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Placebo Controlled, Dose Response, Safety and Immunogenicity Study of Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-004)

Primary Purpose

Ebola Virus

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
V920 Vaccine
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 - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy adult male or non-pregnant, non-lactating adult female, ages 18 to 60 (inclusive) at the time of screening
  2. Have provided written informed consent prior to screening procedures
  3. Free of clinically significant health problems, as determined by pertinent medical history, physical examination and clinical judgment of the investigator.
  4. Available, able, and willing to participate for all study visits and procedures.
  5. Males and females who are willing to practice abstinence from sexual intercourse with the opposite sex, or willing to use effective methods of contraception, from at least 30 days prior to vaccination until study end.
  6. Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination by:

    1. Using effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse
    2. Avoiding the sharing of needles, razors, or toothbrushes
    3. Avoiding open-mouth kissing
  7. Resides in the geographic area of a clinical study site for 1 year after vaccination without risk of deployment outside the U.S.

Exclusion Criteria:

  1. History of prior infection with a filovirus or prior participation in a filovirus vaccine trial
  2. History of prior infection with VSV or receipt of a VSV vectored vaccine
  3. Has been involved in the care in any capacity of a patient with Ebola virus infection within the previous 21 days
  4. Is a healthcare worker who has direct contact with patients (nurse, physician, dentist, emergency medical technician, dental hygienist)
  5. Has a house-hold contact (HHC) who is immunodeficient, on immunosuppressive medications, human immunodeficiency virus (HIV)-positive, pregnant, has an unstable medical condition
  6. Has an HHC, or is a childcare worker who has direct contact with children, 5 years of age or younger
  7. Direct hands-on job preparing food in the food industry
  8. History of employment in an industry involved in contact with ruminant animals, veterinary sciences, or other potential exposure to VSV
  9. History of employment or activity which involves potential contact with filoviruses
  10. History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
  11. Known allergy to the components of the BPSC1001 vaccine product
  12. Receipt of investigational product up to 30 days prior to randomization or ongoing participation in another clinical trial
  13. Receipt of licensed non-live vaccines within 14 days of planned study immunization (30 days for live vaccines)
  14. 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
  15. 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 examination, and/or laboratory screening test. This would include a known hemoglobinopathy or coagulation abnormality.
  16. Any baseline laboratory screening test which in the opinion of the investigator, is considered clinically significant
  17. Any serologic evidence of hepatitis B or C infection
  18. Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV-1, HIV-2 infection, cytotoxic therapy in the previous 5 years, and/or diabetes
  19. Any chronic or active neurologic disorder, including migraines, seizures, and epilepsy, excluding a single febrile seizure as a child
  20. Have a known history of Guillain-Barré Syndrome
  21. Have an active malignancy or history of metastatic or hematologic malignancy
  22. Suspected or known alcohol and/or illicit drug abuse within the past 5 years
  23. Moderate or severe illness and/or fever >100.4°F within 1 week prior to vaccination (can be rescheduled)
  24. Pregnant or lactating female, or female who intends to become pregnant during the study period
  25. Administration of IgGs and/or any blood products within the 120 days preceding study entry or planned administration during the study period
  26. History of blood donation within 60 days of enrollment or plans to donate within the study period
  27. Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of study entry

    1. For corticosteroids, this includes prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day
    2. Intranasal, topical, and intra-articular steroids are allowed
  28. Unwilling to allow storage and use of blood for future vaccine research

28. Research staff or the immediate family of research staff directly involved with the clinical study.

29. Unwilling to undergo diagnostic evaluation of joint signs and symptoms, which may include arthrocentesis if clinically indicated based on presence of effusion and if the procedure is acceptable to the subject at the time (Cohort 2 only) 30. Unwilling to undergo diagnostic evaluation of skin rash, to include punch biopsy if clinically indicated and if the procedure is acceptable to the subject at the time (Cohort 2 only) 31. Research staff or the immediate family of research staff directly involved in the clinical study 32. 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 33. Elective surgery or hospitalization planned during the period of study participation 34. Has traveled to an area where the World Health Organization has declared as an Ebola outbreak zone 35. History of chronic inflammatory disease (e.g., rheumatoid arthritis, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, Crohn's disease, ulcerative colitis, and gout), symptomatic osteoarthritis, or any other autoimmune or autoinflammatory disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Experimental

