Trivalent Influenza Vaccine in Preventing Flu in Patients With Central Nervous System Tumors

Central Nervous System Neoplasm Clinical Trial

Official title:

A Pilot Study of Influenza Vaccine Efficacy in Patients With Central Nervous System Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474174
• Other study ID #: IRB00018422
• Secondary ID: NCI-2011-03033CC
• Status: Completed
• Start date: September 2011
• Est. completion date: July 2012

Study information

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

Clinical Trial Summary

This pilot clinical trial studies trivalent influenza vaccine in preventing flu in patients with central nervous system (CNS) tumors. Flu vaccine may help the body build an effective immune response and help prevent flu in patients who are receiving chemotherapy for CNS tumors

Description:

PRIMARY OBJECTIVES:

I. The primary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in hemagglutinin inhibition (HI) titers from the pre-vaccination baseline.

SECONDARY OBJECTIVES:

I. A secondary objective of this pilot study is to assess the efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40.

II. The secondary objectives of this pilot study include an assessment of the relationship between a variety of clinical factors and seroconversion following influenza vaccination.

III. Subgroup analyses will include an investigation of seroconversion and treatment (actively receiving chemotherapy, radiation therapy or both), disease status (active treatment vs long term followup), and use and dose of glucocorticoids.

TERTIARY OBJECTIVES:

I. An additional area of interest which will be further explored in this pilot study is an assessment of the relationship between serologic markers of immune function and response to vaccination.

OUTLINE:

Patients receive trivalent influenza vaccine intramuscularly (IM) on day 0.

After completion of study treatment, patients are followed up at 14 days, 21 days, and 3 and/or 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• 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 able to provide written informed consent

Exclusion Criteria:

• Patients unable to receive the 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, Guillan-Barré syndrome, or other contraindication to the vaccine

• Patients who have received the 2011-2012 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
Given IM

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	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
Primary	Efficacy of influenza vaccination in patients with central nervous system tumors as defined by a four-fold increase in HI titers from the pre-vaccination baseline	Seroconversion rate will be defined as the percentage of patients with at least a four-fold increase in HI antibodies between baseline and follow up. Seroprotection rate will be defined as the percentage of patients with a serum HI antibody of at least 1:40. The relationship between seroconversion and various clinical variables including therapy status (active vs longterm follow-up), glucorticoid dose and immune function will be measured. Seroconversion and seroprotection rate comparisons will be made to publish normative data for the general population.	6 months
Secondary	Efficacy of influenza vaccination in patients with central nervous system tumors as defined by a serum post-vaccination HI titer of at least 1:40		6 months
Secondary	Relationship between a variety of clinical factors and seroconversion following influenza vaccination		6 months
Secondary	Relationship between serologic markers of immune function and response to vaccination		6 months