NCT01941758

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.

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_1

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

September 10, 2013

Last Update Submit

July 2, 2018

Conditions

Central Nervous System Neoplasm

Outcome Measures

Primary Outcomes (2)

  • 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

    Baseline

  • Estimation of GMT seroconversion, defined as the percentage of patients with at least a four-fold increase in HI antibodies

    Day 28

Secondary Outcomes (3)

  • GMT

    Up to 3 months

  • Seroconversion

    Up to 3 months

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

    Up to 3 months

Other Outcomes (3)

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

    Up to 3 months

  • Serologic markers of immune function

    Up to 3 months

  • Response to vaccination

    Up to 3 months

Study Arms (1)

Basic science (trivalent influenza vaccine)

EXPERIMENTAL

Patients receive trivalent influenza vaccine on day 1.

Biological: trivalent influenza vaccineOther: laboratory biomarker analysis

Interventions

trivalent influenza vaccineBIOLOGICAL
Also known as: Flushield, Fluvirin, Fluzone, Influenza Vaccine
Basic science (trivalent influenza vaccine)
laboratory biomarker analysisOTHER

Correlative studies

Basic science (trivalent influenza vaccine)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Glenn Lesser

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 5, 2018

Record last verified: 2018-07

Locations

US(2)