Influenza Vaccination in Patients Receiving Antineoplastic Therapy for Non-Hodgkin's Lymphoma

NCT ID: NCT00307710

Last Updated: 2012-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2007-02-28

Brief Summary

Primary Objective:

To assess the trend in 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. Immunogenic response is defined as a 4-fold or greater increase in serum antibody.

Secondary Objective:

To determine the safety and tolerability of 3 doses (15 μg HA per virus, 45 μg HA per virus, and 135 μg HA per virus) of recombinant baculovirus-expressed HA vaccine in patients with non-Hodgkin's B-cell lymphoma.

Detailed Description

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.

Conditions

Lymphoma

Keywords

Non-Hodgkin's Lymphoma; Influenza Vaccination; Trivalent Baculovirus-Expressed Influenza HA vaccine; Antineoplastic Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A: Trivalent Subvirion Vaccine

Group A: Trivalent subvirion vaccine - standard inactivated influenza vaccine by intramuscular injection.

Group Type: EXPERIMENTAL

Trivalent Baculovirus-expressed Influenza HA vaccine

Intervention Type: BIOLOGICAL

Receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine, vaccine dose 15, 45 or 135 μg HA per virus, intramuscular injection.

B: Vaccine 15 μg

Group B: Trivalent rHA0 vaccine 15 μg per rHA0 (total 45 μg rHA0)

Group Type: EXPERIMENTAL

Trivalent Baculovirus-expressed Influenza HA vaccine

Intervention Type: BIOLOGICAL

Receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine, vaccine dose 15, 45 or 135 μg HA per virus, intramuscular injection.

C: Vaccine 45 μg

Group C: Trivalent rHA0 vaccine 45 μg per rHA0 (total 135 μg rHA0)

Group Type: EXPERIMENTAL

Trivalent Baculovirus-expressed Influenza HA vaccine

Intervention Type: BIOLOGICAL

Receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine, vaccine dose 15, 45 or 135 μg HA per virus, intramuscular injection.

D: Vaccine 135 μg

Group D: Trivalent rHA0 vaccine 135 μg per rHA0 (total 405 μg rHA0)

Group Type: EXPERIMENTAL

Trivalent Baculovirus-expressed Influenza HA vaccine

Intervention Type: BIOLOGICAL

Receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine, vaccine dose 15, 45 or 135 μg HA per virus, intramuscular injection.

Interventions

Trivalent Baculovirus-expressed Influenza HA vaccine

Receive either standard inactivated influenza vaccine or one of three doses of the experimental vaccine, vaccine dose 15, 45 or 135 μg HA per virus, intramuscular injection.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amar Safdar, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

U.T.M.D. Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

UT MD Anderson Cancer Center website

Other Identifiers

DMID 04-036

Identifier Type: -

Identifier Source: secondary_id

2004-0340

Identifier Type: -

Identifier Source: org_study_id