A Pilot Study of Influenza Vaccine Efficacy in Patients With Central Nervous System Tumors
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.
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.
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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.
Wake Forest University
United States: Institutional Review Board
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