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High-Dose Trivalent Influenza Vaccine in Inducing Immune Response Patients With Central Nervous System Tumors

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ClinicalTrials.gov Identifier: NCT01941758
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : July 4, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
This pilot clinical trial studies high-dose trivalent influenza vaccine in inducing immune response patients with central nervous system tumors. Studying samples of blood in the laboratory from patients receiving trivalent influenza vaccine may help doctors learn more about the effects of trivalent influenza vaccine on cells. It may also help doctors understand how well patients respond to treatment.

Condition or disease Intervention/treatment Phase
Central Nervous System Neoplasm Biological: trivalent influenza vaccine Other: laboratory biomarker analysis Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. To estimate the immunogenicity of high-dose influenza vaccination in patients with central nervous system tumors.

SECONDARY OBJECTIVES:

I. To assess the geometric mean titer (GMT) in patients after administration of high-dose influenza vaccination compared to previously determined geometric mean titer (GMT) among 38 patients receiving the standard yearly influenza vaccination.

II. To assess the seroconversion rates (i.e. four-fold rise in titer) compared to previously determined seroconversion following administration of the standard yearly influenza vaccination.

III. To assess the seroprotection rates (i.e. post-vaccination titer >= 1:40) compared to previously determined seroconversion and seroprotection following administration of the standard yearly influenza vaccination.

TERTIARY OBJECTIVES:

I. To assess the relationship between serologic markers of immune function and response to high-dose vaccination.

OUTLINE:

Patients receive trivalent influenza vaccine on day 1.

After completion of study, patients are followed up at 28 days and/or 3 months.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Single Arm Study of High-Dose Influenza Vaccine Immunogenicity in Patients With Central Nervous System Tumors
Study Start Date : November 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Basic science (trivalent influenza vaccine)
Patients receive trivalent influenza vaccine on day 1.
Biological: trivalent influenza vaccine
Other Names:
  • Flushield
  • Fluvirin
  • Fluzone
  • Influenza Vaccine

Other: laboratory biomarker analysis
Correlative studies




Primary Outcome Measures :
  1. Estimation of geometric mean titer (GMT) seroconversion, defined as the percentage of patients with at least a four-fold increase in hemagglutinin inhibition (HI) antibodies [ Time Frame: Baseline ]
  2. Estimation of GMT seroconversion, defined as the percentage of patients with at least a four-fold increase in HI antibodies [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. GMT [ Time Frame: Up to 3 months ]
    Continuous values will be analyzed using Wilcoxon rank sum tests to compare high dose influenza vaccine to previously reported data on immunogenicity to the standard trivalent inactivated vaccine.

  2. Seroconversion [ Time Frame: Up to 3 months ]
    Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.

  3. Seroprotection rate, defined as the percentage of patients with a serum HI antibody of at least 1:40 [ Time Frame: Up to 3 months ]
    Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.


Other Outcome Measures:
  1. Clinical factors such as treatment, disease status, and use of glucocorticoids [ Time Frame: Up to 3 months ]
    Logistic regression models adjusting for age and gender will be used to assess the relationship between seroconversion and clinical factors.

  2. Serologic markers of immune function [ Time Frame: Up to 3 months ]
    To assess the relationship between serologic markers of immune function and response to vaccination, student's t-test will be used.

  3. Response to vaccination [ Time Frame: Up to 3 months ]
    To assess the relationship between serologic markers of immune function and response to vaccination, student's t-test will be used.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a clinical diagnosis of a primary central nervous system tumor
  • Patients must be eligible to receive the influenza vaccine
  • Patients must be willing to receive the Fluzone® high-dose seasonal influenza vaccine
  • Patients must be willing and able to sign an Institutional Review Board (IRB)-approved written informed consent document

Exclusion Criteria:

  • Patients unable to receive the high-dose influenza vaccine due to history of allergy to egg proteins, allergy to influenza vaccine component, acute febrile illness at the time of proposed vaccine administration, history of clinically or virologically confirmed influenza infection in the previous 6 months, contraindication to intramuscular injections, Guillain-Barré syndrome, or other contraindication to the vaccine
  • Patients who have received the 2013-2014 annual influenza vaccine prior to being considered for enrollment on this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941758


Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Glenn Lesser Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01941758     History of Changes
Other Study ID Numbers: IRB00024870
NCI-2013-01740 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CCCWFU 97413 ( Other Identifier: Comprehensive Cancer Center of Wake Forest University )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs