Central Nervous System Neoplasm Clinical Trial
Official title:
A Pilot Single Arm Study of High-Dose Influenza Vaccine Immunogenicity in Patients With Central Nervous System Tumors
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.
PRIMARY OBJECTIVES:
I. To estimate the immunogenicity of high-dose influenza vaccination in patients with central
nervous system tumors.
SECONDARY OBJECTIVES:
I. To assess the geometric mean titer (GMT) in patients after administration of high-dose
influenza vaccination compared to previously determined geometric mean titer (GMT) among 38
patients receiving the standard yearly influenza vaccination.
II. To assess the seroconversion rates (i.e. four-fold rise in titer) compared to previously
determined seroconversion following administration of the standard yearly influenza
vaccination.
III. To assess the seroprotection rates (i.e. post-vaccination titer >= 1:40) compared to
previously determined seroconversion and seroprotection following administration of the
standard yearly influenza vaccination.
TERTIARY OBJECTIVES:
I. To assess the relationship between serologic markers of immune function and response to
high-dose vaccination.
OUTLINE:
Patients receive trivalent influenza vaccine on day 1.
After completion of study, patients are followed up at 28 days and/or 3 months.
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