NCT01474174

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Central Nervous System Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	trivalent influenza vaccine	Given IM
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-11-18
• Last updated: 2018-07-03

Locations

1 site across 1 country: United States