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Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2)

Primary Purpose

Staphylococcus Aureus, Bacteremia, Mediastinitis

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
V710
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcus Aureus

Eligibility Criteria

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

Inclusion Criteria:

  • Participant is scheduled to undergo cardiothoracic surgery involving a full median sternotomy (not including cardiac transplantation surgery) within 14 to 60 days after vaccination.
  • Female participants of reproductive potential are required to have a negative urine or serum pregnancy test immediately prior to study vaccination and must use an acceptable form of birth control.

Exclusion Criteria:

  • Participants had an invasive Staphylococcus aureus infection within the past 3 months prior to study entry.
  • A realistic (>50%) possibility that cardiothoracic surgery will be necessary sooner than 10 days after vaccination.
  • Participant is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery.
  • Participant has any type of ventricular-assist device in place at the time of study entry.
  • Participant has a history of anaphylaxis to any of the vaccine components.
  • Participant received V710 vaccine, any other investigational Staphylococcus aureus vaccine, or investigational Staphylococcus aureus antibodies.
  • Participant has a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to study vaccination.
  • Participant has impairment of the immune system.
  • Participant has a medical condition in which the expected survival is less than 90 days.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    V710 60 µg

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection
    Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as ≥1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound.
    Incidence Rate of Vaccine-related Serious Adverse Experiences
    Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention.

    Secondary Outcome Measures

    Number of Participants With Invasive Staphylococcus Aureus Infection
    Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. An invasive Staphylococcus infection included bacteremia, deep sternal wound infection, deep-tissue organ/space infection at another surgical site, or any other deep-tissue infection.
    Number of Participants With Surgical-site Staphylococcus Aureus Infection
    Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. A Staphylococcus infection surgical-site infection included any superficial incisional, deep incisional, or organ/space infection at the sternal site, the vascular harvest (donor) site, or any other site at which the surgery was performed.

    Full Information

    First Posted
    August 17, 2007
    Last Updated
    October 1, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00518687
    Brief Title
    Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2)
    Official Title
    A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine (V710) in Adult Patients Scheduled for Cardiothoracic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    December 2007 (undefined)
    Primary Completion Date
    August 2011 (Actual)
    Study Completion Date
    August 2011 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will assess the efficacy of a single dose of V710 vaccine to prevent serious Staphylococcus aureus infections following elective cardiothoracic surgery. The study will also evaluate the immune response and general safety of the V710 vaccine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Staphylococcus Aureus, Bacteremia, Mediastinitis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    8031 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    V710 60 µg
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    V710
    Other Intervention Name(s)
    Merck 0657nI Staphylococcus aureus vaccine
    Intervention Description
    0.5-mL single injection of V710 (60 µg)
    Intervention Type
    Biological
    Intervention Name(s)
    Placebo
    Intervention Description
    0.5-mL single injection of matching placebo
    Primary Outcome Measure Information:
    Title
    Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection
    Description
    Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as ≥1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound.
    Time Frame
    Up to 90 days after surgery
    Title
    Incidence Rate of Vaccine-related Serious Adverse Experiences
    Description
    Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention.
    Time Frame
    Up to 360 days after surgery
    Secondary Outcome Measure Information:
    Title
    Number of Participants With Invasive Staphylococcus Aureus Infection
    Description
    Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. An invasive Staphylococcus infection included bacteremia, deep sternal wound infection, deep-tissue organ/space infection at another surgical site, or any other deep-tissue infection.
    Time Frame
    Up to 90 days after surgery
    Title
    Number of Participants With Surgical-site Staphylococcus Aureus Infection
    Description
    Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. A Staphylococcus infection surgical-site infection included any superficial incisional, deep incisional, or organ/space infection at the sternal site, the vascular harvest (donor) site, or any other site at which the surgery was performed.
    Time Frame
    Up to 90 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participant is scheduled to undergo cardiothoracic surgery involving a full median sternotomy (not including cardiac transplantation surgery) within 14 to 60 days after vaccination. Female participants of reproductive potential are required to have a negative urine or serum pregnancy test immediately prior to study vaccination and must use an acceptable form of birth control. Exclusion Criteria: Participants had an invasive Staphylococcus aureus infection within the past 3 months prior to study entry. A realistic (>50%) possibility that cardiothoracic surgery will be necessary sooner than 10 days after vaccination. Participant is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery. Participant has any type of ventricular-assist device in place at the time of study entry. Participant has a history of anaphylaxis to any of the vaccine components. Participant received V710 vaccine, any other investigational Staphylococcus aureus vaccine, or investigational Staphylococcus aureus antibodies. Participant has a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to study vaccination. Participant has impairment of the immune system. Participant has a medical condition in which the expected survival is less than 90 days.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23549582
    Citation
    Fowler VG, Allen KB, Moreira ED, Moustafa M, Isgro F, Boucher HW, Corey GR, Carmeli Y, Betts R, Hartzel JS, Chan IS, McNeely TB, Kartsonis NA, Guris D, Onorato MT, Smugar SS, DiNubile MJ, Sobanjo-ter Meulen A. Effect of an investigational vaccine for preventing Staphylococcus aureus infections after cardiothoracic surgery: a randomized trial. JAMA. 2013 Apr 3;309(13):1368-78. doi: 10.1001/jama.2013.3010.
    Results Reference
    derived

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    Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2)

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