High-Dose Trivalent Influenza Vaccine in Inducing Immune Response Patients With Central Nervous System Tumors

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.

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 willing to receive the Fluzone® high-dose seasonal influenza vaccine

- Patients must be willing and able to sign an Institutional Review Board
(IRB)-approved written informed consent document

Exclusion Criteria:

- Patients unable to receive the high-dose 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, Guillain-Barré syndrome, or other contraindication to the
vaccine

- Patients who have received the 2013-2014 annual influenza vaccine prior to being
considered for enrollment on this study