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

Yale University51 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Influenza Gammopathy

Interventions

FluzoneDRUG

Fluzone High-Dose will be administered with a planned booster at 30 days post initial administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale University

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Rate of Disease Control

Lack of disease progression requiring therapy as measured by International Myeloma Working Group criteria

Time frame: up to 10 months

Secondary Outcomes

Influenza related morbidity rate

Measure the rate of influenza related morbidity at the end of the flu season

Time frame: up to 10 months

Serologic Protection Rate after initial vaccine

Evaluate rates of serologic protection (defined as HAI titer \> 40) following initial vaccine dose

Time frame: 30 days post vaccine

Serologic Protection Rate after initial vaccine

Evaluate rates of serologic protection (defined as HAI titer \> 40) following booster vaccine dose

Time frame: 30 days post booster

T cell response

Measurement of CD4+/CD8+, NK cells and influenza-specific T cell

Time frame: 30 day post initial vaccine

T cell response

Measurement of CD4+/CD8+, NK cells and influenza-specific T cell

Time frame: 30 day post booster

Data from ClinicalTrials.gov

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