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

A Pilot Study of Influenza Vaccine Efficacy in Patients With Central Nervous System Tumors

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

Study Overview

• Status: Completed
• Conditions: Central Nervous System Neoplasm
• Intervention / Treatment: Other: laboratory biomarker analysis; Biological: trivalent influenza vaccine

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.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with primary central nervous system turmors

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Supportive care (vaccine therapy); Patients receive trivalent influenza vaccine IM on day 0.	Other: laboratory biomarker analysis; Correlative studies; Biological: trivalent influenza vaccine; Given IM; Other Names: FluMist; Flushield; Fluzone; Fluvirin; Influenza Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	6 months
Relationship between a variety of clinical factors and seroconversion following influenza vaccination	6 months
Relationship between serologic markers of immune function and response to vaccination	6 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (Estimate): November 18, 2011

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Nervous System Neoplasms; Central Nervous System Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: IRB00018422; NCI-2011-03033 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 98411 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No