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NCT Number: NCT01941758

High-Dose Trivalent Influenza Vaccine in Inducing Immune Response Patients With Central Nervous System Tumors

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.

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Key information

Conditions

Central Nervous System Neoplasm Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Baltimore, Maryland, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 willing to receive the Fluzone® high-dose seasonal influenza vaccine
  • Patients must be willing and able to sign an Institutional Review Board (IRB)-approved written informed consent document

Exclusion criteria

  • Patients unable to receive the high-dose 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, Guillain-Barré syndrome, or other contraindication to the vaccine
  • Patients who have received the 2013-2014 annual influenza vaccine prior to being considered for enrollment on this study

Treatment and study plan

Trivalent Influenza Vaccine

Biological

Other names: Flushield, Fluvirin, Fluzone, Influenza Vaccine

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Estimation of geometric mean titer (GMT) seroconversion, defined as the percentage of patients with at least a four-fold increase in hemagglutinin inhibition (HI) antibodies

    Time frame: Baseline

  2. Estimation of GMT seroconversion, defined as the percentage of patients with at least a four-fold increase in HI antibodies

    Time frame: Day 28

Secondary outcomes

  1. GMT

    Time frame: Up to 3 months

    Continuous values will be analyzed using Wilcoxon rank sum tests to compare high dose influenza vaccine to previously reported data on immunogenicity to the standard trivalent inactivated vaccine.

  2. Seroconversion

    Time frame: Up to 3 months

    Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.

  3. Seroprotection rate, defined as the percentage of patients with a serum HI antibody of at least 1:40

    Time frame: Up to 3 months

    Categorical variables will be analyzed using chi-square or Fisher exact tests when necessary or appropriate.

Other outcomes

  1. Clinical factors such as treatment, disease status, and use of glucocorticoids

    Time frame: Up to 3 months

    Logistic regression models adjusting for age and gender will be used to assess the relationship between seroconversion and clinical factors.

  2. Serologic markers of immune function

    Time frame: Up to 3 months

    To assess the relationship between serologic markers of immune function and response to vaccination, student's t-test will be used.

  3. Response to vaccination

    Time frame: Up to 3 months

    To assess the relationship between serologic markers of immune function and response to vaccination, student's t-test will be used.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Single Arm Study of High-Dose Influenza Vaccine Immunogenicity in Patients With Central Nervous System Tumors

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2013
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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