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Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults

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: NCT03478891
Recruitment Status : Completed
First Posted : March 27, 2018
Results First Posted : October 11, 2018
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
The Emmes Company, LLC
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy Adult Immune Responses to Vaccine
Intervention Biological: VRC-EBOMAB092-00-AB (MAb114)
Enrollment 19
Recruitment Details Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland
Pre-assignment Details  
Arm/Group Title Group 1: 5 mg/kg IV Group 2: 25 mg/kg IV Group 3: 50 mg/kg IV
Hide Arm/Group Description

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Period Title: Overall Study
Started 3 5 11
Received MAb114 3 5 10 [1]
Completed 2 5 8
Not Completed 1 0 3
Reason Not Completed
Enrolled, but product never administered             0             0             1
Moved from area             0             0             1
Lost to Follow-up             1             0             1
[1]
A Group 3 subject discontinued prior to MAb114 infusion due to suboptimal IV access
Arm/Group Title Group 1: 5 mg/kg IV Group 2: 25 mg/kg IV Group 3: 50 mg/kg IV Total
Hide Arm/Group Description

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Total of all reporting groups
Overall Number of Baseline Participants 3 5 11 19
Hide Baseline Analysis Population Description
All enrolled subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 5 participants 11 participants 19 participants
39.7  (7.4) 36.4  (9.8) 39.0  (13.9) 38.4  (11.7)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 11 participants 19 participants
21-30 years
0
   0.0%
1
  20.0%
4
  36.4%
5
  26.3%
31-40 years
2
  66.7%
2
  40.0%
2
  18.2%
6
  31.6%
41-50 years
1
  33.3%
2
  40.0%
1
   9.1%
4
  21.1%
51-60 years
0
   0.0%
0
   0.0%
4
  36.4%
4
  21.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 11 participants 19 participants
Female
1
  33.3%
4
  80.0%
7
  63.6%
12
  63.2%
Male
2
  66.7%
1
  20.0%
4
  36.4%
7
  36.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 11 participants 19 participants
Hispanic or Latino
0
   0.0%
1
  20.0%
1
   9.1%
2
  10.5%
Not Hispanic or Latino
3
 100.0%
4
  80.0%
10
  90.9%
17
  89.5%
Unknown or Not Reported
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 3 participants 5 participants 11 participants 19 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   9.1%
1
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
   9.1%
1
   5.3%
White
2
  66.7%
5
 100.0%
7
  63.6%
14
  73.7%
More than one race
1
  33.3%
0
   0.0%
2
  18.2%
3
  15.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 3 participants 5 participants 11 participants 19 participants
3
 100.0%
5
 100.0%
11
 100.0%
19
 100.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 3 participants 5 participants 11 participants 19 participants
88  (8.8) 66.3  (12.6) 73.5  (12.4) 73.9  (13.4)
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 11 participants 19 participants
College or University
2
  66.7%
3
  60.0%
8
  72.7%
13
  68.4%
Advanced Degree
1
  33.3%
2
  40.0%
3
  27.3%
6
  31.6%
1.Primary Outcome
Title Number of Subjects Experiencing Infusion Reaction During Product Administration
Hide Description Possible infusion reaction symptoms: unusually tired/feeling unwell, muscles aches, headache, chills, rigors, nausea, fever, joint pain, urticaria/rash, and pruritus. Also information was collected if administration was slowed down or stopped for reactogenicity reasons.
Time Frame About 30 minutes of product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received MAb114 (N=18), where “N” signifies number of subjects analyzed for this outcome measure.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Overall Number of Participants Analyzed 3 5 10
