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ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)

Primary Purpose

Herpes Zoster

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Zoster Vaccine, Live
Comparator: Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster

Eligibility Criteria

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

Inclusion Criteria:

  • Varicella-history positive, herpes zoster (HZ)-history negative patients
  • 60 years of age and older receiving chronic/maintenance systemic corticosteroid therapy at a daily dose of 5 to 20 mg of prednisone or equivalent for at least the 2 weeks immediately prior to enrollment and expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week primary safety follow-up period (dose may vary within this range during the 6-week postvaccination period)
  • All females enrolling must be postmenopausal

Exclusion Criteria:

  • Patients with a history of hypersensitivity reaction to gelatin or neomycin
  • Prior receipt of varicella or zoster vaccine; prior history of herpes zoster
  • Immune globulin and/or blood products given within 5 months prior to or expected within the 6-week postvaccination period
  • Receipt of any live virus vaccinations within 1 month or receipt of any inactivated vaccinations within 7 days prior to enrollment
  • Known immune deficiency that is caused by a medical condition
  • Any use in the 8 weeks prior to vaccination or for 6 weeks after vaccination other medications which may suppress the immune system including methotrexate, corticosteroids at a daily dose greater than 20 mg of prednisone or equivalent, agents used to treat cancer, or medications which alter the level of the immune response used to treat arthritis or other illnesses
  • Concomitant use of antiviral therapy
  • A history of alcohol abuse or recreational drug use

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    ZOSTAVAX™

    Placebo

    Arm Description

    Participants administered ZOSTAVAX™ on Day 1.

    Participants administered Placebo on Day 1.

    Outcomes

    Primary Outcome Measures

    Number of Participants With Serious Adverse Events (SAE)
    A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.

    Secondary Outcome Measures

    Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination
    The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA).
    Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination.
    The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.

    Full Information

    First Posted
    October 17, 2007
    Last Updated
    March 14, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00546819
    Brief Title
    ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)
    Official Title
    A Phase IIb Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    August 2010 (Actual)
    Study Completion Date
    August 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the study was to assess the safety, tolerability, and immunogenicity of ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Herpes Zoster

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    309 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ZOSTAVAX™
    Arm Type
    Experimental
    Arm Description
    Participants administered ZOSTAVAX™ on Day 1.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants administered Placebo on Day 1.
    Intervention Type
    Biological
    Intervention Name(s)
    Zoster Vaccine, Live
    Other Intervention Name(s)
    V211
    Intervention Description
    A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Serious Adverse Events (SAE)
    Description
    A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.
    Time Frame
    Up to 182 days postvaccination
    Secondary Outcome Measure Information:
    Title
    Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination
    Description
    The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA).
    Time Frame
    42 days postvaccination
    Title
    Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination.
    Description
    The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.
    Time Frame
    42 days postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Varicella-history positive, herpes zoster (HZ)-history negative patients 60 years of age and older receiving chronic/maintenance systemic corticosteroid therapy at a daily dose of 5 to 20 mg of prednisone or equivalent for at least the 2 weeks immediately prior to enrollment and expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week primary safety follow-up period (dose may vary within this range during the 6-week postvaccination period) All females enrolling must be postmenopausal Exclusion Criteria: Patients with a history of hypersensitivity reaction to gelatin or neomycin Prior receipt of varicella or zoster vaccine; prior history of herpes zoster Immune globulin and/or blood products given within 5 months prior to or expected within the 6-week postvaccination period Receipt of any live virus vaccinations within 1 month or receipt of any inactivated vaccinations within 7 days prior to enrollment Known immune deficiency that is caused by a medical condition Any use in the 8 weeks prior to vaccination or for 6 weeks after vaccination other medications which may suppress the immune system including methotrexate, corticosteroids at a daily dose greater than 20 mg of prednisone or equivalent, agents used to treat cancer, or medications which alter the level of the immune response used to treat arthritis or other illnesses Concomitant use of antiviral therapy A history of alcohol abuse or recreational drug use
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    25964168
    Citation
    Russell AF, Parrino J, Fisher CL Jr, Spieler W, Stek JE, Coll KE, Su SC, Xu J, Li X, Schlienger K, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects on chronic/maintenance corticosteroids. Vaccine. 2015 Jun 17;33(27):3129-34. doi: 10.1016/j.vaccine.2015.04.090. Epub 2015 May 8.
    Results Reference
    result

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    ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)

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