Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT01941758
Status:
COMPLETED
Last Update Posted:
2018-07-05
First Post:
2013-09-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-Dose Trivalent Influenza Vaccine in Inducing Immune Response Patients With Central Nervous System Tumors
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
A Pilot Single Arm Study of High-Dose Influenza Vaccine Immunogenicity in Patients With Central Nervous System Tumors
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-01740 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CCCWFU 97413 | OTHER | Comprehensive Cancer Center of Wake Forest University | View | |
| P30CA012197 | NIH | None | https://reporter.nih.gov/quic… | View |