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

NCT00307177 | Completed Phase 2

• 1 other identifier: 04-036
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

influenza vaccine, baculovirus, immunogenicity, lymphoma

Study Arms (4)

Arm D

EXPERIMENTAL

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

Biological: Trivalent Baculovirus-expressed Influenza HA vaccine

Arm C

EXPERIMENTAL

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

Biological: Trivalent Baculovirus-expressed Influenza HA vaccine

Arm B

EXPERIMENTAL

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

Biological: Trivalent Baculovirus-expressed Influenza HA vaccine

Arm A

ACTIVE COMPARATOR

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

Biological: Trivalent inactivated influenza vaccine

Interventions

Trivalent inactivated influenza vaccine BIOLOGICAL

Standard Trivalent inactivated influenza vaccine, licensed. Arm A receives standard dose of 15 mcg IM on day 0.

Arm A

Trivalent Baculovirus-expressed Influenza HA vaccine BIOLOGICAL

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.

Arm B; Arm C; Arm D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Influenza, Human; Lymphoma

Interventions

trivalent baculovirus-expressed influenza-virus hemagglutinin vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 24, 2006
• First Posted: March 27, 2006
• Study Start: August 1, 2004
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: December 5, 2014

Record last verified: 2006-11

Locations

US (1)