Trivalent Influenza Vaccine in Preventing Flu in Patients With Central Nervous System Tumors
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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
| Condition | Intervention |
|---|---|
|
Central Nervous System Neoplasm |
Biological: trivalent influenza vaccine Other: laboratory biomarker analysis |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Pilot Study of Influenza Vaccine Efficacy in Patients With Central Nervous System Tumors |
- 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
- 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Relationship between a variety of clinical factors and seroconversion following influenza vaccination [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Relationship between serologic markers of immune function and response to vaccination [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2011 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Supportive care (vaccine therapy)
Patients receive trivalent influenza vaccine IM on day 0.
|
Biological: trivalent influenza vaccine
Given IM
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Glenn Lesser | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01474174 History of Changes |
| Other Study ID Numbers: | CCCWFU 98411, NCI-2011-03033 |
| Study First Received: | October 21, 2011 |
| Last Updated: | August 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasms Influenza, Human Nervous System Neoplasms Central Nervous System Neoplasms Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Neoplasms by Site Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013