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

Phase 1

Completed

• Conditions: Central Nervous System Neoplasm
• Interventions: Biological: trivalent influenza vaccine; Other: laboratory biomarker analysis

• Registration Number: NCT01941758
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-13
• Study Start: 2013-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Basic science (trivalent influenza vaccine)	trivalent influenza vaccine	Patients receive trivalent influenza vaccine on day 1.
Basic science (trivalent influenza vaccine)	laboratory biomarker analysis	Patients receive trivalent influenza vaccine on day 1.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
GMT	Up to 3 months	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.
Seroconversion	Up to 3 months	Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.
Seroprotection rate, defined as the percentage of patients with a serum HI antibody of at least 1:40	Up to 3 months	Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.

Trial Locations

Locations (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States