ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    vrc 608
Previous Study | Return to List | Next Study

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 : Active, not recruiting
First Posted : March 27, 2018
Results First Posted : October 11, 2018
Last Update Posted : October 11, 2018
Sponsor:
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 0 0 0
Not Completed 3 5 11
Reason Not Completed
Enrolled, but product never administered             0             0             1
Still Active in Study             2             5             9
Moved from area             0             0             1
Lost to Follow-up             1             0             0
[1]
Grp 3 subj had suboptimal IV access following enrollment and discontinued prior to MAb114 infusion
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
[Not Specified]
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%
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: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 5 participants 11 participants 19 participants
3 5 11 19
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)
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
Show Outcome Measure DataHide 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: Number
Unit of Measure: participants
Number who experienced infusion reaction 0 0 0
Number who completed infusion in about 30 min 3 5 10
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 symptoms in a diary after study product administration. Solicited symptoms occurring during the 3 days after receipt of study product include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, temperature 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 if they experienced the symptom at any severity during the reporting period. The number reported for any systemic symptom is the number reporting one or more systemic symptom at any severity. Solicited reactogenicity 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 the product administration
Show Outcome Measure DataHide 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
Malaise None
3
 100.0%
4
  80.0%
8
  80.0%
Mild
0
   0.0%
1
  20.0%
2
  20.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
Myalgia None
3
 100.0%
4
  80.0%
9
  90.0%
Mild
0
   0.0%
1
  20.0%
1
  10.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
Headache None
3
 100.0%
3
  60.0%
8
  80.0%
Mild
0
   0.0%
2
  40.0%
2
  20.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
Chills None
3
 100.0%
4
  80.0%
9
  90.0%
Mild
0
   0.0%
1
  20.0%
1
  10.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
Nausea None
3
 100.0%
4
  80.0%
9
  90.0%
Mild
0
   0.0%
1
  20.0%
1
  10.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
Fever None
3
 100.0%
5
 100.0%
10
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
Joint Pain None
3
 100.0%
4
  80.0%
9
  90.0%
Mild
0
   0.0%
1
  20.0%
1
  10.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
Any systemic symptom reported None
3
 100.0%
3
  60.0%
8
  80.0%
Mild
0
   0.0%
2
  40.0%
2
  20.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
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 symptoms assessed and recorded by the 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 if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptoms that were not resolved within 7 days. Solicited reactogenicity recorded without an attribution assessment. If symptoms were reported, 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 the product administration
Show Outcome Measure DataHide 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
Pain/Tenderness None
3
 100.0%
5
 100.0%
10
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
Bruising None
3
 100.0%
5
 100.0%
10
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
Swelling None
3
 100.0%
5
 100.0%
10
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
Redness None
3
 100.0%
5
 100.0%
10
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
Pruritis None
3
 100.0%
5
 100.0%
10
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
Any Local Symptoms Reported None
3
 100.0%
5
 100.0%
10
 100.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
0
   0.0%
0
   0.0%
0
   0.0%
Severe
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Subjects Reporting 1 or More Unsolicited 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.

Between and 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. A subject with multiple experiences of the same event is counted once using the event of highest severity. Grading done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.1.

Time Frame Through 24 weeks after product administration
Outcome Measure Data Not Reported
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.
Time Frame Through 24 weeks after product administration
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Maximum Observed Serum Concentration (Cmax) of MAb114
Hide Description [Not Specified]
Time Frame Through 24 weeks after product administration
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Time to Reach Maximum Observed Serum Concentration (Tmax) of MAb114
Hide Description [Not Specified]
Time Frame Through 24 weeks after product administration
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Mean Serum Concentration of MAb114
Hide Description [Not Specified]
Time Frame Through 24 weeks after product administration
Outcome Measure Data Not Reported
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 Through 24 weeks after product administration
Outcome Measure Data Not Reported
Time Frame Through 24 weeks after product administration
Adverse Event Reporting Description [Not Specified]
 
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%)   0/10 (0.00%) 
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%)   0/5 (0.00%)   0/10 (0.00%) 
These data represent results being released in response to a public health emergency. The study is ongoing and active participants are still being followed. Complete data will be made available at the conclusion of the study.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Martin Gaudinski, MD
Organization: Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 301-451-8715
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: October 11, 2018