Measure Type: Count of Participants
Unit of Measure: Participants
Number who experienced infusion reaction
0
   0.0%
0
   0.0%
0
   0.0%
Number who completed infusion in about 30 min
3
 100.0%
5
 100.0%
10
 100.0%
2.Primary Outcome
Title Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Hide Description Subjects recorded 3-day systemic reactogenicity symptoms in a diary after study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, fever and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for “Any Systemic Symptom” is the number of subjects experiencing any systemic symptom as reported at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1.
Time Frame 3 days after product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received MAb114 (N=18), where “N” signifies number of subjects analyzed for this outcome measure.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10) Overall (n=18)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
Overall Number of Participants Analyzed 3 5 10 18
Measure Type: Count of Participants
Unit of Measure: Participants
Malaise None
3
 100.0%
4
  80.0%
8
  80.0%
15
  83.3%
Mild
0
   0.0%
1
  20.0%
2
  20.0%
3
  16.7%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Myalgia None
3
 100.0%
4
  80.0%
9
  90.0%
16
  88.9%
Mild
0
   0.0%
1
  20.0%
1
  10.0%
2
  11.1%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Headache None
3
 100.0%
3
  60.0%
8
  80.0%
14
  77.8%
Mild
0
   0.0%
2
  40.0%
2
  20.0%
4
  22.2%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Chills None
3
 100.0%
4
  80.0%
9
  90.0%
16
  88.9%
Mild
0
   0.0%
1
  20.0%
1
  10.0%
2
  11.1%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nausea None
3
 100.0%
4
  80.0%
9
  90.0%
16
  88.9%
Mild
0
   0.0%
1
  20.0%
1
  10.0%
2
  11.1%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Fever None
3
 100.0%
5
 100.0%
10
 100.0%
18
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Joint Pain None
3
 100.0%
4
  80.0%
9
  90.0%
16
  88.9%
Mild
0
   0.0%
1
  20.0%
1
  10.0%
2
  11.1%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any systemic symptom reported None
3
 100.0%
3
  60.0%
8
  80.0%
14
  77.8%
Mild
0
   0.0%
2
  40.0%
2
  20.0%
4
  22.2%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Hide Description Local reactogenicity symptoms were assessed and recorded by clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that wasn't resolved within 7 days. The number reported for “Any Local Symptom” is the number of subjects reporting any local symptom as reported at the worst severity. Solicited reactogenicity was recorded without attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1.
Time Frame 7 days after product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received MAb114 (N=18), where “N” signifies number of subjects analyzed for this outcome measure.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10) Overall (n=18)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
Overall Number of Participants Analyzed 3 5 10 18
Measure Type: Count of Participants
Unit of Measure: Participants
Pain/Tenderness None
3
 100.0%
5
 100.0%
10
 100.0%
18
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bruising None
3
 100.0%
5
 100.0%
10
 100.0%
18
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Swelling None
3
 100.0%
5
 100.0%
10
 100.0%
18
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Redness None
3
 100.0%
5
 100.0%
10
 100.0%
18
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Pruritis None
3
 100.0%
5
 100.0%
10
 100.0%
18
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any Local Symptoms Reported None
3
 100.0%
5
 100.0%
10
 100.0%
18
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events
Hide Description

Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 28 days after product administration. After the indicated time period through the last expected study visit at 24 weeks after product administration, only new chronic medical conditions collected as unsolicited AEs.

The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity. The relationship between an AE and the product was assessed by the investigator on the basis of his or her clinical judgment and the protocol-specific definitions of Related – There is a reasonable possibility that the AE may be related to the study product and Not Related – There is not a reasonable possibility that the AE is related to the study product.

Time Frame Through 24 weeks after product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received MAb114 (N=18), where “N” signifies number of subjects analyzed for this outcome measure.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10) Overall (n=18)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
Overall Number of Participants Analyzed 3 5 10 18
Measure Type: Count of Participants
Unit of Measure: Participants
Related to MAb114 Administration
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Related to MAb114 Administration
0
   0.0%
2
  40.0%
5
  50.0%
7
  38.9%
5.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Events
Hide Description Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after product administration. Grading done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1. The relationship between a SAE and the product was assessed by the investigator on the basis of his or her clinical judgment and the protocol-specific definitions of Related – There is a reasonable possibility that the SAE may be related to the study product and Not Related – There is not a reasonable possibility that the SAE is related to the study product.
Time Frame Through 24 weeks after product administration
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received MAb114 (N=18), where “N” signifies number of subjects analyzed for this outcome measure.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10) Overall (n=18)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
Overall Number of Participants Analyzed 3 5 10 18
Measure Type: Count of Participants
Unit of Measure: Participants
Related to MAb114 Administration
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Related to MAb114 Administration
0
   0.0%
0
   0.0%
1
  10.0%
1
   5.6%
6.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of MAb114
Hide Description Cmax is the peak serum concentration that MAb114 achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.
Time Frame Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with 28 days of pharmacokinetic data. Additional data may be reported when final data analysis is complete.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Overall Number of Participants Analyzed 3 5 5
Mean (Standard Deviation)
Unit of Measure: µg/mL
198.45  (45.15) 829.38  (237.40) 1961.21  (339.83)
7.Secondary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax) of MAb114
Hide Description Tmax is the time it takes to reach Cmax of MAb114 after it has been administered; it is determined based on the summary PK curve for each study group.
Time Frame Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with 28 days of pharmacokinetic data. Additional data may be reported when final data analysis is complete.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Overall Number of Participants Analyzed 3 5 5
Mean (Standard Deviation)
Unit of Measure: hours
3.21  (1.56) 2.99  (2.16) 2.75  (1.63)
8.Secondary Outcome
Title Mean Serum Concentration of MAb114
Hide Description The mean of individual subject MAb114 serum concentrations by administered dose group
Time Frame Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with 28 days of pharmacokinetic data. Additional data may be reported when final data analysis is complete.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Overall Number of Participants Analyzed 3 5 5
Mean (Standard Deviation)
Unit of Measure: µg/mL
Concentration at Day 7 52.60  (22.10) 373.12  (75.32) 692.64  (201.63)
Concentration at Day 14 42.90  (5.52) 272.91  (46.16) 692.34  (118.19)
Concentration at Day 28 25.46  (5.96) 180.19  (38.82) 427.21  (88.43)
Average Concentration Days 0-28 52.87  (10.87) 306.65  (32.14) 663.87  (129.55)
9.Secondary Outcome
Title Overall IV Half-life (T1/2) of MAb114
Hide Description Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
Time Frame Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-56 days post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with 56 days of pharmacokinetic data. No standard deviation reported for a Group 3 single subject data. Additional data may be reported when final data analysis is complete.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10) Overall (n=18)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
Overall Number of Participants Analyzed 3 5 1 9
Mean (Standard Deviation)
Unit of Measure: days
20.1  (6.9) 26.7  (3.8) 23.6 24.2  (1.8)
10.Secondary Outcome
Title Area Under the Curve (AUC0–28D)
Hide Description The AUC0-28D represents the total drug exposure in 28 days after MAb114 administration; it is determined based on the summary PK curve for each group.
Time Frame Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with 28 days of pharmacokinetic data. Additional data may be reported when final data analysis is complete.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Overall Number of Participants Analyzed 3 5 5
Mean (Standard Deviation)
Unit of Measure: µg x day/mL
1480  (304) 8586  (900) 18588  (3627)
11.Secondary Outcome
Title Volume of Distribution (Vd) at Steady-state
Hide Description Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group.
Time Frame Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with 28 days of pharmacokinetic data. Additional data may be reported when final data analysis is complete.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Overall Number of Participants Analyzed 3 5 5
Mean (Standard Deviation)
Unit of Measure: Liters
5.08  (0.88) 3.93  (0.50) 4.16  (0.74)
12.Secondary Outcome
Title MAb114 Clearance Rate
Hide Description Rate of MAb114 elimination divided by the plasma MAb114 concentration; determined based on the summary PK curve for each study group.
Time Frame Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with 28 days of pharmacokinetic data. Additional data may be reported when final data analysis is complete.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Overall Number of Participants Analyzed 3 5 5
Mean (Standard Deviation)
Unit of Measure: mL/day
199  (45) 108  (21) 115  (15)
13.Secondary Outcome
Title Number of Subjects Who Produced Anti-drug Antibodies to MAb114
Hide Description Serum samples collected 28 days and 56 days after MAb114 administration
Time Frame Days 28 and 56 post-infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with serum samples collected at 28 days and 56 days. Additional data may be reported when final data analysis is complete.
Arm/Group Title Group 1: 5 mg/kg IV (n=3) Group 2: 25 mg/kg IV (n=5) Group 3: 50 mg/kg IV (n=10)
Hide Arm/Group Description:

