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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02314923
Recruitment Status : Completed
First Posted : December 11, 2014
Results First Posted : January 2, 2020
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
BioProtection Systems Corporation
Department of Health and Human Services
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Ebola Virus
Interventions Biological: V920 Vaccine
Other: Placebo
Enrollment 513
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 3x10^3 Plaque-forming Units (Pfu) V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Hide Arm/Group Description Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0. Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0 Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Period Title: Overall Study
Started 64 64 64 64 74 20 48 47 48 20
Treated 64 64 64 64 74 20 47 [1] 47 48 20
Completed 61 60 62 63 73 19 43 42 46 20
Not Completed 3 4 2 1 1 1 5 5 2 0
Reason Not Completed
Death             0             0             0             1             0             0             0             0             0             0
Lost to Follow-up             2             3             1             0             0             0             3             4             2             0
Withdrawal by Subject             0             0             1             0             1             0             1             0             0             0
Physician Decision             0             1             0             0             0             0             0             0             0             0
Participant unavailable             0             0             0             0             0             1             0             0             0             0
Screen failure             0             0             0             0             0             0             1             0             0             0
Participant relocation             1             0             0             0             0             0             0             1             0             0
[1]
One participant did not receive vaccination due to missing blood sample at randomization.
Arm/Group Title 3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2 Total
Hide Arm/Group Description Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0 Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0. Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0. Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0 Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0. Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0. Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0 Total of all reporting groups
Overall Number of Baseline Participants 64 64 64 64 74 20 47 47 48 20 512
Hide Baseline Analysis Population Description
Baseline characteristics were reported for treated participants. 1 participant in 9x10^6 pfu V920: Cohort 2 arm did not receive vaccine
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 64 participants 64 participants 74 participants 20 participants 47 participants 47 participants 48 participants 20 participants 512 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
64
 100.0%
64
 100.0%
64
 100.0%
64
 100.0%
74
 100.0%
20
 100.0%
47
 100.0%
47
 100.0%
48
 100.0%
20
 100.0%
512
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 64 participants 64 participants 64 participants 74 participants 20 participants 47 participants 47 participants 48 participants 20 participants 512 participants
Female
32
  50.0%
33
  51.6%
31
  48.4%
33
  51.6%
39
  52.7%
8
  40.0%
24
  51.1%
22
  46.8%
15
  31.3%
8
  40.0%
245
  47.9%
Male
32
  50.0%
31
  48.4%
33
  51.6%
31
  48.4%
35
  47.3%
12
  60.0%
23
  48.9%
25
  53.2%
33
  68.8%
12
  60.0%
267
  52.1%
1.Primary Outcome
Title Percentage of Participants With One or More Solicited Injection-site Adverse Events by Severity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination and had data available for the endpoint.
Arm/Group Title 3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Overall Number of Participants Analyzed 64 64 64 64 74 20 47 47 48 20
Measure Type: Number
Unit of Measure: Percentage of Participants
Grade 1 (Mild) 17.2 21.9 29.7 45.3 10.8 30.0 61.7 63.8 47.9 5.0
Grade 2 (Moderate) 0 1.6 1.6 1.6 1.4 0 8.5 8.5 16.7 0
Grade 3 (Severe) 0 0 0 0 0 0 0 0 0 0
Grade 4 (Potentially life-threatening) 0 0 0 0 0 0 0 0 0 0
2.Primary Outcome
Title Percentage of Participants With One or More Solicited Systemic Adverse Events by Severity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination and had data available for the endpoint.
Arm/Group Title 3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Overall Number of Participants Analyzed 64 64 64 64 74 20 47 47 48 20
Measure Type: Number
Unit of Measure: Percentage of Participants
Grade 1 (Mild) 29.7 39.1 45.3 53.1 41.9 25.0 46.8 46.8 43.8 20.0
Grade 2 (Moderate) 10.9 4.7 10.9 14.1 4.1 25.0 19.1 23.4 27.1 5.0
Grade 3 (Severe) 0 0 3.1 1.6 0 0 2.1 4.3 4.2 0
Grade 4 (Potentially life-threatening) 0 0 0 0 0 0 0 0 0 0
3.Primary Outcome
Title Percentage of Participants With One or More Unsolicited Vaccine-related Adverse Event by Severity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination and had data available for the endpoint.
