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

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.

Study Overview

• Status: Completed
• Conditions: Central Nervous System Neoplasm
• Intervention / Treatment: Other: laboratory biomarker analysis; Biological: trivalent influenza vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Basic science (trivalent influenza vaccine); Patients receive trivalent influenza vaccine on day 1.	Other: laboratory biomarker analysis; Correlative studies; Biological: trivalent influenza vaccine; Other Names: Flushield; Fluzone; Fluvirin; Influenza Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Estimation of GMT seroconversion, defined as the percentage of patients with at least a four-fold increase in HI antibodies	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Seroconversion	Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.	Up to 3 months
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: September 10, 2013
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Nervous System Neoplasms; Central Nervous System Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: IRB00024870; P30CA012197 (U.S. NIH Grant/Contract); NCI-2013-01740 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CCCWFU 97413 (Other Identifier: Comprehensive Cancer Center of Wake Forest University)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No