    Placebo Comparator

    Arm Label

    3x10^3 pfu Vaccine Cohort 1

    3x10^4 pfu Vaccine Cohort 1

    3x10^5 pfu Vaccine Cohort 1

    3x10^6 pfu Vaccine Cohort 1

    9x10^6 pfu Vaccine Cohort 2

    2x10^7 pfu Vaccine Cohort 2

    1x10^8 pfu Vaccine Cohort 2

    Placebo Cohort 1

    3x10^6 pfu Vaccine Cohort 2

    Placebo Cohort 2

    Arm Description

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

    Participants will receive a 1-mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.

    Participants will receive a 1-mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.

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

    Participants will receive a 1-mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.

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

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With One or More Solicited Injection-site Adverse Events by Severity
    An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, tenderness and swelling. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA 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 percentage of participants that experienced at least 1 solicited injection-site AE was summarized by grade.
    Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity
    An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Systemic AEs included subjective and objective fever, shivering/chills, sweats, myalgia, arthralgia, joint swelling, joint tenderness, fatigue, headache, gastrointestinal symptoms (nausea, vomiting, abdominal pain, and diarrhea), mucosal lesion, and skin lesion (including any blisters). 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 percentage of participants that experienced at least one systemic AE was summarized by grade.
    Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity
    An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Unsolicited vaccine-related AEs were those events not specifically listed as either an injection-site (local) or systemic in the VRC and were reported as at least possibly related to the study vaccine or placebo. The AEs were further assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least one unsolicited vaccine-related AE was summarized by grade..
    Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity
    An adverse event is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An 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. SAEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening; 5=Fatal. The percentage of participants that experienced at least 1 SAE was summarized by grade.
    Geometric Mean Titers (GMTs) of Zaire Ebola Virus- (ZEBOV)-Specific Immunoglobulin-G (IgG) Antibody
    Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA).
    Optimum Dose for General Use Prophylaxis With V920
    The optimum dose for general use prophylaxis with V920 was determined following the review of all immunogenicity and safety data.

    Secondary Outcome Measures

    Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ)
    Participants had blood, assessed for evidence of V920 via polymerase chain reaction (PCR). Mean copies of RNA was reported for all participants who had reading ≥ the LLOQ (62.5 copies/mL)
    Percentage of Participants With Seroconversion for ZEBOV-specific IgG
    Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 ELISA Units/mL that was also at least a 4-fold increase in titer compared to baseline.
    Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies
    Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined plaque reduction neutralization titer (reciprocal of the dilution that resulted in a 60% decrease in plaques) (PRNT60).

    Full Information

    First Posted
    December 8, 2014
    Last Updated
    January 21, 2020
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    BioProtection Systems Corporation, Department of Health and Human Services
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02314923
    Brief Title
    Placebo Controlled, Dose Response, Safety and Immunogenicity Study of Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-004)
    Official Title
    A Phase 1 Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Response 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
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 5, 2014 (Actual)
    Primary Completion Date
    June 23, 2016 (Actual)
    Study Completion Date
    June 23, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    BioProtection Systems Corporation, Department of Health and Human Services

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it. This is a study of the anti-Ebola vaccine BPSC-1001 to see if it is safe and to see how it affects people's immune system.
    Detailed Description
    Between 1994 and the present, there have been many Ebola viruses (EBOV) outbreaks affecting mostly central Africa. However, the 2014 West African outbreak significantly exceeds all previous outbreaks in geographic range, number of individuals affected and in disruption of typical activities of civil society. This is a Phase 1 safety and tolerability study to evaluate a novel vaccine to Ebola using a live replicating vesicular stomatitis virus (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).

