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ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

Primary Purpose

Shingles

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
ZOSTAVAX
Sponsored by
Louis Stokes VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Shingles focused on measuring solid tumor, chemotherapy, vaccine

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Solid organ tumor patients that have at least 14 days between entry into the study with ZOSTAVAX vaccination and initial therapy for their malignancy that will include chemotherapy alone or surgery with subsequent chemotherapy plus or minus radiation therapy
  • A plan for chemotherapy that at the onset at least an anticipated stop date within 3-6 months of our sample collection phase of the study

Exclusion Criteria:

  • Prior history of HZ or shingles vaccine
  • Systemic chemotherapy < 3 months prior to enrollment
  • Any history of hematologic malignancy, HIV/AIDS, hematopoietic stem cell transplant, or other cellular immunodeficiency state
  • Those receiving immunomodulating drugs at the time of vaccination such as prednisone methotrexate, azathioprine, mercaptopurine, or other biologics including TNF-alpha inhibitors
  • Widespread metastatic tumor with bone marrow involvement

  • Indefinite duration palliative chemotherapy subjects

    • Inability to communicate with the study staff or bring unable to consent for themselves
    • History of anaphylactic/anaphylactiod reaction to gelatin, neomycin, or other components of the vaccine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    ZOSTAVAX

    Control

    Arm Description

    ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection

    There is no drug given in this arm.

    Outcomes

    Primary Outcome Measures

    Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT)
    To examine the cellular immunologic efficacy as measured by IFN-gamma assays of ZOSTAVAX given to individuals with solid organ tumors at least 14 days prior to initiation of chemotherapy or surgery and then chemotherapy. Changes in ZOSTAVAX-specific IFN-gamma spot forming units will be measured by ELISPOT.
    Measuring the Safety of ZOSTAVAX Given to Chemotherapy Patients (Vaccine Report Card (VRC) to Document Injection-site Adverse Experiences, Systemic Clinical Adverse Experiences (AEs), Concomitant Medications, and Oral Temperatures
    To asses the safety of ZOSTAVAX given to subjects that will receive chemotherapy or surgery and then chemotherapy for solid organ tumor at least 14 days after vaccination. Safety and tolerability data will be collected for all subjects throughout the study. Each subject will be given a Vaccine Report Card (VRC) to document injection-site adverse experiences, systemic clinical adverse experiences (AEs), concomitant medications, and oral temperatures (only if feeling feverish) noted during the 14-day post-vaccination period. Participants will be asked to notify the study personnel immediately if any unexpected or serious adverse experience (SAE) occurs. At all study visits subjects will be asked about any unreported SAEs. All AEs and SAEs will be recorded on an AE/SAE case report form and relationship to study vaccine will be determined by the site investigator.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 7, 2015
    Last Updated
    April 5, 2018
    Sponsor
    Louis Stokes VA Medical Center
    Collaborators
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02444936
    Brief Title
    ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
    Official Title
    A Pilot Study Using a Randomized Design to Evaluate the Immunologic Efficacy and Safety of ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2015 (Actual)
    Primary Completion Date
    May 1, 2018 (Anticipated)
    Study Completion Date
    May 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Louis Stokes VA Medical Center
    Collaborators
    Duke University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates if the shingles vaccine works in those persons that receive it before they receive chemotherapy for solid organ tumors. Half of the participants will receive the ZOSTAVAX shingle vaccine and half of the participants will not received anything.
    Detailed Description
    This study is a single blind randomized clinical trial measuring the immunologic efficacy of ZOSTAVAX vs. no vaccine in 60 adults with solid organ tumors before, during and after chemotherapy. The personnel performing the laboratory studies will be blinded to vaccine vs. no vaccine. In a pilot study of an FDA approved vaccine that is being used within the parameters of the package insert and ACIP recommendations, placebo vaccine is not required to access our key primary immunologic endpoint.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shingles
    Keywords
    solid tumor, chemotherapy, vaccine

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ZOSTAVAX
    Arm Type
    Active Comparator
    Arm Description
    ZOSTAVAX shingles vaccine Zoster vaccine live Single 0.65mL subcutaneous injection
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    There is no drug given in this arm.
    Intervention Type
    Drug
    Intervention Name(s)
    ZOSTAVAX
    Other Intervention Name(s)
    Voster vaccine live
    Intervention Description
    Shingles vaccine
    Primary Outcome Measure Information:
    Title
    Measuring the Efficacy of ZOSTAVAX in Chemotherapy Patients (Changes in ZOSTAVAX-specific IFN-gamma Spot Forming Units Will be Measured by ELISPOT)
    Description
    To examine the cellular immunologic efficacy as measured by IFN-gamma assays of ZOSTAVAX given to individuals with solid organ tumors at least 14 days prior to initiation of chemotherapy or surgery and then chemotherapy. Changes in ZOSTAVAX-specific IFN-gamma spot forming units will be measured by ELISPOT.
    Time Frame
    3 years
    Title
    Measuring the Safety of ZOSTAVAX Given to Chemotherapy Patients (Vaccine Report Card (VRC) to Document Injection-site Adverse Experiences, Systemic Clinical Adverse Experiences (AEs), Concomitant Medications, and Oral Temperatures
    Description
    To asses the safety of ZOSTAVAX given to subjects that will receive chemotherapy or surgery and then chemotherapy for solid organ tumor at least 14 days after vaccination. Safety and tolerability data will be collected for all subjects throughout the study. Each subject will be given a Vaccine Report Card (VRC) to document injection-site adverse experiences, systemic clinical adverse experiences (AEs), concomitant medications, and oral temperatures (only if feeling feverish) noted during the 14-day post-vaccination period. Participants will be asked to notify the study personnel immediately if any unexpected or serious adverse experience (SAE) occurs. At all study visits subjects will be asked about any unreported SAEs. All AEs and SAEs will be recorded on an AE/SAE case report form and relationship to study vaccine will be determined by the site investigator.
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Solid organ tumor patients that have at least 14 days between entry into the study with ZOSTAVAX vaccination and initial therapy for their malignancy that will include chemotherapy alone or surgery with subsequent chemotherapy plus or minus radiation therapy A plan for chemotherapy that at the onset at least an anticipated stop date within 3-6 months of our sample collection phase of the study Exclusion Criteria: Prior history of HZ or shingles vaccine Systemic chemotherapy < 3 months prior to enrollment Any history of hematologic malignancy, HIV/AIDS, hematopoietic stem cell transplant, or other cellular immunodeficiency state Those receiving immunomodulating drugs at the time of vaccination such as prednisone methotrexate, azathioprine, mercaptopurine, or other biologics including TNF-alpha inhibitors Widespread metastatic tumor with bone marrow involvement Indefinite duration palliative chemotherapy subjects Inability to communicate with the study staff or bring unable to consent for themselves History of anaphylactic/anaphylactiod reaction to gelatin, neomycin, or other components of the vaccine
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David H. Canaday, MD
    Organizational Affiliation
    Cleveland VA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    ZOSTAVAX in Persons Imminently Receiving Chemotherapy for Solid Organ Tumors

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