Influenza Clinical Trial
Official title:
Evaluation of the Reactogenicity and Immunogenicity of Different Doses of Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma: A Phase II, Double-Blind Pilot Study
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | April 2005 |
Est. primary completion date | April 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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