Arm/Group Title 3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Overall Number of Participants Analyzed 64 64 64 64 74 20 47 47 48 20
Measure Type: Number
Unit of Measure: Percentage of Participants
1 (Mild) 7.8 14.1 7.8 9.4 6.8 15.0 14.9 17.0 14.6 10.0
2 (Moderate) 4.7 3.1 0 3.1 0 0 6.4 2.1 2.1 0
3 (Severe) 0 0 0 1.6 0 0 0 0 0 5.0
4 (Potentially Life-threatening) 0 0 0 0 0 0 0 0 0 0
4.Primary Outcome
Title Percentage of Participants With One or More Serious Adverse Event (SAE) by Severity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination and had data available for the endpoint.
Arm/Group Title 3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Overall Number of Participants Analyzed 64 64 64 64 74 20 47 47 48 20
Measure Type: Number
Unit of Measure: Percentage of Participants
1 (Mild) 0 0 0 1.6 0 0 0 0 0 0
2 (Moderate) 0 0 0 0 0 0 0 0 0 0
3 (Severe) 0 0 0 0 1.4 0 0 0 0 0
4 (Potentially Life-threatening) 0 0 1.6 0 0 0 0 0 0 0
5 (Fatal) 0 0 0 1.6 0 0 0 0 0 0
5.Primary Outcome
Title Geometric Mean Titers (GMTs) of Zaire Ebola Virus- (ZEBOV)-Specific Immunoglobulin-G (IgG) Antibody
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.
Arm/Group Title 3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Overall Number of Participants Analyzed 64 61 64 63 25 20 45 46 45 20
Geometric Mean (Standard Deviation)
Unit of Measure: ELISA Units/mL
777.8  (5.06) 767.8  (3.96) 909.6  (3.26) 1139.9  (3.25) 30.3  (1.00) 1518.9  (3.20) 977.4  (3.01) 1542.8  (3.10) 1930.3  (2.22) 35.9  (2.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3x10^3 Pfu V920: Cohort 1, 3x10^4 Pfu V920: Cohort 1
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.951
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 3x10^3 Pfu V920: Cohort 1, 3x10^5 Pfu V920: Cohort 1
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.458
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 3x10^3 Pfu V920: Cohort 1, 3x10^6 Pfu V920: Cohort 1
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 3x10^3 Pfu V920: Cohort 1, Placebo: Cohort 1
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 3x10^3 Pfu V920: Cohort 1, 3x10^6 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 3x10^3 Pfu V920: Cohort 1, 9x10^6 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.325
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection 3x10^3 Pfu V920: Cohort 1, 2x10^7 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection 3x10^3 Pfu V920: Cohort 1, 1x10^8 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection 3x10^4 Pfu V920: Cohort 1, 3x10^5 Pfu V920: Cohort 1
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.427
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection 3x10^4 Pfu V920: Cohort 1, 3x10^6 Pfu V920: Cohort 1
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection 3x10^4 Pfu V920: Cohort 1, Placebo: Cohort 1
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection 3x10^4 Pfu V920: Cohort 1, 3x10^6 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection 3x10^4 Pfu V920: Cohort 1, 9x10^6 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.303
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection 3x10^4 Pfu V920: Cohort 1, 2x10^7 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection 3x10^4 Pfu V920: Cohort 1, 1x10^8 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection 3x10^5 Pfu V920: Cohort 1, 3x10^6 Pfu V920: Cohort 1
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.286
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection 3x10^5 Pfu V920: Cohort 1, Placebo: Cohort 1
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection 3x10^5 Pfu V920: Cohort 1, 3x10^6 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.094
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection 3x10^5 Pfu V920: Cohort 1, 9x10^6 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.757
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection 3x10^5 Pfu V920: Cohort 1, 2x10^7 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection 3x10^5 Pfu V920: Cohort 1, 1x10^8 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection 3x10^6 Pfu V920: Cohort 1, Placebo: Cohort 1
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection 3x10^6 Pfu V920: Cohort 1, 3x10^6 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.348
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection 3x10^6 Pfu V920: Cohort 1, 9x10^6 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.508
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection 3x10^6 Pfu V920: Cohort 1, 2x10^7 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.191
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection 3x10^6 Pfu V920: Cohort 1, 1x10^8 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection 3x10^6 Pfu V920: Cohort 2, 9x10^6 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.169
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection 3x10^6 Pfu V920: Cohort 2, 2x10^7 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.961
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection 3x10^6 Pfu V920: Cohort 2, 1x10^8 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.454
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection 3x10^6 Pfu V920: Cohort 2, Placebo: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection 9x10^6 Pfu V920: Cohort 2, 2x10^7 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection 9x10^6 Pfu V920: Cohort 2, 1x10^8 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection 9x10^6 Pfu V920: Cohort 2, Placebo: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection 2x10^7 Pfu V920: Cohort 2, 1x10^8 Pfu V920: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.370
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection 1x10^8 Pfu V920: Cohort 2, Placebo: Cohort 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Primary Outcome
Title Optimum Dose for General Use Prophylaxis With V920
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study vaccine
Arm/Group Title All Vaccinated Participants
Hide Arm/Group Description:
All participants that received study vaccine.
Overall Number of Participants Analyzed 512
Measure Type: Number
Unit of Measure: pfu
20000000
7.Secondary Outcome
Title Mean Copies of Vector Ribonucleic Acid (RNA) for Participants With a V920 Polymerase Chain Reaction (PCR) Result ≥ Lower Limit of Quantification (LLOQ)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.
Arm/Group Title 3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Overall Number of Participants Analyzed 64 61 64 63 25 20 45 46 45 20
Geometric Mean (Standard Deviation)
Unit of Measure: copies/mL
Day 1 Number Analyzed 0 participants 0 participants 0 participants 5 participants 0 participants 1 participants 10 participants 9 participants 27 participants 0 participants
118.04  (1.185) 109.40 [1]   (NA) 144.72  (1.511) 184.65  (1.893) 304.45  (2.534)
Day 2 Number Analyzed 1 participants 0 participants 0 participants 20 participants 0 participants 1 participants 9 participants 9 participants 13 participants 0 participants
4107.00 [1]   (NA) 127.13  (1.511) 109.40 [1]   (NA) 158.74  (1.901) 172.24  (1.628) 161.67  (1.644)
Day 3 Number Analyzed 1 participants 1 participants 0 participants 3 participants 0 participants 0 participants 0 participants 1 participants 3 participants 0 participants
12649.00 [1]   (NA) 109.40 [1]   (NA) 703.36  (25.106) 109.40 [1]   (NA) 740.96  (8.199)
Day 4 Number Analyzed 1 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
23936.00 [1]   (NA) 109.40 [1]   (NA)
Day 7 Number Analyzed 1 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
787.00 [1]   (NA) 160.00 [1]   (NA)
Day 14 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
109.40 [1]   (NA)
Day 28 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
[1]
SD could not be calculated due to low n
8.Secondary Outcome
Title Percentage of Participants With Seroconversion for ZEBOV-specific IgG
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.
Arm/Group Title 3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Overall Number of Participants Analyzed 64 61 64 63 25 20 45 46 45 20
Measure Type: Number
Unit of Measure: Percentage of Participants
Day 7 Number Analyzed 61 participants 60 participants 64 participants 62 participants 1 participants 20 participants 44 participants 45 participants 45 participants 14 participants
0 1.7 0 0 0 0 0 2.2 2.2 0
Day 14 Number Analyzed 61 participants 59 participants 63 participants 62 participants 1 participants 20 participants 44 participants 44 participants 44 participants 14 participants
11.5 20.3 20.6 50.0 0 40.0 54.5 81.8 72.7 0
Day 28 Number Analyzed 64 participants 61 participants 64 participants 63 participants 25 participants 20 participants 45 participants 46 participants 45 participants 20 participants
82.8 80.3 89.1 93.7 0 90.0 91.1 93.5 95.6 5.0
Day 56 Number Analyzed 63 participants 61 participants 64 participants 63 participants 25 participants 20 participants 44 participants 46 participants 45 participants 20 participants
85.7 86.9 92.2 93.7 0 90.0 93.2 97.8 97.8 0
Day 84 Number Analyzed 60 participants 61 participants 63 participants 61 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants
81.7 85.2 87.3 93.4 0
Day 180 Number Analyzed 61 participants 58 participants 61 participants 61 participants 0 participants 18 participants 41 participants 41 participants 41 participants 1 participants
82.0 75.9 83.6 89.9 94.4 90.2 97.6 97.6 0
Day 360 Number Analyzed 51 participants 52 participants 56 participants 57 participants 2 participants 18 participants 38 participants 39 participants 41 participants 0 participants
78.4 75.0 80.4 89.5 0 94.4 89.5 97.4 93.2
Any time postvaccination Number Analyzed 64 participants 61 participants 64 participants 63 participants 25 participants 20 participants 45 participants 46 participants 45 participants 20 participants
89.1 90.2 93.8 96.8 0 100.0 97.8 97.8 97.8 5.0
9.Secondary Outcome
Title Percentage of Participants With Seroconversion for ZEBOV Neutralizing Antibodies
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who were vaccinated, had endpoint titer results on Days 0 (baseline) and 28 (relative Days 24-35), and who did not have any protocol violations that influenced interpretation of immunogenicity endpoints. A subset of 25 placebo recipients in Cohort 1 were prospectively identified for testing of immunogenicity endpoints.
Arm/Group Title 3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Hide Arm/Group Description:
Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0
Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0.
Participants received a 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0.
Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
Overall Number of Participants Analyzed 64 61 64 63 25 20 45 46 45 20
Measure Type: Number
Unit of Measure: Percentage of Participants
Day 7 Number Analyzed 63 participants 60 participants 64 participants 63 participants 25 participants 20 participants 45 participants 46 participants 45 participants 20 participants
0 0 1.6 1.6 0 0 2.2 2.2 2.2 0
Day 14 Number Analyzed 63 participants 59 participants 63 participants 63 participants 25 participants 20 participants 45 participants 45 participants 44 participants 20 participants
9.5 13.6 42.9 52.4 0 45.0 55.6 71.1 81.8 0
Day 28 Number Analyzed 63 participants 61 participants 64 participants 63 participants 25 participants 20 participants 45 participants 46 participants 45 participants 20 participants
76.2 70.5 87.5 93.7 0 85.0 91.1 95.7 100.0 5.0
Day 56 Number Analyzed 63 participants 61 participants 64 participants 63 participants 25 participants 20 participants 44 participants 46 participants 45 participants 20 participants
79.4 70.5 89.1 93.7 0 90.0 93.2 95.7 97.8 0
Day 84 (Cohort 1 only) Number Analyzed 62 participants 61 participants 63 participants 62 participants 25 participants 0 participants 0 participants 0 participants 0 participants 0 participants
75.8 72.1 88.9 90.3 4.0
Day 180 Number Analyzed 63 participants 58 participants 61 participants 62 participants 24 participants 18 participants 42 participants 42 participants 41 participants 20 participants
81.0 81.0 88.5 91.9 0 94.4 95.2 95.2 100.0 5.0
Day 360 Number Analyzed 53 participants 52 participants 56 participants 57 participants 22 participants 18 participants 38 participants 39 participants 44 participants 19 participants
77.4 78.8 82.1 93.0 0 94.4 84.6 97.5 100.0 5.3
Any time postvaccination Number Analyzed 64 participants 61 participants 64 participants 63 participants 25 participants 20 participants 45 participants 46 participants 45 participants 20 participants
89.1 88.5 96.9 98.4 4.0 100.0 97.8 100.0 100.0 10.0
Time Frame Up to 360 days
Adverse Event Reporting Description All participants that received study vaccination (V920 dose or placebo).
 
Arm/Group Title 3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Hide Arm/Group Description Participants received a single 1.0 mL intramuscular injection of V920 3x10^3 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of V920 3x10^4 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of V920 3x10^5 pfu in the deltoid on Day 0. Participants received a 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0 Participants received a 1.0 mL intramuscular injection of V920 9x10^6 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0. Participants received a single 1.0 mL intramuscular injection of placebo in the deltoid on Day 0
All-Cause Mortality
3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)      0/64 (0.00%)      0/64 (0.00%)      1/64 (1.56%)      0/74 (0.00%)      0/20 (0.00%)      0/47 (0.00%)      0/47 (0.00%)      0/48 (0.00%)      0/20 (0.00%)    
Hide Serious Adverse Events
3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/64 (0.00%)      0/64 (0.00%)      1/64 (1.56%)      2/64 (3.13%)      1/74 (1.35%)      0/20 (0.00%)      0/47 (0.00%)      0/47 (0.00%)      0/48 (0.00%)      0/20 (0.00%)    
General disorders                     
Chest pain  1  0/64 (0.00%)  0 0/64 (0.00%)  0 1/64 (1.56%)  1 0/64 (0.00%)  0 0/74 (0.00%)  0 0/20 (0.00%)  0 0/47 (0.00%)  0 0/47 (0.00%)  0 0/48 (0.00%)  0 0/20 (0.00%)  0
Injury, poisoning and procedural complications                     
Head injury  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 1/64 (1.56%)  1 0/74 (0.00%)  0 0/20 (0.00%)  0 0/47 (0.00%)  0 0/47 (0.00%)  0 0/48 (0.00%)  0 0/20 (0.00%)  0
Ulna fracture  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 1/74 (1.35%)  1 0/20 (0.00%)  0 0/47 (0.00%)  0 0/47 (0.00%)  0 0/48 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders                     
Presyncope  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 1/64 (1.56%)  1 0/74 (0.00%)  0 0/20 (0.00%)  0 0/47 (0.00%)  0 0/47 (0.00%)  0 0/48 (0.00%)  0 0/20 (0.00%)  0
Vascular disorders                     
Peripheral ischaemia  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 1/74 (1.35%)  1 0/20 (0.00%)  0 0/47 (0.00%)  0 0/47 (0.00%)  0 0/48 (0.00%)  0 0/20 (0.00%)  0
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
3x10^3 Pfu V920: Cohort 1 3x10^4 Pfu V920: Cohort 1 3x10^5 Pfu V920: Cohort 1 3x10^6 Pfu V920: Cohort 1 Placebo: Cohort 1 3x10^6 Pfu V920: Cohort 2 9x10^6 Pfu V920: Cohort 2 2x10^7 Pfu V920: Cohort 2 1x10^8 Pfu V920: Cohort 2 Placebo: Cohort 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/64 (46.88%)      38/64 (59.38%)      44/64 (68.75%)      52/64 (81.25%)      43/74 (58.11%)      14/20 (70.00%)      43/47 (91.49%)      41/47 (87.23%)      41/48 (85.42%)      9/20 (45.00%)    
Gastrointestinal disorders                     
Abdominal pain  1  7/64 (10.94%)  9 3/64 (4.69%)  3 6/64 (9.38%)  7 2/64 (3.13%)  2 4/74 (5.41%)  5 0/20 (0.00%)  0 4/47 (8.51%)  4 3/47 (6.38%)  3 5/48 (10.42%)  5 1/20 (5.00%)  1
Diarrhoea  1  6/64 (9.38%)  13 2/64 (3.13%)  3 6/64 (9.38%)  7 6/64 (9.38%)  7 8/74 (10.81%)  9 2/20 (10.00%)  2 7/47 (14.89%)  8 6/47 (12.77%)  7 11/48 (22.92%)  13 1/20 (5.00%)  1
Nausea  1  9/64 (14.06%)  9 6/64 (9.38%)  7 13/64 (20.31%)  14 11/64 (17.19%)  13 12/74 (16.22%)  14 4/20 (20.00%)  4 4/47 (8.51%)  4 5/47 (10.64%)  7 6/48 (12.50%)  6 3/20 (15.00%)  3
Vomiting  1  3/64 (4.69%)  5 2/64 (3.13%)  2 4/64 (6.25%)  4 5/64 (7.81%)  5 4/74 (5.41%)  5 1/20 (5.00%)  1 1/47 (2.13%)  1 1/47 (2.13%)  1 3/48 (6.25%)  4 0/20 (0.00%)  0
General disorders                     
Chills  1  6/64 (9.38%)  6 3/64 (4.69%)  3 7/64 (10.94%)  8 21/64 (32.81%)  22 6/74 (8.11%)  6 3/20 (15.00%)  3 16/47 (34.04%)  18 13/47 (27.66%)  14 15/48 (31.25%)  17 1/20 (5.00%)  1
Fatigue  1  12/64 (18.75%)  13 13/64 (20.31%)  16 14/64 (21.88%)  17 21/64 (32.81%)  24 14/74 (18.92%)  16 6/20 (30.00%)  6 17/47 (36.17%)  22 18/47 (38.30%)  25 22/48 (45.83%)  25 4/20 (20.00%)  6
Pyrexia  1  3/64 (4.69%)  3 4/64 (6.25%)  6 6/64 (9.38%)  6 16/64 (25.00%)  19 3/74 (4.05%)  3 6/20 (30.00%)  8 14/47 (29.79%)  18 18/47 (38.30%)  24 15/48 (31.25%)  20 0/20 (0.00%)  0
Swelling  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 0/74 (0.00%)  0 0/20 (0.00%)  0 2/47 (4.26%)  2 3/47 (6.38%)  3 1/48 (2.08%)  1 0/20 (0.00%)  0
Tenderness  1  10/64 (15.63%)  10 12/64 (18.75%)  14 16/64 (25.00%)  17 26/64 (40.63%)  27 7/74 (9.46%)  7 4/20 (20.00%)  4 28/47 (59.57%)  29 28/47 (59.57%)  28 24/48 (50.00%)  24 1/20 (5.00%)  1
Infections and infestations                     
Bronchitis  1  1/64 (1.56%)  1 0/64 (0.00%)  0 1/64 (1.56%)  1 1/64 (1.56%)  1 2/74 (2.70%)  2 2/20 (10.00%)  2 0/47 (0.00%)  0 0/47 (0.00%)  0 0/48 (0.00%)  0 0/20 (0.00%)  0
Upper respiratory tract infection  1  0/64 (0.00%)  0 1/64 (1.56%)  2 1/64 (1.56%)  1 2/64 (3.13%)  2 6/74 (8.11%)  6 0/20 (0.00%)  0 0/47 (0.00%)  0 1/47 (2.13%)  1 0/48 (0.00%)  0 0/20 (0.00%)  0
Investigations                     
Alanine aminotransferase increased  1  0/64 (0.00%)  0 2/64 (3.13%)  2 0/64 (0.00%)  0 1/64 (1.56%)  1 0/74 (0.00%)  0 0/20 (0.00%)  0 2/47 (4.26%)  2 2/47 (4.26%)  2 2/48 (4.17%)  2 3/20 (15.00%)  3
Haemoglobin decreased  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 0/74 (0.00%)  0 0/20 (0.00%)  0 2/47 (4.26%)  2 2/47 (4.26%)  2 1/48 (2.08%)  1 2/20 (10.00%)  4
Musculoskeletal and connective tissue disorders                     
