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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

Phase 2
18 Years
Not Enrolling

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Trial Information

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

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


United States: Federal Government

Study ID:




Start Date:

August 2004

Completion Date:

April 2005

Related Keywords:

  • Influenza
  • influenza vaccine, baculovirus, immunogenicity, lymphoma
  • Influenza, Human
  • Lymphoma
  • Lymphoma, B-Cell



University of Texas MD Anderson Cancer Center Houston, Texas  77030