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Vaccine Treatment for Ebola Virus in Healthy Adults (V920-001)

Primary Purpose

Ebola Virus

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
V920
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ebola Virus

Eligibility Criteria

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

Inclusion Criteria:

  • Healthy adult male or non-pregnant, non-lactating female, ages 18 to 50 (inclusive) at the time of screening
  • Have provided written informed consent before screening
  • Free of clinically significant health problems, as determined by pertinent medical history and clinical examination prior to entry into the study
  • Available, able, and willing to participate for all study visits and procedures
  • Males and females who are willing to practice abstinence from sexual intercourse, or willing to use effective methods of contraception, from at least 30 days prior to vaccination until study end.
  • Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination
  • Score at least 80% on the Comprehension Assessment test

Exclusion Criteria:

  • History of prior infection with a filovirus or prior participation in a filovirus vaccine trial
  • History of prior infection with VSV or receipt of a VSV vectored vaccine
  • Is a healthcare worker who has direct contact with patients
  • Has a house-hold contact (HHC) who is immunodeficient, Human Immunodeficiency Virus (HIV)-positive, pregnant, has an unstable medical condition, or is under the age of 5 years
  • Is a childcare worker who has direct contact with children 5 years of age or younger
  • Directly prepares food in the food industry
  • History of employment in an industry involved in contact with ruminant animals, veterinary sciences, or other potential exposure to VSV
  • Planned or frequent contact with animals at-risk of VSV infection (e.g. cattle, horses, pigs, mules, etc.)
  • History of employment or activity which involves potential contact with filoviruses
  • History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
  • Known allergy to the components of the BPSC1001 vaccine product
  • Receipt of investigational product up to 30 days prior to enrollment or ongoing participation in another clinical trial
  • Receipt of licensed vaccines within 30 days of planned study immunization
  • Ongoing participation in another clinical trial
  • Ability to observe possible local reactions at the eligible injections sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
  • Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, electrocardiogram, and/or laboratory screening test. This would include a known hemoglobinopathy or coagulation abnormality.
  • Any baseline laboratory screening tests which is outside of acceptable range as defined in the protocol.: alanine aminotransferase, aspartate aminotransferase, creatinine, hemoglobin, platelet count, total white blood cell count, urine protein, urine occult blood, urine glucose
  • Any serologic evidence of hepatitis B or C infection
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, cytotoxic therapy in the previous 5 years, and/or diabetes
  • Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, excluding a single febrile seizure as a child
  • Have an active malignancy or history of metastatic or hematologic malignancy
  • Suspected or known alcohol and/or illicit drug abuse within the past 5 years
  • Moderate or severe illness and/or fever >100.4F within one week prior to vaccination
  • Pregnant or lactating female, or female who intends to become pregnant during the study period
  • Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
  • History of blood donation within 60 days of enrollment or plans to donate within the study period
  • Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of study entry. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day, Intranasal and topical steroids are allowed)
  • Unwilling to allow storage and use of blood for future vaccine research
  • Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    3x10^6 plaque-forming units (pfu) Vaccine Cohort

    2x10^7 pfu Vaccine Cohort

    1x10^8 pfu Vaccine Cohort

    Placebo Cohort

    Arm Description

    Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.

    Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.

    Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.

    Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.

