Gammopathy, Influenza
Conditions
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.
Interventions
DRUGFluzone
Fluzone High-Dose will be administered with a planned booster at 30 days post initial administration
Sponsors
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Disease Control | up to 10 months | Lack of disease progression requiring therapy as measured by International Myeloma Working Group criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 vaccine | Evaluate rates of serologic protection (defined as HAI titer \> 40) following initial vaccine dose |
| T cell response | 30 day post initial vaccine | Measurement of CD4+/CD8+, NK cells and influenza-specific T cell |
Countries
United States
Outcome results
None listed