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CompletedNCT01941758Updated Jul 5, 2018

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

A Phase 1 interventional study of trivalent influenza vaccine and laboratory biomarker analysis in Central Nervous System Neoplasm, sponsored by Wake Forest University Health Sciences. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-05.

Sponsored by Wake Forest University Health Sciences · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Nov 2014, 11 years 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Central Nervous System Neoplasm
03

In context

Nervous System Neoplasms

538 studies on the registry are indexed under Nervous System Neoplasms; 14 are open to participants now.

This study's enrollment of 28 is below the median of 35 across 379 interventional studies indexed under Nervous System Neoplasms.

Browse Nervous System Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Basic science (trivalent influenza vaccine)

    Patients receive trivalent influenza vaccine on day 1.

    Biological: trivalent influenza vaccine · Other: laboratory biomarker analysis

Interventions

  • Biologicaltrivalent influenza vaccine

    Also known as: Flushield, Fluvirin, Fluzone, Influenza Vaccine

  • Otherlaboratory biomarker analysis

    Correlative studies

06

What researchers measure

Primary outcomes

  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 outcomes

  1. GMT

    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.

    Time frame: Up to 3 months

  2. Seroconversion

    Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.

    Time frame: Up to 3 months

  3. Seroprotection rate, defined as the percentage of patients with a serum HI antibody of at least 1:40

    Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.

    Time frame: Up to 3 months

Other outcomes

  1. Clinical factors such as treatment, disease status, and use of glucocorticoids

    Logistic regression models adjusting for age and gender will be used to assess the relationship between seroconversion and clinical factors.

    Time frame: Up to 3 months

  2. Serologic markers of immune function

    To assess the relationship between serologic markers of immune function and response to vaccination, student's t-test will be used.

    Time frame: Up to 3 months

  3. Response to vaccination

    To assess the relationship between serologic markers of immune function and response to vaccination, student's t-test will be used.

    Time frame: Up to 3 months

07

Study locations

2 sites
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
    Baltimore, Maryland 21231, United States
  • Comprehensive Cancer Center of Wake Forest University
    Winston-Salem, North Carolina 27157, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01941758
Lead sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 13, 2013
Start date
Nov 2013
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Jul 5, 2018

Study contacts

Glenn Lesser
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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