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Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002)

Primary Purpose

Staphylococcal Infections

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
V710 (30 µg) with MAA
V710 (30 µg) without MAA
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcal Infections focused on measuring Bacterial Vaccines, Staphylococcus Aureus, Adjuvanted Vaccine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Participant was in good physical health
  • Participant was able to understand study procedures and agreed to participate in the study by providing written informed consent.
  • Participant was willing and able to participate in the entire study duration planned for up to 12 months (~360 days).
  • Female participants of reproductive potential were required to have a negative urine pregnancy test immediately prior to study vaccination. Female participants of reproductive potential must have used an acceptable method of birth control for 2 weeks prior to enrollment, and agreed to use an acceptable method of birth control for 1 month after vaccination.

Exclusion criteria:

  • Participant suffered from a chronic skin condition that predisposed the individual to the development of chronic skin or soft-tissue infections (e.g., psoriasis, chronic granulomatous disease, atopic dermatitis).
  • Participant developed a serious infection (e.g., bacteremia, pneumonia, mediastinitis) attributed to S. aureus in the 12 months prior to screening.
  • Participant had a history of anaphylaxis to aluminum-containing adjuvant or other vaccine components.
  • Participant had a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to receipt of V710.
  • Participant had received a live virus vaccine within 30 days prior to receipt of V710 or was scheduled to receive vaccination with a live virus vaccine within 30 days following study entry.
  • Participant had received any other licensed vaccine (including non-live virus vaccines) within 14 days prior to receipt of V710 or was scheduled to receive any other licensed vaccine (including non-live virus vaccines) within 30 days following study entry.
  • Participant had received V710 in a prior clinical study (Merck V710 Protocol 001).
  • Participant was administered immunoglobulin or blood product within 90 days prior to receipt of V710 or was scheduled to receive such products within 30 days following study entry.
  • Participant had received treatment with systemic (intramuscular, oral, or intravenous) corticosteroids or another immunosuppressive medication (e.g., calcineurin inhibitors, mycophenolate, azathioprine) or biological agents (e.g., rituximab) in the 14 days prior to receipt of V710 or was anticipated to receive such medications for a chronic medical condition during the course of the study.
  • Participant had a condition that required active medical intervention or monitoring to avert serious danger to the participant's health or well-being, such as diabetes mellitus, autoimmune disease, or clinically significant chronic medical conditions that were considered progressive, including but not limited to: coronary artery disease, congestive heart failure, cardiomyopathy, progressive valvular heart disease, chronic obstructive pulmonary disease, pulmonary fibrosis, active peptic ulcer disease, chronic renal disease, chronic hepatic disease, multiple sclerosis, progressive neuropathies, or seizure disorder requiring therapy in the past 3 years.
  • Participant had known or suspected impairment of immunologic function including, but not limited to, the following conditions: autoimmune disease, diabetes mellitus, endstage renal disease, hepatic insufficiency/cirrhosis, splenectomy, or human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS).
  • Participant had a condition in which repeated venipuncture or injections posed more than minimal risk for the subject, such as hemophilia, other severe coagulation disorders, or significantly impaired venous access.
  • Participant was pregnant or breastfeeding, or planning to conceive within the 12-month study duration period.
  • Participant had clinically significant abnormalities based on the participant or physical examination.
  • Participant had recent history (within the past 5 years) or current evidence of drug or alcohol abuse.
  • Participant had a major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or any subject with suicidal ideation within the previous 3 years.
  • Participant was legally or mentally incapacitated.
  • Participant had participated in another clinical study in the past 4 weeks, or participant planned to participate in a treatment-based study or study in which an invasive procedure was to be performed during the first 3 months of this study (through Day 84).
  • Participant had a history of any condition which, in the opinion of the investigator, posed an additional risk for the subject or confounded the results of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    V710 without MAA

    V710 with MAA

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of Participants With a Positive Immune Response, Defined as a Change in Antibody Level Greater Than or Equal to a 2-fold-rise at Day 14 Compared to Baseline
    Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
    Geometric Mean Antibody Concentrations (GMC)
    Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
    Change in Antibody Concentration (Titer) at Day 14 Compared to Baseline, Expressed as the Geometric Mean Fold-rise (GMFR)
    Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay. The GMFR is the ratio of the antibody concentration at Day 14 to the antibody concentration at baseline.
    Number of Vaccine-related Serious Adverse Experiences
    Investigators were instructed to determine the seriousness and causality (relatedness to test vaccine) of each AE based on criteria defined in the protocol: A serious adverse event (SAE) is any AE 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, is a cancer, is an overdose, or is another important medical event that may require medical or surgical intervention to prevent one of the outcomes listed above.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2011
    Last Updated
    March 23, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01324440
    Brief Title
    Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002)
    Official Title
    A Randomized, Multicenter, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With Merck Aluminum Adjuvant or Without Merck Aluminum Adjuvant in Healthy Adults 18 to 70 Years of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    October 2007 (Actual)
    Study Completion Date
    October 2007 (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 evaluate the safety, tolerability, and immunogenicity of the Merck 0657nI S. aureus vaccine (V710) either with or without Merck Aluminum Adjuvant (MAA).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Staphylococcal Infections
    Keywords
    Bacterial Vaccines, Staphylococcus Aureus, Adjuvanted Vaccine

