Women who are pregnant or plan to become pregnant in the study period

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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Disease<br>Patients not requiring anti-tumor therapy | Drug: Fluzone<br>* Fluzone High-Dose will be administered with a planned booster at 30 days post initial administration<br>* Other names: Fluzone High Dose;|
| Experimental: Disease Requiring Anti-tumor therapy<br>Patients that have disease requiring anti-tumor therapy at any time | Drug: Fluzone<br>* Fluzone High-Dose will be administered with a planned booster at 30 days post initial administration<br>* Other names: Fluzone High Dose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Disease Control | Lack of disease progression requiring therapy as measured by International Myeloma Working Group criteria | up to 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza related morbidity rate | Measure the rate of influenza related morbidity at the end of the flu season | up to 10 months | 
| Serologic Protection Rate after initial vaccine | Evaluate rates of serologic protection (defined as HAI titer > 40) following initial vaccine dose | 30 days post vaccine | 
| Serologic Protection Rate after initial vaccine | Evaluate rates of serologic protection (defined as HAI titer > 40) following booster vaccine dose | 30 days post booster | 
| T cell response | Measurement of CD4+/CD8+, NK cells and influenza-specific T cell | 30 day post initial vaccine | 
| T cell response | Measurement of CD4+/CD8+, NK cells and influenza-specific T cell | 30 day post booster |