Clinical trial NCT01941758: High-Dose Trivalent Influenza Vaccine in Inducing Immune Response Patients With Central Nervous System Tumors
Official title: A Pilot Single Arm Study of High-Dose Influenza Vaccine Immunogenicity in Patients With Central Nervous System Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Central Nervous System Neoplasm
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-09-13
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Estimation of geometric mean titer (GMT) seroconversion, defined as the percentage of patients with at least a four-fold increase in hemagglutinin inhibition (HI) antibodies
timeFrame: Baseline
measure: Estimation of GMT seroconversion, defined as the percentage of patients with at least a four-fold increase in HI antibodies
timeFrame: Day 28
Secondary outcomes:
measure: GMT
timeFrame: Up to 3 months
measure: Seroconversion
timeFrame: Up to 3 months
measure: Seroprotection rate, defined as the percentage of patients with a serum HI antibody of at least 1:40
timeFrame: Up to 3 months
Other outcomes:
measure: Clinical factors such as treatment, disease status, and use of glucocorticoids
timeFrame: Up to 3 months
measure: Serologic markers of immune function
timeFrame: Up to 3 months
measure: Response to vaccination
timeFrame: Up to 3 months
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
state: Maryland
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Glenn Lesser
role: PRINCIPAL_INVESTIGATOR
References: