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

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: NCT02269423
Recruitment Status : Completed
First Posted : October 21, 2014
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Collaborators:
BioProtection Systems Corporation
United States Department of Defense
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Ebola Virus
Interventions Biological: V920
Other: Placebo
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Period Title: Overall Study
Started 10 10 10 9
Completed 10 9 10 8
Not Completed 0 1 0 1
Reason Not Completed
Discontinued due to change in residence             0             1             0             1
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 9 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 9 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
10
 100.0%
9
 100.0%
39
 100.0%
>=65 years
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 10 participants 10 participants 10 participants 9 participants 39 participants
Female
3
  30.0%
3
  30.0%
2
  20.0%
4
  44.4%
12
  30.8%
Male
7
  70.0%
7
  70.0%
8
  80.0%
5
  55.6%
27
  69.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 9 participants 39 participants
Hispanic or Latino
1
  10.0%
1
  10.0%
1
  10.0%
0
   0.0%
3
   7.7%
Not Hispanic or Latino
9
  90.0%
9
  90.0%
9
  90.0%
9
 100.0%
36
  92.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 9 participants 39 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  20.0%
0
   0.0%
0
   0.0%
1
  11.1%
3
   7.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  30.0%
5
  50.0%
5
  50.0%
3
  33.3%
16
  41.0%
White
4
  40.0%
5
  50.0%
5
  50.0%
5
  55.6%
19
  48.7%
More than one race
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination (V920 dose level or placebo).
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
8
  80.0%
8
  80.0%
10
 100.0%
3
  33.3%
2.Primary Outcome
Title Number of Participants With One or More Solicited Local Treatment-Emergent Adverse Events (TEAE) by Severity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination (V920 dose level or placebo).
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1 (Mild)
6
  60.0%
7
  70.0%
9
  90.0%
3
  33.3%
Grade 2 (Moderate)
2
  20.0%
1
  10.0%
1
  10.0%
0
   0.0%
Grade 3 (Severe)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Grade 4 (Potentially life-threatening)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination (V920 dose level or placebo).
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
9
  90.0%
7
  70.0%
9
  90.0%
6
  66.7%
4.Primary Outcome
Title Number of Participants With One or More Solicited Systemic Treatment-Emergent Adverse Events (TEAE) by Severity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination (V920 dose level or placebo).
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1 (Mild)
3
  30.0%
2
  20.0%
2
  20.0%
5
  55.6%
Grade 2 (Moderate)
3
  30.0%
3
  30.0%
4
  40.0%
1
  11.1%
Grade 3 (Severe)
3
  30.0%
2
  20.0%
3
  30.0%
0
   0.0%
Grade 4 (Potentially life-threatening)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Participants With One or More Unsolicited Treatment-Emergent Adverse Events (TEAE)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination (V920 dose level or placebo).
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
9
  90.0%
9
  90.0%
8
  88.9%
6.Primary Outcome
Title Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination (V920 dose or placebo).
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
8
  80.0%
8
  80.0%
7
  70.0%
6
  66.7%
7.Primary Outcome
Title Number of Participants With One or More Vaccination-Related Unsolicited Treatment-Emergent Adverse Events (TEAE) by Severity
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination (V920 dose level or placebo).
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1 (Mild)
1
  10.0%
2
  20.0%
2
  20.0%
5
  55.6%
Grade 2 (Moderate)
3
  30.0%
3
  30.0%
3
  30.0%
1
  11.1%
Grade 3 (Severe)
4
  40.0%
3
  30.0%
2
  20.0%
0
   0.0%
Grade 4 (Potentially life-threatening)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
8.Primary Outcome
Title Number of Participants With Early Study Discontinuation Due to an Adverse Event
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received study vaccination (V920 dose level or placebo).
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
9.Primary Outcome
Title Number of Participants With One or More Serious Adverse Event
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. 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study vaccination (V920 dose level or placebo).
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Geometric Mean Titers of ZEBOV Envelope Glycoprotein-specific Binding Antibodies
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who were vaccinated and had an evaluable Day 28 immunogenicity result following vaccination and who did not have any protocol deviations that influenced interpretation of immunogenicity endpoints for the specified measurement and timeframe.
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Geometric Mean (Standard Deviation)
Unit of Measure: ELISA Units/mL
Baseline (Day 0) Number Analyzed 10 participants 10 participants 10 participants 9 participants
29.42  (1.00) 29.42  (1.00) 33.85  (1.56) 35.09  (1.70)
Day 7 Number Analyzed 10 participants 10 participants 10 participants 9 participants
29.42  (1.00) 29.42  (1.00) 29.42  (1.00) 34.92  (1.67)
Day 14 Number Analyzed 10 participants 10 participants 9 participants 9 participants
225.23  (2.15) 360.14  (4.04) 621.68  (5.45) 35.24  (1.72)
Day 28 Number Analyzed 10 participants 10 participants 10 participants 9 participants
911.79  (2.09) 1570.84  (2.40) 2662.23  (2.88) 36.54  (1.92)
Day 56 Number Analyzed 10 participants 9 participants 10 participants 9 participants
1425.16  (2.14) 2031.53  (2.02) 2677.04  (3.59) 31.81  (1.26)
Day 84 Number Analyzed 10 participants 9 participants 10 participants 9 participants
1245.40  (1.96) 1816.81  (2.14) 2374.33  (4.36) 31.85  (1.27)
Day 180 Number Analyzed 10 participants 9 participants 10 participants 7 participants
1494.69  (3.21) 1177.40  (2.22) 1658.50  (3.13) 39.44  (2.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort, Placebo Cohort
Comments Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.
Method ANOVA
Comments Adjustments for multiple comparisons were not performed.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2x10^7 Pfu Vaccine Cohort, Placebo Cohort
Comments Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.
Method ANOVA
Comments Adjustments for multiple comparisons were not performed.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1x10^8 Pfu Vaccine Cohort, Placebo Cohort
Comments Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.
Method ANOVA
Comments Adjustments for multiple comparisons were not performed.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort, 2x10^7 Pfu Vaccine Cohort
Comments Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.161
Comments p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.
Method ANOVA
Comments Adjustments for multiple comparisons were not performed.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort, 1x10^8 Pfu Vaccine Cohort
Comments Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.
Method ANOVA
Comments Adjustments for multiple comparisons were not performed.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 2x10^7 Pfu Vaccine Cohort, 1x10^8 Pfu Vaccine Cohort
Comments Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.173
Comments p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.
Method ANOVA
Comments Adjustments for multiple comparisons were not performed.
11.Secondary Outcome
Title Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who were vaccinated and had an evaluable Day 28 immunogenicity result following vaccination and who did not have any protocol deviations that influenced interpretation of immunogenicity endpoints for the specified measurement and timeframe.
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Geometric Mean (Standard Deviation)
Unit of Measure: titer
Baseline Number Analyzed 10 participants 10 participants 10 participants 9 participants
10.0  (1.00) 10.0  (1.00) 10.0  (1.00) 10.0  (1.00)
Day 7 Number Analyzed 10 participants 10 participants 10 participants 9 participants
10.0  (1.00) 10.0  (1.00) 10.0  (1.00) 10.0  (1.00)
Day 14 Number Analyzed 10 participants 10 participants 9 participants 9 participants
46.0  (2.83) 216.5  (3.29) 140.4  (3.58) 10.0  (1.00)
Day 28 Number Analyzed 10 participants 10 participants 10 participants 9 participants
222.8  (3.20) 468.0  (3.96) 447.0  (2.10) 10.0  (1.00)
Day 56 Number Analyzed 10 participants 9 participants 10 participants 9 participants
137.7  (2.38) 170.3  (1.86) 218.6  (3.06) 10.0  (1.00)
Day 180 Number Analyzed 9 participants 9 participants 10 participants 8 participants
29.1  (4.23) 23.0  (2.90) 46.2  (3.06) 10.0  (1.00)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort, Placebo Cohort
Comments Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.
Method ANOVA
Comments Adjustments for multiple comparisons were not performed.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2x10^7 Pfu Vaccine Cohort, Placebo Cohort
Comments Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.
Method ANOVA
Comments Adjustments for multiple comparisons were not performed.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1x10^8 Pfu Vaccine Cohort, Placebo Cohort
Comments Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.
Method ANOVA
Comments Adjustments for multiple comparisons were not performed.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort, 2x10^7 Pfu Vaccine Cohort
Comments Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.
Method ANOVA
Comments Adjustments for multiple comparisons were not performed.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort, 1x10^8 Pfu Vaccine Cohort
Comments Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.124
Comments p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.
Method ANOVA
Comments Adjustments for multiple comparisons were not performed.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection 2x10^7 Pfu Vaccine Cohort, 1x10^8 Pfu Vaccine Cohort
Comments Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.918
Comments p-values are pairwise comparisons of log-transformed titers between each V920 dose, between each V920 dose and placebo, between all V920 dose levels combined and placebo and are from an ANOVA model.
Method ANOVA
Comments Adjustments for multiple comparisons were not performed.
12.Secondary Outcome
Title Number of Participants With Vaccine Viremia
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who were vaccinated and had an evaluable Day 28 immunogenicity result following vaccination and who did not have any protocol deviations that influenced interpretation of immunogenicity endpoints.
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1
10
 100.0%
10
 100.0%
10
 100.0%
0
   0.0%
Day 3
10
 100.0%
10
 100.0%
9
  90.0%
1
  11.1%
Day 7
1
  10.0%
2
  20.0%
3
  30.0%
0.0
Day 14 0.0 0.0 0.0 0.0
13.Secondary Outcome
Title Number of Participants With Vaccine Shedding/Excretion in Saliva or Urine
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects who were vaccinated and had an evaluable Day 28 immunogenicity result following vaccination and who did not have any protocol deviations that influenced interpretation of immunogenicity endpoints.
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 10 10 10 9
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
Day 3
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 7
1
  10.0%
1
  10.0%
0
   0.0%
0
   0.0%
Day 14
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Mean Copy Number of Vector RNA (Vector Viremia)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Although the plan specified in the protocol was to describe vector viremia by summarizing simple mean copy numbers of vector RNA, this data was not collected as the PCR results were qualitative rather than quantitative and were assessed in outcome measures # 12 and #13 instead.
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 180 days
Adverse Event Reporting Description

All participants that received study vaccination (V920 dose or placebo) and had safety follow-up data.

The AEs in this section are combined (solicited and unsolicited) events. The results reported under the Outcome Measures are based on specific conditions (separated for solicited and unsolicited AEs and days postvaccination). For example, the terms "pyrexia" and "hyperhidrosis" in this section correspond to "objective fever, "subjective fever", and "sweats" as reported in the Outcome Measures.

 
Arm/Group Title 3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Hide Arm/Group 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.
