search
Back to results

A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)

Primary Purpose

Herpes Zoster

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Comparator: V212
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 focused on measuring Herpes Zoster (Shingles)

Eligibility Criteria

50 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must be 50 to 59 years of age
  • No fever on vaccination days
  • Must have had chickenpox or lived in an area where the chickenpox virus is prevalent for 30 or more years
  • Females of child-bearing potential must use acceptable forms of birth control

Exclusion Criteria:

  • Prior history of shingles
  • Prior receipt of any chickenpox or shingles vaccine
  • Pregnant or breastfeeding
  • Received or expect to receive a live virus vaccine (such as measles, mumps, rubella) from 4 weeks before the first visit through the last visit
  • Received or expect to receive an inactivated vaccine (such as tetanus or pneumonia) from 7 days before the first visit through the last visit
  • Received immunoglobulin or blood products
  • Receiving treatment that may weaken the immune system
  • Have an immune system disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine

    Part 1: Gamma- Irradiated VZV Vaccine A

    Part 1: Placebo

    Part 2: Gamma- Irradiated VZV Vaccine B

    Part 2: Gamma- Irradiated VZV Vaccine C

    Arm Description

    Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine A; 4-dose regimen administered ~30 days apart.

    Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered ~30 days apart.

    Participants received a 4-dose placebo regimen administered ~30 days apart.

    Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered ~30 days apart.

    Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered ~30 days apart.

    Outcomes

    Primary Outcome Measures

    Part 1: Geometric Mean Fold Rise of the Varicella-Zoster Virus (VZV)-Specific Immune Responses Measured by Glycoprotein Enzyme-Linked Immunosorbent Assay in Gamma-Irradiated VZV Vaccine A Recipients
    Serum samples were tested for antibody response using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) in gamma-irradiated VZV vaccine A recipients. The geometric mean fold rise (GMFR) is the response at approximately 28 days postdose 4 / response predose on Day 1. This outcome measure applied only to participants who received VZV vaccine A; heat-treated VZV vaccine and placebo participants were not assessed for this outcome.
    Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine B Recipients
    Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine B recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1.
    Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine C Recipients
    Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine C recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1.
    Percentage of Participants With a Serious Adverse Event
    A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, or is a congenital anomaly or birth defect. The percentage of participants with one or more SAEs was assessed.
    Percentage of Participants With an Injection-Site Adverse Event Prompted on the Vaccination Report Card
    An adverse event (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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Vaccination Report Card (VRC)-prompted injection-site AEs included redness, swelling, and pain/tenderness/soreness. The percentage of participants with one or more VRC prompted injection-site AE was assessed with incidence > 0% in one or more vaccination groups.
    Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card
    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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. VRC-prompted systemic AEs included non-injection-site varicella-like and herpes zoster (HZ)-like rashes. The percentage of participants with one or more VRC-prompted systemic AE was assessed with incidence > 0% in one or more vaccination groups.
    Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card
    Elevated temperature is defined as ≥100.5 °F (≥38.1 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed.
    Percentage of Participants Who Discontinued the Study Drug Due to an Adverse Event
    An adverse event (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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who discontinued the study drug due to one or more AEs was assessed.

    Secondary Outcome Measures

    Part 1: Geometric Mean Fold Rise of the Heat-Treated VZV-Specific Immune Responses Measured by gpELISA
    Serum samples were tested for antibody response using gpELISA in heat-treated VZV vaccine recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1.

    Full Information

    First Posted
    June 11, 2008
    Last Updated
    October 18, 2019
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00696709
    Brief Title
    A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)
    Official Title
    A Phase I, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 12, 2008 (Actual)
    Primary Completion Date
    November 16, 2009 (Actual)
    Study Completion Date
    November 16, 2009 (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
    The purpose of this study was to assess the safety and tolerability of gamma-irradiated varicella-zoster virus (VZV) vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) and to determine if they were immunogenic when administered to healthy individuals, as measured by VZV-specific antibody responses by glycoprotein enzyme-linked immunosorbent assay (gpELISA). The primary hypothesis was that gamma-irradiated VZV vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) would elicit an acceptable VZV-specific immune response. The secondary hypothesis for Part 1 of the study was that heat-treated VZV vaccine would elicit an acceptable VZV-specific immune response.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Herpes Zoster
    Keywords
    Herpes Zoster (Shingles)

