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

Primary Purpose

Influenza, Gammopathy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Fluzone

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Early Disease

Disease Requiring Anti-tumor therapy

Arm Description

Patients not requiring anti-tumor therapy

Patients that have disease requiring anti-tumor therapy at any time

Outcomes

Primary Outcome Measures

Rate of Disease Control

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

Secondary Outcome Measures

Influenza related morbidity rate

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

Serologic Protection Rate after initial vaccine

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

Serologic Protection Rate after initial vaccine

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

T cell response

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

T cell response

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

Full Information

NCT ID

NCT02267733

First Posted

October 13, 2014

Last Updated

August 24, 2016

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT02267733

Brief Title

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

Acronym

SHIVERING

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Gammopathy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early Disease

Arm Type

Experimental

Arm Description

Patients not requiring anti-tumor therapy

Arm Title

Disease Requiring Anti-tumor therapy

Arm Type

Experimental

Arm Description

Patients that have disease requiring anti-tumor therapy at any time

Intervention Type

Drug

Intervention Name(s)

Fluzone

Other Intervention Name(s)

Fluzone High Dose

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of Disease Control

Description

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

Time Frame

up to 10 months

Secondary Outcome Measure Information:

Title

Influenza related morbidity rate

Description

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

Time Frame

up to 10 months

Title

Serologic Protection Rate after initial vaccine

Description

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

Time Frame

30 days post vaccine

Title

Serologic Protection Rate after initial vaccine

Description

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

Time Frame

30 days post booster

Title

T cell response

Description

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

Time Frame

30 day post initial vaccine

Title

T cell response

Description

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

Time Frame

30 day post booster

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Branagan, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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