All-Cause Mortality
3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/9 (0.00%)    
Hide Serious Adverse Events
3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/9 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
3x10^6 Plaque-forming Units (Pfu) Vaccine Cohort 2x10^7 Pfu Vaccine Cohort 1x10^8 Pfu Vaccine Cohort Placebo Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      10/10 (100.00%)      10/10 (100.00%)      9/9 (100.00%)    
Blood and lymphatic system disorders         
Anemia  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0
Lymphopenia  1  7/10 (70.00%)  7 0/10 (0.00%)  0 2/10 (20.00%)  2 0/9 (0.00%)  0
Neutropenia  1  3/10 (30.00%)  3 0/10 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0
Eye disorders         
Blepharospasm  1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1
Photophobia  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain  1  2/10 (20.00%)  2 2/10 (20.00%)  2 2/10 (20.00%)  3 1/9 (11.11%)  2
Diarrhea  1  1/10 (10.00%)  1 0/10 (0.00%)  0 2/10 (20.00%)  2 1/9 (11.11%)  1
Nausea  1  2/10 (20.00%)  2 3/10 (30.00%)  4 2/10 (20.00%)  3 1/9 (11.11%)  1
Vomiting  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0
General disorders         
Chills  1  3/10 (30.00%)  3 4/10 (40.00%)  4 7/10 (70.00%)  7 1/9 (11.11%)  1
Fatigue  1  6/10 (60.00%)  9 4/10 (40.00%)  5 7/10 (70.00%)  12 4/9 (44.44%)  4
Injection site bruising  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1
Injection site pain  1  8/10 (80.00%)  8 8/10 (80.00%)  11 10/10 (100.00%)  15 4/9 (44.44%)  5
Injection site swelling  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0
Pyrexia  1  4/10 (40.00%)  7 4/10 (40.00%)  6 8/10 (80.00%)  13 1/9 (11.11%)  1
Infections and infestations         
Pharyngitis  1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1
Pharyngitis streptococcal  1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1
Sinusitis  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0
Upper respiratory tract infection  1  1/10 (10.00%)  1 2/10 (20.00%)  2 0/10 (0.00%)  0 1/9 (11.11%)  1
Investigations         
Alanine aminotransferase increased  1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 2/9 (22.22%)  2
Aspartate aminotransferase increased  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 2/9 (22.22%)  2
Blood urea increased  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0
Hemoglobin decreased  1  0/10 (0.00%)  0 0/10 (0.00%)  0 3/10 (30.00%)  3 2/9 (22.22%)  2
Lymphocyte count decreased  1  0/10 (0.00%)  0 7/10 (70.00%)  7 5/10 (50.00%)  5 0/9 (0.00%)  0
Platelet count decreased  1  1/10 (10.00%)  1 2/10 (20.00%)  2 0/10 (0.00%)  0 0/9 (0.00%)  0
Prothrombin time prolonged  1  1/10 (10.00%)  1 1/10 (10.00%)  1 1/10 (10.00%)  1 3/9 (33.33%)  3
White blood cell count decreased  1  2/10 (20.00%)  2 2/10 (20.00%)  2 3/10 (30.00%)  3 1/9 (11.11%)  1
White blood cell count increased  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0
Neutrophil count decreased  1  1/10 (10.00%)  1 2/10 (20.00%)  2 3/10 (30.00%)  3 0/9 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/10 (10.00%)  1 1/10 (10.00%)  1 5/10 (50.00%)  6 2/9 (22.22%)  2
Myalgia  1  6/10 (60.00%)  6 4/10 (40.00%)  4 6/10 (60.00%)  6 1/9 (11.11%)  1
Rhabdomyolysis  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0
Nervous system disorders         
Dizziness postural  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0
Headache  1  6/10 (60.00%)  11 6/10 (60.00%)  8 8/10 (80.00%)  14 7/9 (77.78%)  10
Sinus headache  1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1
Psychiatric disorders         
Phobia  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0
Renal and urinary disorders         
Hematuria  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0
Proteinuria  1  0/10 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  2 1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0
Nasal congestion  1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1
Nasal dryness  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0
Rhinorrhea  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatitis contact  1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1
Hyperhidrosis  1  0/10 (0.00%)  0 1/10 (10.00%)  1 4/10 (40.00%)  4 1/9 (11.11%)  1
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 or military 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 WRAIR, USAMRIID, and the sponsor's policies and then forward the publication for review to the sponsor and usarmy.detrick.medcom-usamrmc.list.clearances@mail.mil 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: NCT02269423    
Other Study ID Numbers: V920-001
NLG0307 (WRAIR #2163) ( Other Identifier: NewLink Genetics Corp. )
V920-001 ( Other Identifier: Merck Protocol Number )
First Submitted: October 10, 2014
First Posted: October 21, 2014
Results First Submitted: September 13, 2019
Results First Posted: October 23, 2019
Last Update Posted: October 23, 2019