    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
    Model Description
    The study comprised two separate cohorts. Cohort 1 consisted of the 4 lower V920 dose groups (3x10^3 pfu, 3x10^4 pfu, 3x10^5 pfu, and 3x10^6 pfu). Cohort 2 consisted of the 3 higher V920 dose groups (9x10^6 pfu, 2x10^7 pfu, 1x10^8 pfu) plus a bridging group that received vaccine at the highest dose evaluated in Cohort 1 (i.e. 3x10^6 pfu). Both Cohorts 1 and 2 had a placebo group.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    513 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    3x10^3 pfu Vaccine Cohort 1
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1-mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
    Arm Title
    3x10^4 pfu Vaccine Cohort 1
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1-mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
    Arm Title
    3x10^5 pfu Vaccine Cohort 1
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1-mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
    Arm Title
    3x10^6 pfu Vaccine Cohort 1
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
    Arm Title
    9x10^6 pfu Vaccine Cohort 2
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1-mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
    Arm Title
    2x10^7 pfu Vaccine Cohort 2
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
    Arm Title
    1x10^8 pfu Vaccine Cohort 2
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
    Arm Title
    Placebo Cohort 1
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0.
    Arm Title
    3x10^6 pfu Vaccine Cohort 2
    Arm Type
    Experimental
    Arm Description
    Participants will receive a 1-mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
    Arm Title
    Placebo Cohort 2
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0.
    Intervention Type
    Biological
    Intervention Name(s)
    V920 Vaccine
    Other Intervention Name(s)
    BPSC-1001
    Intervention Description
    Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^3, 3x10^4, 3x10^5, 3x10^6, 9x10^6, 2x10^7, or 1x10^8 pfu.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    0.9% Saline
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With One or More Solicited Injection-site Adverse Events by Severity
    Description
    An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, tenderness and swelling. AEs were assessed for severity by the investigator according to a toxicity grading scale based on the FDA 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 percentage of participants that experienced at least 1 solicited injection-site AE was summarized by grade.
    Time Frame
    Up to 14 days postvaccination
    Title
    Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity
    Description
    An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Systemic AEs included subjective and objective fever, shivering/chills, sweats, myalgia, arthralgia, joint swelling, joint tenderness, fatigue, headache, gastrointestinal symptoms (nausea, vomiting, abdominal pain, and diarrhea), mucosal lesion, and skin lesion (including any blisters). 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 percentage of participants that experienced at least one systemic AE was summarized by grade.
    Time Frame
    Up to 14 days postvaccination
    Title
    Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity
    Description
    An AE can be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Unsolicited vaccine-related AEs were those events not specifically listed as either an injection-site (local) or systemic in the VRC and were reported as at least possibly related to the study vaccine or placebo. The AEs were further assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening. The percentage of participants that experienced at least one unsolicited vaccine-related AE was summarized by grade..
    Time Frame
    Up to 56 days postvaccination
    Title
    Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity
    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. An 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. SAEs were assessed for severity by the investigator as follows: Grade 1=Mild; Grade 2=Moderate; Grade 3=Severe; Grade 4=Potentially life-threatening; 5=Fatal. The percentage of participants that experienced at least 1 SAE was summarized by grade.
    Time Frame
    Up to 360 days postvaccination
    Title
    Geometric Mean Titers (GMTs) of Zaire Ebola Virus- (ZEBOV)-Specific Immunoglobulin-G (IgG) Antibody
    Description
    Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA).
    Time Frame
    28 days postvaccination
    Title
    Optimum Dose for General Use Prophylaxis With V920
    Description
    The optimum dose for general use prophylaxis with V920 was determined following the review of all immunogenicity and safety data.
    Time Frame
    Day 360
    Secondary Outcome Measure Information:
    Title
    Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ)
    Description
    Participants had blood, assessed for evidence of V920 via polymerase chain reaction (PCR). Mean copies of RNA was reported for all participants who had reading ≥ the LLOQ (62.5 copies/mL)
    Time Frame
    Days 1, 2, 3, 4, 7, 14 and 28 post-vaccination
    Title
    Percentage of Participants With Seroconversion for ZEBOV-specific IgG
    Description
    Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 ELISA Units/mL that was also at least a 4-fold increase in titer compared to baseline.
    Time Frame
    7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination
    Title
    Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies
    Description
    Blood was drawn on Days 7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined plaque reduction neutralization titer (reciprocal of the dilution that resulted in a 60% decrease in plaques) (PRNT60).
    Time Frame
    7, 14, 28, 56, 84 (Cohort 1 only), 180, and 360 days postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy adult male or non-pregnant, non-lactating adult female, ages 18 to 60 (inclusive) at the time of screening Have provided written informed consent prior to screening procedures Free of clinically significant health problems, as determined by pertinent medical history, physical examination and clinical judgment of the investigator. Available, able, and willing to participate for all study visits and procedures. Males and females who are willing to practice abstinence from sexual intercourse with the opposite sex, 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 by: Using effective barrier prophylaxis, such as latex condoms, during penetrative sexual intercourse Avoiding the sharing of needles, razors, or toothbrushes Avoiding open-mouth kissing Resides in the geographic area of a clinical study site for 1 year after vaccination without risk of deployment outside the U.S. 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 Has been involved in the care in any capacity of a patient with Ebola virus infection within the previous 21 days Is a healthcare worker who has direct contact with patients (nurse, physician, dentist, emergency medical technician, dental hygienist) Has a house-hold contact (HHC) who is immunodeficient, on immunosuppressive medications, human immunodeficiency virus (HIV)-positive, pregnant, has an unstable medical condition Has an HHC, or is a childcare worker who has direct contact with children, 5 years of age or younger Direct hands-on job preparing 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 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 randomization or ongoing participation in another clinical trial Receipt of licensed non-live vaccines within 14 days of planned study immunization (30 days for live vaccines) 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 examination, and/or laboratory screening test. This would include a known hemoglobinopathy or coagulation abnormality. Any baseline laboratory screening test which in the opinion of the investigator, is considered clinically significant Any serologic evidence of hepatitis B or C infection Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV-1, HIV-2 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 a known history of Guillain-Barré Syndrome 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 >100.4°F within 1 week prior to vaccination (can be rescheduled) Pregnant or lactating female, or female who intends to become pregnant during the study period Administration of IgGs 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 includes prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day Intranasal, topical, and intra-articular steroids are allowed Unwilling to allow storage and use of blood for future vaccine research 28. Research staff or the immediate family of research staff directly involved with the clinical study. 29. Unwilling to undergo diagnostic evaluation of joint signs and symptoms, which may include arthrocentesis if clinically indicated based on presence of effusion and if the procedure is acceptable to the subject at the time (Cohort 2 only) 30. Unwilling to undergo diagnostic evaluation of skin rash, to include punch biopsy if clinically indicated and if the procedure is acceptable to the subject at the time (Cohort 2 only) 31. Research staff or the immediate family of research staff directly involved in the clinical study 32. 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 33. Elective surgery or hospitalization planned during the period of study participation 34. Has traveled to an area where the World Health Organization has declared as an Ebola outbreak zone 35. History of chronic inflammatory disease (e.g., rheumatoid arthritis, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, Crohn's disease, ulcerative colitis, and gout), symptomatic osteoarthritis, or any other autoimmune or autoinflammatory 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

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    28606591
    Citation
    Heppner DG Jr, Kemp TL, Martin BK, Ramsey WJ, Nichols R, Dasen EJ, Link CJ, Das R, Xu ZJ, Sheldon EA, Nowak TA, Monath TP; V920-004 study team. Safety and immunogenicity of the rVSV∆G-ZEBOV-GP Ebola virus vaccine candidate in healthy adults: a phase 1b randomised, multicentre, double-blind, placebo-controlled, dose-response study. Lancet Infect Dis. 2017 Aug;17(8):854-866. doi: 10.1016/S1473-3099(17)30313-4. Epub 2017 Jun 9.
    Results Reference
    result
    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

    Learn more about this trial

    Placebo Controlled, Dose Response, Safety and Immunogenicity Study of Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-004)

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