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Trivalent Influenza Vaccine in Preventing Flu in Patients With Central Nervous System Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01474174
First Posted: November 18, 2011
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
This pilot clinical trial studies trivalent influenza vaccine in preventing flu in patients with central nervous system (CNS) tumors. Flu vaccine may help the body build an effective immune response and help prevent flu in patients who are receiving chemotherapy for CNS tumors

Condition Intervention
Central Nervous System Neoplasm Biological: trivalent influenza vaccine Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: A Pilot Study of Influenza Vaccine Efficacy in Patients With Central Nervous System Tumors

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in HI titers from the pre-vaccination baseline [ Time Frame: 6 months ]
    Seroconversion rate will be defined as the percentage of patients with at least a four-fold increase in HI antibodies between baseline and follow up. Seroprotection rate will be defined as the percentage of patients with a serum HI antibody of at least 1:40. The relationship between seroconversion and various clinical variables including therapy status (active vs longterm follow-up), glucorticoid dose and immune function will be measured. Seroconversion and seroprotection rate comparisons will be made to publish normative data for the general population.


Secondary Outcome Measures:
  • Efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40 [ Time Frame: 6 months ]
  • Relationship between a variety of clinical factors and seroconversion following influenza vaccination [ Time Frame: 6 months ]
  • Relationship between serologic markers of immune function and response to vaccination [ Time Frame: 6 months ]

Enrollment: 38
Actual Study Start Date: September 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Supportive care (vaccine therapy)
Patients receive trivalent influenza vaccine IM on day 0.
Biological: trivalent influenza vaccine
Given IM
Other Names:
  • FluMist
  • Flushield
  • Fluvirin
  • Fluzone
  • Influenza Vaccine
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. The primary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in hemagglutinin inhibition (HI) titers from the pre-vaccination baseline.

SECONDARY OBJECTIVES:

I. A secondary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40.

II. The secondary objectives of this pilot study include an assessment of the relationship between a variety of clinical factors and seroconversion following influenza vaccination.

III. Subgroup analyses will include an investigation of seroconversion and treatment (actively receiving chemotherapy, radiation therapy or both), disease status (active treatment vs long term followup), and use and dose of glucocorticoids.

TERTIARY OBJECTIVES:

I. An additional area of interest which will be further explored in this pilot study is an assessment of the relationship between serologic markers of immune function and response to vaccination.

OUTLINE:

Patients receive trivalent influenza vaccine intramuscularly (IM) on day 0.

After completion of study treatment, patients are followed up at 14 days, 21 days, and 3 and/or 6 months.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with primary central nervous system turmors
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 able to provide written informed consent

Exclusion Criteria:

  • Patients unable to receive the 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, Guillan-Barré syndrome, or other contraindication to the vaccine
  • Patients who have received the 2011-2012 annual influenza vaccine prior to being considered for enrollment on this study
  Contacts and Locations
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): NCT01474174


Locations
United States, North Carolina
Wake Forest University Health Sciences
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
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01474174     History of Changes
Other Study ID Numbers: CCCWFU 98411
NCI-2011-03033 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: October 21, 2011
First Posted: November 18, 2011
Last Update Posted: August 1, 2017
Last Verified: March 2016

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