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

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

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

Study Overview

• Status: Completed
• Conditions: Influenza; Gammopathy
• Intervention / Treatment: Drug: Fluzone

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Andrew Branagan, MD, Yale University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 13, 2014
• First Submitted That Met QC Criteria: October 13, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Estimate): August 25, 2016
• Last Update Submitted That Met QC Criteria: August 24, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 1406014244