search
Back to results

Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trivalent inactivated influenza vaccine
Trivalent Baculovirus-expressed Influenza HA vaccine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring influenza vaccine, baculovirus, immunogenicity, lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Arm D

Arm C

Arm B

Arm A

Arm Description

25 subjects receive Recombinant rHA0 vaccine at 135 mcg per rHA0, via IM injection on Day 0

25 subjects receive Recombinant rHA0 vaccine at 45 mcg per rHA0, via IM injection on Day 0

25 subjects receive Recombinant rHA0 vaccine at 15 mcg per rHA0, via IM injection on Day 0

25 subjects receive Standard TIV at 15 mcg HA per virus, in a total volume of 0.5 mL, by deep intramuscular (IM) injection on Day 0

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 24, 2006
Last Updated
December 4, 2014
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00307177
Brief Title
Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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 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 lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza vaccine, baculovirus, immunogenicity, lymphoma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm D
Arm Type
Experimental
Arm Description
25 subjects receive Recombinant rHA0 vaccine at 135 mcg per rHA0, via IM injection on Day 0
Arm Title
Arm C
Arm Type
Experimental
Arm Description
25 subjects receive Recombinant rHA0 vaccine at 45 mcg per rHA0, via IM injection on Day 0
Arm Title
Arm B
Arm Type
Experimental
Arm Description
25 subjects receive Recombinant rHA0 vaccine at 15 mcg per rHA0, via IM injection on Day 0
Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
25 subjects receive Standard TIV at 15 mcg HA per virus, in a total volume of 0.5 mL, by deep intramuscular (IM) injection on Day 0
Intervention Type
Biological
Intervention Name(s)
Trivalent inactivated influenza vaccine
Intervention Description
Standard Trivalent inactivated influenza vaccine, licensed. Arm A receives standard dose of 15 mcg IM on day 0.
Intervention Type
Biological
Intervention Name(s)
Trivalent Baculovirus-expressed Influenza HA vaccine
Intervention Description
Trivalent Baculovirus-expressed influenza HA vaccine (Recombinant rHA0): Arms B, C and D receive 15 mcg, 45 mcg or 135 mcg IM dose on Day 0.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Trivalent Baculovirus-expressed Influenza HA Vaccine in Adults With Non-Hodgkin's B-cell Lymphoma

We'll reach out to this number within 24 hrs