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

Yale University

Status and phase: Completed; Phase 1

Conditions: Gammopathy; Influenza

Treatments: Drug: Fluzone

Study type: Interventional

Funder types: Other

Identifiers

NCT02267733

1406014244

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Early Disease

Experimental group

Description:

Patients not requiring anti-tumor therapy

Treatment:

Drug: Fluzone

Disease Requiring Anti-tumor therapy

Experimental group

Description:

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

Treatment:

Drug: Fluzone