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    V710 without MAA
    Arm Type
    Experimental
    Arm Title
    V710 with MAA
    Arm Type
    Active Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    V710 (30 µg) with MAA
    Intervention Description
    Single 0.5-mL injection (30-µg) of V710 with MAA, intramuscularly
    Intervention Type
    Biological
    Intervention Name(s)
    V710 (30 µg) without MAA
    Intervention Description
    Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly
    Primary Outcome Measure Information:
    Title
    Number of Participants With a Positive Immune Response, Defined as a Change in Antibody Level Greater Than or Equal to a 2-fold-rise at Day 14 Compared to Baseline
    Description
    Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
    Time Frame
    Baseline and Day 14 postvaccination
    Title
    Geometric Mean Antibody Concentrations (GMC)
    Description
    Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay.
    Time Frame
    Day 14 postvaccination
    Title
    Change in Antibody Concentration (Titer) at Day 14 Compared to Baseline, Expressed as the Geometric Mean Fold-rise (GMFR)
    Description
    Immunoglobulin G (IgG) antibodies were measured by a LUMINEX(TM) assay. The GMFR is the ratio of the antibody concentration at Day 14 to the antibody concentration at baseline.
    Time Frame
    Baseline and Day 14 postvaccination
    Title
    Number of Vaccine-related Serious Adverse Experiences
    Description
    Investigators were instructed to determine the seriousness and causality (relatedness to test vaccine) of each AE based on criteria defined in the protocol: A serious adverse event (SAE) is any AE 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, is a cancer, is an overdose, or is another important medical event that may require medical or surgical intervention to prevent one of the outcomes listed above.
    Time Frame
    Up to Day 360 postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: Participant was in good physical health Participant was able to understand study procedures and agreed to participate in the study by providing written informed consent. Participant was willing and able to participate in the entire study duration planned for up to 12 months (~360 days). Female participants of reproductive potential were required to have a negative urine pregnancy test immediately prior to study vaccination. Female participants of reproductive potential must have used an acceptable method of birth control for 2 weeks prior to enrollment, and agreed to use an acceptable method of birth control for 1 month after vaccination. Exclusion criteria: Participant suffered from a chronic skin condition that predisposed the individual to the development of chronic skin or soft-tissue infections (e.g., psoriasis, chronic granulomatous disease, atopic dermatitis). Participant developed a serious infection (e.g., bacteremia, pneumonia, mediastinitis) attributed to S. aureus in the 12 months prior to screening. Participant had a history of anaphylaxis to aluminum-containing adjuvant or other vaccine components. Participant had a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to receipt of V710. Participant had received a live virus vaccine within 30 days prior to receipt of V710 or was scheduled to receive vaccination with a live virus vaccine within 30 days following study entry. Participant had received any other licensed vaccine (including non-live virus vaccines) within 14 days prior to receipt of V710 or was scheduled to receive any other licensed vaccine (including non-live virus vaccines) within 30 days following study entry. Participant had received V710 in a prior clinical study (Merck V710 Protocol 001). Participant was administered immunoglobulin or blood product within 90 days prior to receipt of V710 or was scheduled to receive such products within 30 days following study entry. Participant had received treatment with systemic (intramuscular, oral, or intravenous) corticosteroids or another immunosuppressive medication (e.g., calcineurin inhibitors, mycophenolate, azathioprine) or biological agents (e.g., rituximab) in the 14 days prior to receipt of V710 or was anticipated to receive such medications for a chronic medical condition during the course of the study. Participant had a condition that required active medical intervention or monitoring to avert serious danger to the participant's health or well-being, such as diabetes mellitus, autoimmune disease, or clinically significant chronic medical conditions that were considered progressive, including but not limited to: coronary artery disease, congestive heart failure, cardiomyopathy, progressive valvular heart disease, chronic obstructive pulmonary disease, pulmonary fibrosis, active peptic ulcer disease, chronic renal disease, chronic hepatic disease, multiple sclerosis, progressive neuropathies, or seizure disorder requiring therapy in the past 3 years. Participant had known or suspected impairment of immunologic function including, but not limited to, the following conditions: autoimmune disease, diabetes mellitus, endstage renal disease, hepatic insufficiency/cirrhosis, splenectomy, or human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS). Participant had a condition in which repeated venipuncture or injections posed more than minimal risk for the subject, such as hemophilia, other severe coagulation disorders, or significantly impaired venous access. Participant was pregnant or breastfeeding, or planning to conceive within the 12-month study duration period. Participant had clinically significant abnormalities based on the participant or physical examination. Participant had recent history (within the past 5 years) or current evidence of drug or alcohol abuse. Participant had a major psychiatric illness, including any history of schizophrenia or severe psychosis, bipolar disorder requiring therapy, or any subject with suicidal ideation within the previous 3 years. Participant was legally or mentally incapacitated. Participant had participated in another clinical study in the past 4 weeks, or participant planned to participate in a treatment-based study or study in which an invasive procedure was to be performed during the first 3 months of this study (through Day 84). Participant had a history of any condition which, in the opinion of the investigator, posed an additional risk for the subject or confounded the results of the study.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22192849
    Citation
    Harro CD, Betts RF, Hartzel JS, Onorato MT, Lipka J, Smugar SS, Kartsonis NA. The immunogenicity and safety of different formulations of a novel Staphylococcus aureus vaccine (V710): results of two Phase I studies. Vaccine. 2012 Feb 21;30(9):1729-36. doi: 10.1016/j.vaccine.2011.12.045. Epub 2011 Dec 20.
    Results Reference
    result

    Learn more about this trial

    Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002)

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