NCT01941758

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Central Nervous System Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	trivalent influenza vaccine
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-09-13
• Last updated: 2018-07-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study