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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941758
• Other study ID #: IRB00024870
• Secondary ID: NCI-2013-01740CC
• Status: Completed
• Phase: Phase 1
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasm
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Biological:
• trivalent influenza vaccine

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital	Baltimore	Maryland
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical factors such as treatment, disease status, and use of glucocorticoids	Logistic regression models adjusting for age and gender will be used to assess the relationship between seroconversion and clinical factors.	Up to 3 months
Other	Serologic markers of immune function	To assess the relationship between serologic markers of immune function and response to vaccination, student's t-test will be used.	Up to 3 months
Other	Response to vaccination	To assess the relationship between serologic markers of immune function and response to vaccination, student's t-test will be used.	Up to 3 months
Primary	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		Baseline
Primary	Estimation of GMT seroconversion, defined as the percentage of patients with at least a four-fold increase in HI antibodies		Day 28
Secondary	GMT	Continuous values will be analyzed using Wilcoxon rank sum tests to compare high dose influenza vaccine to previously reported data on immunogenicity to the standard trivalent inactivated vaccine.	Up to 3 months
Secondary	Seroconversion	Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.	Up to 3 months
Secondary	Seroprotection rate, defined as the percentage of patients with a serum HI antibody of at least 1:40	Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.	Up to 3 months