Status:
COMPLETED
Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 de...
Eligibility Criteria
Inclusion
- Patients with non-Hodgkin's B-cell lymphoma (NHL) including follicular, large cell and Mantle cell lymphoma will be included.
- Patients in complete clinical remission and determined to have no evidence of active disease (NED).
- Ambulatory, medically stable persons; community dwelling; able to give informed consent and available for all study visits; able to understand and comply with planned study procedures; ECOG performance status less than or equal to 2.
- Medically stable subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, but their symptoms/signs are controlled with medical therapy.
- Patients with a non-metastatic secondary solid tumor or malignancies not currently (\< 3 months) being treated will be included.
- Patients greater than or equal to 18 years of age who have given informed consent and signed the IRB approved informed consent.
Exclusion
- Patients with Hodgkin's disease, and T-cell lymphoma.
- Patients undergoing antineoplastic therapy.
- Patients who have received chemotherapy within the past 3 months.
- Individuals who were given rituximab (ibritumomab tiuxetan) in \< 6 months.
- Patients receiving systemic corticosteroids and/or high-dose inhaled steroids (\>800 mcg per day of beclomethasone dipropionate or equivalent).
- Splenectomized individuals will not be included.
- Known allergy to eggs or other components of vaccine (e.g., thimerosal).
- Acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses (including but not limited to the following: acute febrile illness, known chronic liver disease; significant renal disease; oxygen-dependent chronic lung disease, New York Heart Association Functional Class III or IV dyspnea; unstable or progressive neurologic disorder; insulin-dependent diabetes mellitus).
- Concomitant use of investigational vaccines and/or other medications within 4 weeks prior to study entry, or expected use of experimental or licensed vaccines or blood/blood products prior to study completion.
- Previous exposure to parenteral immunoglobulins or other blood product within 6 months prior to enrollment into the study.
- Subject is enrolled in a conflicting clinical trial.
- Use of experimental vaccines or medications within one month of study entry.
- Any acute or chronic condition which in the opinion of the investigator would render vaccination unsafe or interfere with the evaluation of response.
- Patients with a known history or risk factors (IV drug abuse or casual sex within the past year) of Hepatitis B, Hepatitis C, or Human Immunodeficeincy Virus.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00307177
Start Date
August 1 2004
End Date
April 1 2005
Last Update
December 5 2014
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030