    Outcomes

    Primary Outcome Measures

    Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE)
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event (TEAE) is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). The number of participants that experienced at least one solicited local TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.
    Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE) by Severity
    An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A TEAE is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA's Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials": Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least one solicited local TEAE was summarized by grade. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.
    Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE)
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Systemic reactogenicity signs and symptoms include pyrexia (subjective and objective fever), chills, hyperhidrosis (sweats), myalgia, arthralgia, fatigue, headache, and gastrointestinal symptoms including nausea, vomiting, abdominal pain, and/or diarrhea. The number of participants that experienced at least one solicited systemic TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.
    Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE) by Severity
    An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A TEAE is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Systemic reactogenicity signs and symptoms include pyrexia (subjective and objective fever), chills, hyperhidrosis (sweats), myalgia, arthralgia, fatigue, headache, and gastrointestinal symptoms including nausea, vomiting, abdominal pain, and/or diarrhea. AEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least 1 solicited systemic TEAE was summarized by grade. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.
    Number of Participants With One or More Unsolicited Treatment-Emergent Adverse Events (TEAE)
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. The number of participants that experienced at least one unsolicited TEAE was assessed. Unsolicited AEs occurred from the time of injection through 28 days following injection.
    Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE)
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. A related TEAE is defined as a TEAE that was possibly, probably, or definitely related to the vaccination as assessed by the investigator. The number of participants that experienced at least one unsolicited TEAE related to study vaccination was assessed.
    Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE) by Severity
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. A related TEAE is defined as a TEAE that was possibly, probably, or definitely related to the vaccination as assessed by the investigator. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA's Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials": Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least one unsolicited TEAE related to study vaccination was summarized by grade.
    Number of Participants With Early Study Discontinuation Due to an Adverse Event
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. The number of participants prematurely withdrawing from the study due to an AE was assessed.
    Number of Participants With One or More Serious Adverse Event
    An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The number of participants that experienced one or more SAE was summarized.

    Secondary Outcome Measures

    Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies
    The Geometric Mean Titers (GMT) of ZEBOV-specific Immunoglobulin G antibodies were measured by unqualified ZEBOV immunoglobulin (IgG) enzyme-linked immunosorbent assay (ELISA). For titers expressed in ELISA Units/mL, the lower level of quantitation (LLOQ) was 58.84. ZEBOV IgG titers at baseline (Day 0) and analysis Days 7, 14, 28, 56, 84, and 180 were summarized by V920 vaccine dose level and placebo as the mean of log10 titers, transformed into GMT. The geometric standard deviation (GSD) for the GMT at each visit was obtained by exponentiating the standard deviation for the mean of log (base 10) transformed titers.
    Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies
    The Geometric Mean Titers (GMT) of ZEBOV-specific neutralizing antibodies were measured by pseudovirion neutralization assays (PsVNA). Titers were reported for PsVNA50 values which were derived from the reciprocal of the dilution that resulted in a 50% decrease in luciferase activity. The LLOQ for the PsVNA was 20. If the PsVNA was reported ≤20, the numeric portion of the titer was divided by 2 for statistical purposes, which could result in a reported GMT <20.0. PsVNA50 titers at baseline (Day 0) and analysis Days 7, 14, 28, 56, and 180 were summarized by V920 vaccine dose level and placebo as the mean of log10 titers, transformed into GMT. The geometric standard deviation (GSD) for the GMT at each visit was obtained by exponentiating the standard deviation for the mean of log (base 10) transformed titers.
    Number of Participants With Vaccine Viremia
    The number of participants with viremia detected by recombinant vesicular stomatitis virus (rVSV) reverse transcription polymerase chain reaction (PCR) of blood specimens was assessed.
    Number of Participants With Vaccine Shedding/Excretion in Saliva or Urine
    The number of participants with viremia detected by rVSV reverse transcription PCR of saliva or urine specimens was assessed.
    Mean Copy Number of Vector RNA (Vector Viremia)
    Although the protocol specified a secondary endpoint that included the mean copy number of vector RNA (vector viremia), the Polymerase Chain Reaction (PCR) test used for the study reported a qualitative rather than a quantitative outcome, so the proportion of participants with viremia is reported instead of the mean copy number of vector RNA. Qualitative results are therefore reported in Outcome Measures 12 and 13.

