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

NCT01474174 | Completed

• 3 other identifiers: IRB00018422NCI-2011-03033CCCWFU 98411
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Central Nervous System Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Relationship between a variety of clinical factors and seroconversion following influenza vaccination

  6 months

• Relationship between serologic markers of immune function and response to vaccination

  6 months

Study Arms (1)

Supportive care (vaccine therapy)

Patients receive trivalent influenza vaccine IM on day 0.

Biological: trivalent influenza vaccine; Other: laboratory biomarker analysis

Interventions

trivalent influenza vaccine BIOLOGICAL

Given IM

Also known as: FluMist, Flushield, Fluvirin, Fluzone, Influenza Vaccine

Supportive care (vaccine therapy)

laboratory biomarker analysis OTHER

Correlative studies

Supportive care (vaccine therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with primary central nervous system turmors

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Influenza Vaccines; FluMist

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Glenn Lesser

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: November 18, 2011
• Study Start: September 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

US (1)