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A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)

Primary Purpose

Herpes Zoster

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous
ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous
ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal
ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal
Full Dose Intradermal Placebo
Intradermal 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

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

Inclusion Criteria:

  • Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years
  • Temperature less than 100.4 °F on day of vaccination
  • Female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination
  • In good health

Exclusion Criteria:

  • History of hypersensitivity reaction to any vaccine component, including gelatin or neomycin
  • Household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals
  • Household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella
  • Prior history of herpes zoster
  • Prior receipt of any varicella or zoster vaccine
  • Received or is expected to receive immune globulin and/or blood products from 5 months prior to randomization through 42 days after vaccination
  • On immunosuppressive therapy
  • Known or suspected immune dysfunction
  • Received a live virus vaccine or is scheduled to receive a live virus vaccine from 4 weeks prior to study vaccination through the completion of all study visits
  • Received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days prior to study vaccination through 7 days postvaccination, except for inactivated influenza vaccine
  • Not ambulatory
  • Pregnant or breastfeeding
  • Use of nontopical antiviral therapy with activity against herpes viruses
  • Active untreated tuberculosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Full Dose Subcutaneous

    1/3 Dose Subcutaneous

    Full Dose Intradermal

    1/3 Dose Intradermal

    1/10 Dose Intradermal

    1/27 Dose Intradermal

    Arm Description

    Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.

    Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.

    Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.

    Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.

    Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.

    Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.

    Outcomes

    Primary Outcome Measures

    Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies
    VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.
    Number of Participants Reporting an Adverse Experience (AE)
    An 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.
    Number of Participants Reporting a Serious Adverse Experience (SAE)
    An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.
    Number of Participants Reporting a Serious Adverse Experience
    An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention
    Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
    The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.
    Number of Participants Reporting Systemic Adverse Experiences
    Systemic AEs included all reported AEs except injection-site AEs
    Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)
    Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.

    Secondary Outcome Measures

    Full Information

    First Posted
    June 28, 2011
    Last Updated
    May 19, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01385566
    Brief Title
    A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
    Official Title
    A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.
    Detailed Description
    This is an exploratory, randomized, partially blinded, multicenter clinical study designed to compare safety and biomarkers of varicella zoster virus immunogenicity when administering ZOSTAVAX™ (V211) at various doses both intradermally and subcutaneously in healthy male and female participants 50 years of age and older.

    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 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    223 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Full Dose Subcutaneous
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
    Arm Title
    1/3 Dose Subcutaneous
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
    Arm Title
    Full Dose Intradermal
    Arm Type
    Experimental
    Arm Description
    Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
    Arm Title
    1/3 Dose Intradermal
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
    Arm Title
    1/10 Dose Intradermal
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
    Arm Title
    1/27 Dose Intradermal
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
    Intervention Type
    Biological
    Intervention Name(s)
    ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous
    Other Intervention Name(s)
    V211
    Intervention Description
    One 0.65 mL injection subcutaneously on Day 1
    Intervention Type
    Biological
    Intervention Name(s)
    ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous
    Other Intervention Name(s)
    V211
    Intervention Description
    One approximately 0.22 mL injection subcutaneously on Day 1
    Intervention Type
    Biological
    Intervention Name(s)
    ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal
    Other Intervention Name(s)
    V211
    Intervention Description
    Two intradermal injections of approximately 0.15 mL each on Day 1
    Intervention Type
    Biological
    Intervention Name(s)
    ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal
    Other Intervention Name(s)
    V211
    Intervention Description
    One intradermal injection of approximately 0.1 mL on Day 1
    Intervention Type
    Biological
    Intervention Name(s)
    Full Dose Intradermal Placebo
    Intervention Description
    Two intradermal placebo injections of approximately 0.15 mL each on Day 1
    Intervention Type
    Biological
    Intervention Name(s)
    Intradermal Placebo
    Intervention Description
    One intradermal placebo injection of approximately 0.1 mL on Day 1
    Primary Outcome Measure Information:
    Title
    Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies
    Description
    VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.
    Time Frame
    Baseline and 6 weeks following vaccine administration
    Title
    Number of Participants Reporting an Adverse Experience (AE)
    Description
    An 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.
    Time Frame
    Up to 42 days following vaccine administration
    Title
    Number of Participants Reporting a Serious Adverse Experience (SAE)
    Description
    An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.
    Time Frame
    Up to 42 days following vaccine administration
    Title
    Number of Participants Reporting a Serious Adverse Experience
    Description
    An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention
    Time Frame
    Within 5 days after the blood draw at approximately 20 months following vaccine administration
    Title
    Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
    Description
    The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.
    Time Frame
    Up to 5 days following vaccine administration
    Title
    Number of Participants Reporting Systemic Adverse Experiences
    Description
    Systemic AEs included all reported AEs except injection-site AEs
    Time Frame
    Up to 42 days following vaccine administration
    Title
    Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)
    Description
    Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.
    Time Frame
    Up to 42 days following vaccine administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years Temperature less than 100.4 °F on day of vaccination Female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination In good health Exclusion Criteria: History of hypersensitivity reaction to any vaccine component, including gelatin or neomycin Household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals Household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella Prior history of herpes zoster Prior receipt of any varicella or zoster vaccine Received or is expected to receive immune globulin and/or blood products from 5 months prior to randomization through 42 days after vaccination On immunosuppressive therapy Known or suspected immune dysfunction Received a live virus vaccine or is scheduled to receive a live virus vaccine from 4 weeks prior to study vaccination through the completion of all study visits Received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days prior to study vaccination through 7 days postvaccination, except for inactivated influenza vaccine Not ambulatory Pregnant or breastfeeding Use of nontopical antiviral therapy with activity against herpes viruses Active untreated tuberculosis

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27061887
    Citation
    Beals CR, Railkar RA, Schaeffer AK, Levin Y, Kochba E, Meyer BK, Evans RK, Sheldon EA, Lasseter K, Lang N, Weinberg A, Canniff J, Levin MJ. Immune response and reactogenicity of intradermal administration versus subcutaneous administration of varicella-zoster virus vaccine: an exploratory, randomised, partly blinded trial. Lancet Infect Dis. 2016 Aug;16(8):915-22. doi: 10.1016/S1473-3099(16)00133-X. Epub 2016 Apr 6.
    Results Reference
    result

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    A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)

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