search
Back to results

Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)

Primary Purpose

Herpes Zoster, Varicella-zoster Vaccine

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Zoster Vaccine, Live
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 focused on measuring Shingles, Vaccine

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All Groups:

    • Must not have a fever of ≥100.4° F on the day of vaccination
    • Any underlying chronic illness must be in stable condition
    • History of varicella or residence in a VZV-endemic area for ≥30 years

  • Group 1:

    • 70 years of age or older
    • Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study

  • Group 2:

    • 70 years of age or older

  • Group 3:

    • 60 to 69 years of age

  • Group 4:

    • 50 to 59 years of age

Exclusion Criteria:

  • All Groups:

    • History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin
    • Prior history of herpes zoster
    • Pregnant or breast-feeding, or expecting to conceive within the duration of the study
    • Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination
    • Received any other vaccine within 4 weeks prevaccination
    • On immunosuppressive therapy
    • Has known or suspected immune dysfunction
    • Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir.

  • Groups 2, 3, and 4:

    • Has previously received any varicella or zoster vaccine

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Group 1: Booster Dose Participants ≥70 years of age

    Group 2: First Dose Participants ≥70 years of age

    Group 3: First Dose Participants ≥60 and <70 years of age

    Group 4: First Dose Participants ≥50 and <60 years of age

    Arm Description

    Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 NCT00007501)

    Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age

    Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live

    Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live

    Outcomes

    Primary Outcome Measures

    Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)
    VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
    Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers
    VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.

    Secondary Outcome Measures

    Number of Participants Reporting One or More Adverse Experiences
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.

    Full Information

    First Posted
    November 19, 2010
    Last Updated
    March 15, 2017
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    University of Colorado, Denver, Duke University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01245751
    Brief Title
    Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)
    Official Title
    Safety, Tolerability and Immunogenicity of a Booster Dose of ZOSTAVAX™ Administered ≥10 Years After a First Dose Compared With a First Dose of ZOSTAVAX™
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2011 (undefined)
    Primary Completion Date
    July 2012 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    University of Colorado, Denver, Duke University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study was conducted to obtain safety and immunogenicity data after a booster dose of Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was compared to similar information obtained after Zoster Vaccine, Live administration to age-matched and younger participants who received their first dose of Zoster Vaccine, Live. The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in participants ≥70 years of age induces an antibody response that is noninferior to that of a first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus (VZV) antibodies.
    Detailed Description
    All participants were followed for one year after completion of the 42-day post-vaccination period while Groups 1 and 2 were followed for a total of three years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Herpes Zoster, Varicella-zoster Vaccine
    Keywords
    Shingles, Vaccine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    600 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1: Booster Dose Participants ≥70 years of age
    Arm Type
    Experimental
    Arm Description
    Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 NCT00007501)
    Arm Title
    Group 2: First Dose Participants ≥70 years of age
    Arm Type
    Experimental
    Arm Description
    Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age
    Arm Title
    Group 3: First Dose Participants ≥60 and <70 years of age
    Arm Type
    Experimental
    Arm Description
    Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live
    Arm Title
    Group 4: First Dose Participants ≥50 and <60 years of age
    Arm Type
    Experimental
    Arm Description
    Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live
    Intervention Type
    Biological
    Intervention Name(s)
    Zoster Vaccine, Live
    Other Intervention Name(s)
    V211, ZOSTAVAX™
    Intervention Description
    Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study
    Primary Outcome Measure Information:
    Title
    Geometric Mean Titer (GMT) of the Antibody Responses to Varicella-Zoster Virus (VZV)
    Description
    VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
    Time Frame
    Day 1 (Baseline) and Week 6 postvaccination
    Title
    Geometric Mean Fold Rise (GMFR) From Day 1 (Baseline) to Week 6 Postvaccination in VZV Antibody Titers
    Description
    VZV antibody titers were determined by gpELISA. The GMFR measures the rise in VZV antibodies from Day 1 (Baseline) to Week 6 postvaccination.
    Time Frame
    Day 1 (Baseline) and Week 6 postvaccination
    Secondary Outcome Measure Information:
    Title
    Number of Participants Reporting One or More Adverse Experiences
    Description
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. A serious adverse experience is any AE that results in death, is life threatening, results in persistent disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention. Vaccine-related AEs were those assessed by the investigator as definitely, probably, or possibly related to vaccine administration. This outcome measure applies only to AEs collected after vaccination in Part 1 of the current study.
    Time Frame
    Up to 42 days postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All Groups: Must not have a fever of ≥100.4° F on the day of vaccination Any underlying chronic illness must be in stable condition History of varicella or residence in a VZV-endemic area for ≥30 years Group 1: 70 years of age or older Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study Group 2: 70 years of age or older Group 3: 60 to 69 years of age Group 4: 50 to 59 years of age Exclusion Criteria: All Groups: History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin Prior history of herpes zoster Pregnant or breast-feeding, or expecting to conceive within the duration of the study Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination Received any other vaccine within 4 weeks prevaccination On immunosuppressive therapy Has known or suspected immune dysfunction Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir. Groups 2, 3, and 4: Has previously received any varicella or zoster vaccine
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    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
    26452397
    Citation
    Levin MJ, Schmader KE, Pang L, Williams-Diaz A, Zerbe G, Canniff J, Johnson MJ, Caldas Y, Cho A, Lang N, Su SC, Parrino J, Popmihajlov Z, Weinberg A. Cellular and Humoral Responses to a Second Dose of Herpes Zoster Vaccine Administered 10 Years After the First Dose Among Older Adults. J Infect Dis. 2016 Jan 1;213(1):14-22. doi: 10.1093/infdis/jiv480. Epub 2015 Oct 9.
    Results Reference
    result
    PubMed Identifier
    30165651
    Citation
    Weinberg A, Popmihajlov Z, Schmader KE, Johnson MJ, Caldas Y, Salazar AT, Canniff J, McCarson BJ, Martin J, Pang L, Levin MJ. Persistence of Varicella-Zoster Virus Cell-Mediated Immunity After the Administration of a Second Dose of Live Herpes Zoster Vaccine. J Infect Dis. 2019 Jan 7;219(2):335-338. doi: 10.1093/infdis/jiy514.
    Results Reference
    derived

    Learn more about this trial

    Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)

    We'll reach out to this number within 24 hrs