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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 - Version 4

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 - Version 4

Influenza is a common respiratory infection caused by viruses. Standard influenza vaccines
may not be as effective at protecting cancer patients as the general population from getting
influenza. New technology has been developed that allows stronger (and hopefully more
effective) influenza vaccines to be developed. This research study will test an experimental
influenza vaccine.

If you agree to take part in this study, you will be randomly assigned (as in the toss of a
coin) to receive either standard inactivated influenza vaccine or one of three doses of the
experimental vaccine. You will have an equal chance of being assigned to any of the four
treatment groups. Neither your physician, the study doctor, or you will know which vaccine
or dose you received. In case of an emergency, the study doctor can find out which vaccine
and dose you received.

Before the injection is given, a blood test will be taken to measure your antibodies
(substances that fight infection). About two teaspoons of blood will be taken for this
blood test. The vaccine will be given as a one time injection in the arm. After you are
given the injection, you will be observed for 20 minutes in the clinic before you are sent
home. Everyone taking part in this study will be asked to keep a symptom diary and
temperature log for 1 week after the injection. After 7 days, you will return for review of
the diary and any symptoms you may have had.

At 4 and 8 weeks after the influenza vaccine is given, most patients will have a blood test
to learn the amount of immunity against the influenza virus they have developed. About
two teaspoons of blood will be required for this test. A few patients may not be eligible
for the eight week blood collection and will be instructed by the study nurse about future
visits to UTMDACC. Six months after you have received the vaccine, you will be contacted by
one of the study personnel to ask you if you had any serious side effects that might be from
the study vaccine. Once you have received this follow-up telephone call, your
participation in this study will be completed.

This is an investigational study. The standard vaccine used in this study is FDA approved
and commercially available. The experimental vaccine is authorized for use in research only.
About 100 patients will take part in this study. All will be enrolled at UTMDACC.

This protocol is partially funded by a research contract from the National Institutes of
Health (NIH) to Baylor College of Medicine.

Inclusion Criteria:

1. Patients with non-Hodgkin's B-cell lymphoma (NHL) including follicular, large cell
and Mantle cell lymphoma will be included.

2. Patients in complete clinical remission and determined to have no evidence of active
disease (NED).

3. Patients greater than or equal to 18 years of age who have given informed consent and
signed the IRB approved informed consent.

4. 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 of less than or equal to 2.

5. 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.

6. Patients with a non-metastatic secondary solid tumor or malignancies not currently (<
3 months) being treated will be included.

Exclusion Criteria:

1. Patients with Hodgkin's disease, and T-cell lymphoma.

2. Patients undergoing antineoplastic therapy.

3. Patients who have received chemotherapy within the past 3 months.

4. Individuals who were given rituximab (ibritumomab tiuxetan) in < 6 months.

5. Patients receiving systemic corticosteroids and/or high-dose inhaled steroids (>800
mcg per day of beclomethasone dipropionate or equivalent).

6. Splenectomized individuals will not be included.

7. Known allergy to eggs or other components of vaccine (e.g., thimerosal).

8. 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).

9. 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.

10. Previous exposure to parenteral immunoglobulins or other blood product within 6
months prior to enrollment into the study.

11. Subject is enrolled in a conflicting clinical trial.

12. Use of experimental vaccines or medications within one month of study entry.

13. Any acute or chronic condition which in the opinion of the investigator would render
vaccination unsafe or interfere with the evaluation of response.

14. 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 Immunodeficiency Virus.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

Immunogenic response across patients administered either licensed trivalent inactivated influenza vaccine (TIV) or one of three doses (15, 45 or 135 μg) of trivalent recombinant baculovirus expressed hemagglutinin vaccines.

Outcome Time Frame:

3 Years

Safety Issue:


Principal Investigator

Amar Safdar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2004

Completion Date:

February 2007

Related Keywords:

  • Lymphoma
  • Non-Hodgkin's Lymphoma
  • Influenza Vaccination
  • Trivalent Baculovirus-Expressed Influenza HA vaccine
  • Antineoplastic Therapy
  • Influenza, Human
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



U.T.M.D. Anderson Cancer Center Houston, Texas  77030