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    290 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1: Heat-treated Varicella-Zoster Virus (VZV) Vaccine
    Arm Type
    Experimental
    Arm Description
    Participants received an 0.65 mL subcutaneous injection of heat-treated varicella zoster virus (VZV) vaccine A; 4-dose regimen administered ~30 days apart.
    Arm Title
    Part 1: Gamma- Irradiated VZV Vaccine A
    Arm Type
    Experimental
    Arm Description
    Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine A; 4-dose regimen administered ~30 days apart.
    Arm Title
    Part 1: Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants received a 4-dose placebo regimen administered ~30 days apart.
    Arm Title
    Part 2: Gamma- Irradiated VZV Vaccine B
    Arm Type
    Experimental
    Arm Description
    Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine B; 4-dose regimen administered ~30 days apart.
    Arm Title
    Part 2: Gamma- Irradiated VZV Vaccine C
    Arm Type
    Experimental
    Arm Description
    Participants received an 0.65 mL subcutaneous injection of alternative inactivation method VZV vaccine C; 4-dose regimen administered ~30 days apart.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: V212
    Intervention Description
    0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Placebo
    Intervention Description
    Placebo; 4-dose regimen administered ~30 days apart.
    Primary Outcome Measure Information:
    Title
    Part 1: Geometric Mean Fold Rise of the Varicella-Zoster Virus (VZV)-Specific Immune Responses Measured by Glycoprotein Enzyme-Linked Immunosorbent Assay in Gamma-Irradiated VZV Vaccine A Recipients
    Description
    Serum samples were tested for antibody response using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) in gamma-irradiated VZV vaccine A recipients. The geometric mean fold rise (GMFR) is the response at approximately 28 days postdose 4 / response predose on Day 1. This outcome measure applied only to participants who received VZV vaccine A; heat-treated VZV vaccine and placebo participants were not assessed for this outcome.
    Time Frame
    Baseline and ~28 days Postdose 4 (~Day 118)
    Title
    Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine B Recipients
    Description
    Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine B recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1.
    Time Frame
    Baseline and ~28 days Postdose 4 (~Day 118)
    Title
    Part 2: Geometric Mean Fold Rise of the VZV-Specific Immune Responses Measured by gpELISA in Gamma-Irradiated VZV Vaccine C Recipients
    Description
    Serum samples were tested for antibody response using gpELISA in gamma-irradiated VZV vaccine C recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1.
    Time Frame
    Baseline and ~28 days Postdose 4 (~Day 118)
    Title
    Percentage of Participants With a Serious Adverse Event
    Description
    A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, or is a congenital anomaly or birth defect. The percentage of participants with one or more SAEs was assessed.
    Time Frame
    Up to ~28 days Postdose 4 (Up to ~118 days)
    Title
    Percentage of Participants With an Injection-Site Adverse Event Prompted on the Vaccination Report Card
    Description
    An adverse event (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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Vaccination Report Card (VRC)-prompted injection-site AEs included redness, swelling, and pain/tenderness/soreness. The percentage of participants with one or more VRC prompted injection-site AE was assessed with incidence > 0% in one or more vaccination groups.
    Time Frame
    Up to Day 5 post any vaccination (Up to ~5 days)
    Title
    Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card
    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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. VRC-prompted systemic AEs included non-injection-site varicella-like and herpes zoster (HZ)-like rashes. The percentage of participants with one or more VRC-prompted systemic AE was assessed with incidence > 0% in one or more vaccination groups.
    Time Frame
    Up to ~28 days Postdose 4 (Up to ~118 days)
    Title
    Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card
    Description
    Elevated temperature is defined as ≥100.5 °F (≥38.1 °C), oral equivalent. The percentage of participants with VRC-prompted elevated temperature was assessed.
    Time Frame
    Up to ~28 days Postdose 4 (Up to ~118 days)
    Title
    Percentage of Participants Who Discontinued the Study Drug Due to an Adverse Event
    Description
    An adverse event (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 study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. The percentage of participants who discontinued the study drug due to one or more AEs was assessed.
    Time Frame
    Up to Dose 4 (Up to ~90 days)
    Secondary Outcome Measure Information:
    Title
    Part 1: Geometric Mean Fold Rise of the Heat-Treated VZV-Specific Immune Responses Measured by gpELISA
    Description
    Serum samples were tested for antibody response using gpELISA in heat-treated VZV vaccine recipients. The GMFR is the response at approximately 28 days postdose 4 / response predose on Day 1.
    Time Frame
    Baseline and ~28 days Postdose 4 (~Day 118)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Must be 50 to 59 years of age No fever on vaccination days Must have had chickenpox or lived in an area where the chickenpox virus is prevalent for 30 or more years Females of child-bearing potential must use acceptable forms of birth control Exclusion Criteria: Prior history of shingles Prior receipt of any chickenpox or shingles vaccine Pregnant or breastfeeding Received or expect to receive a live virus vaccine (such as measles, mumps, rubella) from 4 weeks before the first visit through the last visit Received or expect to receive an inactivated vaccine (such as tetanus or pneumonia) from 7 days before the first visit through the last visit Received immunoglobulin or blood products Receiving treatment that may weaken the immune system Have an immune system disorder
    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

    Learn more about this trial

    A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)

    We'll reach out to this number within 24 hrs