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Overall Number of Participants Analyzed 3 5 5
Measure Type: Count of Participants
Unit of Measure: Participants
Day 28: Subjects with Anti-drug antibodies Number Analyzed 3 participants 5 participants 5 participants
0
   0.0%
0
   0.0%
0
   0.0%
Day 56: Subjects with Anti-drug antibodies Number Analyzed 3 participants 5 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Solicited adverse events (AEs) included systemic AEs reported by subjects at the worst severity through 3 days post product administration; and local administration site AEs reported at the worst severity through 7 days post product administration. Unsolicited AEs were reported from the date of product administration through 28 days thereafter, and new chronic medical conditions and SAEs with onset any time following the date of product administration through 24 weeks.
Adverse Event Reporting Description Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of subjects reporting the event. The total number of subjects affected in Other AEs includes subjects reporting at least one solicited and/or unsolicited AE. A subject with multiple experiences of the same event is counted once using the event of worst severity. Solicited events are reported separately from unsolicited events.
 
Arm/Group Title Group 1: 5 mg/kg IV Group 2: 25 mg/kg IV Group 3: 50 mg/kg IV
Hide Arm/Group Description

Group 1 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 5 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 2 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 25 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

Group 3 subjects received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0 at a dose of 50 mg/kg.

VRC-EBOMAB092-00-AB (MAb114): VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).

All-Cause Mortality
Group 1: 5 mg/kg IV Group 2: 25 mg/kg IV Group 3: 50 mg/kg IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/5 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: 5 mg/kg IV Group 2: 25 mg/kg IV Group 3: 50 mg/kg IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/5 (0.00%)   1/10 (10.00%) 
Nervous system disorders       
Syncope * 1  0/3 (0.00%)  0/5 (0.00%)  1/10 (10.00%) 
1
Term from vocabulary, MedDRA (22.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: 5 mg/kg IV Group 2: 25 mg/kg IV Group 3: 50 mg/kg IV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   3/5 (60.00%)   5/10 (50.00%) 
Blood and lymphatic system disorders       
Anaemia * 1  0/3 (0.00%)  0/5 (0.00%)  1/10 (10.00%) 
Gastrointestinal disorders       
Dyspepsia * 1  0/3 (0.00%)  1/5 (20.00%)  0/10 (0.00%) 
Abdominal pain * 1  0/3 (0.00%)  0/5 (0.00%)  1/10 (10.00%) 
Nausea  1  0/3 (0.00%)  1/5 (20.00%)  1/10 (10.00%) 
General disorders       
Malaise  1  0/3 (0.00%)  1/5 (20.00%)  2/10 (20.00%) 
Chills  1  0/3 (0.00%)  1/5 (20.00%)  1/10 (10.00%) 
Infections and infestations       
Hordeolum * 1  0/3 (0.00%)  1/5 (20.00%)  0/10 (0.00%) 
Upper respiratory tract infection * 1  0/3 (0.00%)  0/5 (0.00%)  3/10 (30.00%) 
Investigations       
Alanine aminotransferase increased * 1  0/3 (0.00%)  0/5 (0.00%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  0/3 (0.00%)  1/5 (20.00%)  1/10 (10.00%) 
Joint Pain  1  0/3 (0.00%)  1/5 (20.00%)  1/10 (10.00%) 
Nervous system disorders       
Headache  1  0/3 (0.00%)  2/5 (40.00%)  2/10 (20.00%) 
Vascular disorders       
Hypertension * 1  0/3 (0.00%)  0/5 (0.00%)  1/10 (10.00%) 
1
Term from vocabulary, MedDRA (22.0)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
These data represent results being released in response to a public health emergency. Data analysis is ongoing. Final outcome measure data will be updated after the study database is locked and final data analysis completed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Martin Gaudinski, MD
Organization: Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 301-451-8715
EMail: martin.gaudinski@nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT03478891     History of Changes
Other Study ID Numbers: 180069
18-I-0069
First Submitted: March 21, 2018
First Posted: March 27, 2018
Results First Submitted: October 9, 2018
Results First Posted: October 11, 2018
Last Update Posted: July 15, 2019