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

Phase 1

Completed

• Conditions: Influenza; Gammopathy
• Interventions: Drug: Fluzone

• Registration Number: NCT02267733
• Lead Sponsor: Yale University

Brief Summary

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

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-13
• Study First Submitted QC: 2014-10-13
• Study First Posted: 2014-10-17
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Disease Requiring Anti-tumor therapy	Fluzone	Patients that have disease requiring anti-tumor therapy at any time
Early Disease	Fluzone	Patients not requiring anti-tumor therapy

Primary Outcome Measures

Name	Time	Method
Rate of Disease Control	up to 10 months	Lack of disease progression requiring therapy as measured by International Myeloma Working Group criteria

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States