NCT00307710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

2.5 years

First QC Date

March 24, 2006

Last Update Submit

July 27, 2012

Conditions

Lymphoma

Keywords

Non-Hodgkin's LymphomaInfluenza VaccinationTrivalent Baculovirus-Expressed Influenza HA vaccineAntineoplastic Therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 Years

Study Arms (4)

A: Trivalent Subvirion Vaccine

EXPERIMENTAL

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

Biological: Trivalent Baculovirus-expressed Influenza HA vaccine

B: Vaccine 15 μg

EXPERIMENTAL

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

Biological: Trivalent Baculovirus-expressed Influenza HA vaccine

C: Vaccine 45 μg

EXPERIMENTAL

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

Biological: Trivalent Baculovirus-expressed Influenza HA vaccine

D: Vaccine 135 μg

EXPERIMENTAL

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

Biological: Trivalent Baculovirus-expressed Influenza HA vaccine

Interventions

Trivalent Baculovirus-expressed Influenza HA vaccineBIOLOGICAL

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.

A: Trivalent Subvirion VaccineB: Vaccine 15 μgC: Vaccine 45 μgD: Vaccine 135 μg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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).
  • Patients greater than or equal to 18 years of age who have given informed consent and signed the IRB approved informed consent.
  • 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.
  • 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.

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 Immunodeficiency Virus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LymphomaLymphoma, Non-HodgkinInfluenza, Human

Interventions

trivalent baculovirus-expressed influenza-virus hemagglutinin vaccine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Amar Safdar, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2006

First Posted

March 28, 2006

Study Start

August 1, 2004

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

July 31, 2012

Record last verified: 2012-07

Locations

US(1)