    Full Information

    First Posted
    October 10, 2014
    Last Updated
    October 21, 2019
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    BioProtection Systems Corporation, United States Department of Defense
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02269423
    Brief Title
    Vaccine Treatment for Ebola Virus in Healthy Adults (V920-001)
    Official Title
    A Phase 1 Randomized, Single-Center, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the BPSC-1001 (VSVΔG-ZEBOV) Ebola Virus Vaccine Candidate in Healthy Adult Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 13, 2014 (Actual)
    Primary Completion Date
    August 25, 2015 (Actual)
    Study Completion Date
    August 25, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    BioProtection Systems Corporation, United States Department of Defense

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (Zaire ebolavirus) also known as V920 and BPSC-1001. The purpose of this study is to test how safe the vaccine is in humans and how well it makes the human immune system cause an immune- or defense-response to Ebola virus. This vaccine will be studied at different doses.
    Detailed Description
    This study is being conducted to assess whether this vaccine is safe, and if it causes the body to create an infection-fighting response. Between 1994 and the present, there have been many Ebola virus outbreaks caused by 4 different strains of the virus, affecting mostly people living in central Africa and the health care providers trying to treat them. Ebola viruses are members of the filoviridae virus family, which also includes the dangerous Marburg virus. Ebola virus causes severe and often deadly infection called a viral hemorrhagic fever, characterized by organ failure, bleeding, and death. To date, the virus is found primarily in Central and West Africa. It is not clear where these viruses come from, but it is thought that bats are the most likely source of the human outbreaks that occur. Once an outbreak occurs, the virus is spread from person to person through direct contact with infected blood or body fluids with an infected individual. Given the recent increase in Ebola virus infections occurring in Africa, there is interest in making an effective vaccine to protect against the infection. V920/BPSC-1001 is an experimental Ebola vaccine candidate demonstrating protection against Ebola virus in animal experiments. This is a Phase 1 study to evaluate a novel vaccine to Ebola using a live VSV replacing the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Zaire strain of Ebola (VSVΔG-ZEBOV also known as V920 and BPSC-1001). This phase 1 protocol provides a first-in-human study to evaluate the safety and toxicity of V920/BPSC-1001 in healthy adult participants. Participants will be randomized to receive V920/BPSC-1001 or Placebo by intramuscular injection. Three dose levels will be assessed with follow-up visits through 180 days after the injection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ebola Virus

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    3x10^6 plaque-forming units (pfu) Vaccine Cohort
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
    Arm Title
    2x10^7 pfu Vaccine Cohort
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
    Arm Title
    1x10^8 pfu Vaccine Cohort
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in one deltoid and a 1-mL intramuscular injection of placebo in the contralateral deltoid on Day 0.
    Arm Title
    Placebo Cohort
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive a 1-mL intramuscular injection of placebo in each deltoid on Day 0.
    Intervention Type
    Biological
    Intervention Name(s)
    V920
    Other Intervention Name(s)
    BPSC-1001
    Intervention Description
    Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Normal saline placebo.
    Primary Outcome Measure Information:
    Title
    Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE)
    Description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event (TEAE) is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). The number of participants that experienced at least one solicited local TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.
    Time Frame
    Up to 14 days postvaccination
    Title
    Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE) by Severity
    Description
    An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A TEAE is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA's Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials": Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least one solicited local TEAE was summarized by grade. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.
    Time Frame
    Up to 14 days postvaccination
    Title
    Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE)
    Description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Systemic reactogenicity signs and symptoms include pyrexia (subjective and objective fever), chills, hyperhidrosis (sweats), myalgia, arthralgia, fatigue, headache, and gastrointestinal symptoms including nausea, vomiting, abdominal pain, and/or diarrhea. The number of participants that experienced at least one solicited systemic TEAE was assessed. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.
    Time Frame
    Up to 14 days postvaccination
    Title
    Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE) by Severity
    Description
    An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A TEAE is defined as an AE that starts or worsens on or after the date and time of the study vaccination. Systemic reactogenicity signs and symptoms include pyrexia (subjective and objective fever), chills, hyperhidrosis (sweats), myalgia, arthralgia, fatigue, headache, and gastrointestinal symptoms including nausea, vomiting, abdominal pain, and/or diarrhea. AEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least 1 solicited systemic TEAE was summarized by grade. Solicited TEAEs occurred from the time of each injection through 14 days following the procedure, facilitated with the use of a memory aid to record participant observations.
    Time Frame
    Up to 14 days postvaccination
    Title
    Number of Participants With One or More Unsolicited Treatment-Emergent Adverse Events (TEAE)
    Description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. The number of participants that experienced at least one unsolicited TEAE was assessed. Unsolicited AEs occurred from the time of injection through 28 days following injection.
    Time Frame
    Up to 28 days postvaccination
    Title
    Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE)
    Description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. A related TEAE is defined as a TEAE that was possibly, probably, or definitely related to the vaccination as assessed by the investigator. The number of participants that experienced at least one unsolicited TEAE related to study vaccination was assessed.
    Time Frame
    Up to 28 days postvaccination
    Title
    Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE) by Severity
    Description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A treatment-emergent adverse event is defined as an AE that starts or worsens on or after the date and time of the study vaccination. A related TEAE is defined as a TEAE that was possibly, probably, or definitely related to the vaccination as assessed by the investigator. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA's Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials": Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The number of participants that experienced at least one unsolicited TEAE related to study vaccination was summarized by grade.
    Time Frame
    Up to 28 days postvaccination
    Title
    Number of Participants With Early Study Discontinuation Due to an Adverse Event
    Description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. The number of participants prematurely withdrawing from the study due to an AE was assessed.
    Time Frame
    Up to 28 days postvaccination
    Title
    Number of Participants With One or More Serious Adverse Event
    Description
    An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The number of participants that experienced one or more SAE was summarized.
    Time Frame
    Up to 180 days postvaccination
    Secondary Outcome Measure Information:
    Title
    Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies
    Description
    The Geometric Mean Titers (GMT) of ZEBOV-specific Immunoglobulin G antibodies were measured by unqualified ZEBOV immunoglobulin (IgG) enzyme-linked immunosorbent assay (ELISA). For titers expressed in ELISA Units/mL, the lower level of quantitation (LLOQ) was 58.84. ZEBOV IgG titers at baseline (Day 0) and analysis Days 7, 14, 28, 56, 84, and 180 were summarized by V920 vaccine dose level and placebo as the mean of log10 titers, transformed into GMT. The geometric standard deviation (GSD) for the GMT at each visit was obtained by exponentiating the standard deviation for the mean of log (base 10) transformed titers.
    Time Frame
    Baseline, Days 7, 14, 28, 56, 84 and 180 post-vaccination
    Title
    Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies
    Description
