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A Pilot Study utilizing high dose trivalent influenza vaccine dose in a booster dosing schedule for patients with monoclonal gammopathies stratified by disease status
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Disease | Experimental | Patients not requiring anti-tumor therapy |
|
| Disease Requiring Anti-tumor therapy | Experimental | Patients that have disease requiring anti-tumor therapy at any time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzone | Drug | Fluzone High-Dose will be administered with a planned booster at 30 days post initial administration |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Branagan, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06519 | United States |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| C000618615 | Fluzone High-Dose |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| 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 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |