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

Wake Forest University (WFU)

Status: Completed

Conditions: Central Nervous System Neoplasm

Treatments: Other: laboratory biomarker analysis; Biological: trivalent influenza vaccine

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01474174

CCCWFU 98411 (Other Identifier)

IRB00018422

NCI-2011-03033 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

38 participants in 1 patient group

Supportive care (vaccine therapy)

Description:

Patients receive trivalent influenza vaccine IM on day 0.

Treatment:

Other: laboratory biomarker analysis

Biological: trivalent influenza vaccine