    The Geometric Mean Titers (GMT) of ZEBOV-specific neutralizing antibodies were measured by pseudovirion neutralization assays (PsVNA). Titers were reported for PsVNA50 values which were derived from the reciprocal of the dilution that resulted in a 50% decrease in luciferase activity. The LLOQ for the PsVNA was 20. If the PsVNA was reported ≤20, the numeric portion of the titer was divided by 2 for statistical purposes, which could result in a reported GMT <20.0. PsVNA50 titers at baseline (Day 0) and analysis Days 7, 14, 28, 56, and 180 were summarized by V920 vaccine dose level and placebo as the mean of log10 titers, transformed into GMT. The geometric standard deviation (GSD) for the GMT at each visit was obtained by exponentiating the standard deviation for the mean of log (base 10) transformed titers.
    Time Frame
    Baseline, Days 7, 14, 28, 56, and 180 post-vaccination
    Title
    Number of Participants With Vaccine Viremia
    Description
    The number of participants with viremia detected by recombinant vesicular stomatitis virus (rVSV) reverse transcription polymerase chain reaction (PCR) of blood specimens was assessed.
    Time Frame
    Days 1, 3, 7, and 14 post-vaccination
    Title
    Number of Participants With Vaccine Shedding/Excretion in Saliva or Urine
    Description
    The number of participants with viremia detected by rVSV reverse transcription PCR of saliva or urine specimens was assessed.
    Time Frame
    Days 1, 3, 7, and 14 post-vaccination
    Title
    Mean Copy Number of Vector RNA (Vector Viremia)
    Description
    Although the protocol specified a secondary endpoint that included the mean copy number of vector RNA (vector viremia), the Polymerase Chain Reaction (PCR) test used for the study reported a qualitative rather than a quantitative outcome, so the proportion of participants with viremia is reported instead of the mean copy number of vector RNA. Qualitative results are therefore reported in Outcome Measures 12 and 13.
    Time Frame
    Up to 14 days postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy adult male or non-pregnant, non-lactating female, ages 18 to 50 (inclusive) at the time of screening Have provided written informed consent before screening Free of clinically significant health problems, as determined by pertinent medical history and clinical examination prior to entry into the study Available, able, and willing to participate for all study visits and procedures Males and females who are willing to practice abstinence from sexual intercourse, or willing to use effective methods of contraception, from at least 30 days prior to vaccination until study end. Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination Score at least 80% on the Comprehension Assessment test Exclusion Criteria: History of prior infection with a filovirus or prior participation in a filovirus vaccine trial History of prior infection with VSV or receipt of a VSV vectored vaccine Is a healthcare worker who has direct contact with patients Has a house-hold contact (HHC) who is immunodeficient, Human Immunodeficiency Virus (HIV)-positive, pregnant, has an unstable medical condition, or is under the age of 5 years Is a childcare worker who has direct contact with children 5 years of age or younger Directly prepares food in the food industry History of employment in an industry involved in contact with ruminant animals, veterinary sciences, or other potential exposure to VSV Planned or frequent contact with animals at-risk of VSV infection (e.g. cattle, horses, pigs, mules, etc.) History of employment or activity which involves potential contact with filoviruses History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions Known allergy to the components of the BPSC1001 vaccine product Receipt of investigational product up to 30 days prior to enrollment or ongoing participation in another clinical trial Receipt of licensed vaccines within 30 days of planned study immunization Ongoing participation in another clinical trial Ability to observe possible local reactions at the eligible injections sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, electrocardiogram, and/or laboratory screening test. This would include a known hemoglobinopathy or coagulation abnormality. Any baseline laboratory screening tests which is outside of acceptable range as defined in the protocol.: alanine aminotransferase, aspartate aminotransferase, creatinine, hemoglobin, platelet count, total white blood cell count, urine protein, urine occult blood, urine glucose Any serologic evidence of hepatitis B or C infection Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, cytotoxic therapy in the previous 5 years, and/or diabetes Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, excluding a single febrile seizure as a child Have an active malignancy or history of metastatic or hematologic malignancy Suspected or known alcohol and/or illicit drug abuse within the past 5 years Moderate or severe illness and/or fever >100.4F within one week prior to vaccination Pregnant or lactating female, or female who intends to become pregnant during the study period Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period History of blood donation within 60 days of enrollment or plans to donate within the study period Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of study entry. (For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day, Intranasal and topical steroids are allowed) Unwilling to allow storage and use of blood for future vaccine research Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study
    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://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    28647166
    Citation
    Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21.
    Results Reference
    derived
    PubMed Identifier
    25830322
    Citation
    Regules JA, Beigel JH, Paolino KM, Voell J, Castellano AR, Hu Z, Munoz P, Moon JE, Ruck RC, Bennett JW, Twomey PS, Gutierrez RL, Remich SA, Hack HR, Wisniewski ML, Josleyn MD, Kwilas SA, Van Deusen N, Mbaya OT, Zhou Y, Stanley DA, Jing W, Smith KS, Shi M, Ledgerwood JE, Graham BS, Sullivan NJ, Jagodzinski LL, Peel SA, Alimonti JB, Hooper JW, Silvera PM, Martin BK, Monath TP, Ramsey WJ, Link CJ, Lane HC, Michael NL, Davey RT Jr, Thomas SJ; rVSVDeltaG-ZEBOV-GP Study Group. A Recombinant Vesicular Stomatitis Virus Ebola Vaccine. N Engl J Med. 2017 Jan 26;376(4):330-341. doi: 10.1056/NEJMoa1414216. Epub 2015 Apr 1.
    Results Reference
    derived

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    Vaccine Treatment for Ebola Virus in Healthy Adults (V920-001)

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