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The purpose of this research is to compare reactions and antibody responses following receipt of different doses of the experimental influenza vaccine or standard influenza vaccine.
Influenza is a common respiratory infection caused by viruses. Epidemics of influenza occur each winter and are responsible for more than 20,000 deaths each year in the United States. Most of these deaths occur among elderly persons and among people of all ages who suffer from a chronic disease. Standard influenza vaccines may not be as effective at protecting cancer patients as the general population from getting influenza. This research study will test an experimental influenza vaccine consisting of the important flu virus protein that stimulates protection. It is produced by genetic techniques in cultured cells and allows higher doses of the protein to be used. Influenza vaccines made this way have been given to humans in the past and the vaccine was well tolerated. It is expected that higher doses of this vaccine can be given with minimal reactions, as well as whether such a vaccine stimulates higher levels of infection-fighting proteins (or antibodies) in the blood than standard doses of the licensed influenza vaccine. This study will evaluate the reactogenicity and immunogenicity of a recombiant influenza vaccine in non-Hodgkin's B cell lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm D | Experimental | 25 subjects receive Recombinant rHA0 vaccine at 135 mcg per rHA0, via IM injection on Day 0 |
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| Arm C | Experimental | 25 subjects receive Recombinant rHA0 vaccine at 45 mcg per rHA0, via IM injection on Day 0 |
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| Arm B | Experimental | 25 subjects receive Recombinant rHA0 vaccine at 15 mcg per rHA0, via IM injection on Day 0 |
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| Arm A | Active Comparator | 25 subjects receive Standard TIV at 15 mcg HA per virus, in a total volume of 0.5 mL, by deep intramuscular (IM) injection on Day 0 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent inactivated influenza vaccine | Biological | Standard Trivalent inactivated influenza vaccine, licensed. Arm A receives standard dose of 15 mcg IM on day 0. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Trivalent Baculovirus-expressed Influenza HA vaccine | Biological | Trivalent Baculovirus-expressed influenza HA vaccine (Recombinant rHA0): Arms B, C and D receive 15 mcg, 45 mcg or 135 mcg IM dose on Day 0. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C510901 | trivalent baculovirus-expressed influenza-virus hemagglutinin vaccine |
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