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

Wake Forest University (WFU)

Status and phase

Completed

Phase 1

Conditions

Central Nervous System Neoplasm

Treatments

Biological: trivalent influenza vaccine

Other: laboratory biomarker analysis

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01941758

CCCWFU 97413 (Other Identifier)

P30CA012197 (U.S. NIH Grant/Contract)

IRB00024870

NCI-2013-01740 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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