Arthralgia  1  9/64 (14.06%)  18 11/64 (17.19%)  23 15/64 (23.44%)  23 11/64 (17.19%)  24 9/74 (12.16%)  13 4/20 (20.00%)  6 10/47 (21.28%)  22 11/47 (23.40%)  30 7/48 (14.58%)  21 2/20 (10.00%)  10
Joint swelling  1  3/64 (4.69%)  5 2/64 (3.13%)  4 2/64 (3.13%)  2 3/64 (4.69%)  5 0/74 (0.00%)  0 1/20 (5.00%)  1 3/47 (6.38%)  3 4/47 (8.51%)  7 0/48 (0.00%)  0 1/20 (5.00%)  3
Myalgia  1  12/64 (18.75%)  15 13/64 (20.31%)  16 15/64 (23.44%)  16 14/64 (21.88%)  15 10/74 (13.51%)  11 8/20 (40.00%)  12 19/47 (40.43%)  22 16/47 (34.04%)  18 16/48 (33.33%)  18 1/20 (5.00%)  2
Pain in extremity  1  5/64 (7.81%)  5 7/64 (10.94%)  7 12/64 (18.75%)  12 20/64 (31.25%)  20 6/74 (8.11%)  6 4/20 (20.00%)  4 28/47 (59.57%)  30 27/47 (57.45%)  28 25/48 (52.08%)  25 1/20 (5.00%)  1
Nervous system disorders                     
Dizziness  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 4/64 (6.25%)  5 0/74 (0.00%)  0 1/20 (5.00%)  1 0/47 (0.00%)  0 0/47 (0.00%)  0 1/48 (2.08%)  1 0/20 (0.00%)  0
Headache  1  15/64 (23.44%)  24 19/64 (29.69%)  23 20/64 (31.25%)  27 32/64 (50.00%)  41 23/74 (31.08%)  33 7/20 (35.00%)  12 23/47 (48.94%)  32 22/47 (46.81%)  30 21/48 (43.75%)  28 3/20 (15.00%)  11
Skin and subcutaneous tissue disorders                     
Erythema  1  0/64 (0.00%)  0 1/64 (1.56%)  1 0/64 (0.00%)  0 1/64 (1.56%)  1 0/74 (0.00%)  0 0/20 (0.00%)  0 1/47 (2.13%)  1 5/47 (10.64%)  5 1/48 (2.08%)  1 0/20 (0.00%)  0
Hyperhidrosis  1  6/64 (9.38%)  7 3/64 (4.69%)  3 5/64 (7.81%)  5 5/64 (7.81%)  5 3/74 (4.05%)  5 4/20 (20.00%)  4 6/47 (12.77%)  7 11/47 (23.40%)  12 13/48 (27.08%)  15 0/20 (0.00%)  0
Skin lesion  1  0/64 (0.00%)  0 0/64 (0.00%)  0 0/64 (0.00%)  0 1/64 (1.56%)  1 0/74 (0.00%)  0 0/20 (0.00%)  0 2/47 (4.26%)  2 2/47 (4.26%)  3 3/48 (6.25%)  5 0/20 (0.00%)  0
Vascular disorders                     
Hypertension  1  3/64 (4.69%)  3 1/64 (1.56%)  1 2/64 (3.13%)  2 0/64 (0.00%)  0 3/74 (4.05%)  3 1/20 (5.00%)  1 3/47 (6.38%)  3 0/47 (0.00%)  0 0/48 (0.00%)  0 0/20 (0.00%)  0
1
Term from vocabulary, MedDRA 17.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All data may be published in the open medical literature with the identity of the subjects protected. Anyone desiring to publish or present data obtained during the conduct of the study will conform to the Sponsor’s policies and then forward the publication for review to the Sponsor prior to submission.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02314923    
Other Study ID Numbers: V920-004
NLG0507 ( Other Identifier: NewLink Genetics Corp. )
V920-004 ( Other Identifier: Merck Protocol Number )
First Submitted: December 8, 2014
First Posted: December 11, 2014
Results First Submitted: December 6, 2019
Results First Posted: January 2, 2020
Last Update Posted: February 5, 2020