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

NCT ID: NCT02267733

Last Updated: 2016-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-12-31

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.

Conditions

Influenza; Gammopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Early Disease

Patients not requiring anti-tumor therapy

Group Type: EXPERIMENTAL

Fluzone

Intervention Type: DRUG

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

Disease Requiring Anti-tumor therapy

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

Group Type: EXPERIMENTAL

Fluzone

Intervention Type: DRUG

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

Interventions

Fluzone

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

Intervention Type: DRUG

Other Intervention Names

Fluzone High Dose

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Branagan, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1406014244

Identifier Type: -

Identifier Source: org_study_id