Trial Outcomes & Findings for Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults (NCT NCT03478891)
NCT ID: NCT03478891
Last Updated: 2020-10-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
7 days after product administration
Results posted on
2020-10-26
Participant Flow
Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland
Participant milestones
| Measure |
Group 1: 5 mg/kg IV
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: 25 mg/kg IV
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: 50 mg/kg IV
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 Study
STARTED
|
3
|
5
|
11
|
|
Overall Study
Received MAb114
|
3
|
5
|
10
|
|
Overall Study
COMPLETED
|
2
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
Reasons for withdrawal
| Measure |
Group 1: 5 mg/kg IV
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: 25 mg/kg IV
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: 50 mg/kg IV
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 Study
Enrolled, but product never administered
|
0
|
0
|
1
|
|
Overall Study
Moved from area
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
Baseline Characteristics
Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults
Baseline characteristics by cohort
| Measure |
Group 1: 5 mg/kg IV
n=3 Participants
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: 25 mg/kg IV
n=5 Participants
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: 50 mg/kg IV
n=11 Participants
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
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.7 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
36.4 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
39.0 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
38.4 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
|
Age, Customized
21-30 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Age, Customized
31-40 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Age, Customized
41-50 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Customized
51-60 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Weight
|
88 kg
STANDARD_DEVIATION 8.8 • n=5 Participants
|
66.3 kg
STANDARD_DEVIATION 12.6 • n=7 Participants
|
73.5 kg
STANDARD_DEVIATION 12.4 • n=5 Participants
|
73.9 kg
STANDARD_DEVIATION 13.4 • n=4 Participants
|
|
Education
College or University
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Education
Advanced Degree
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: About 30 minutes of product administrationPopulation: Subjects who received MAb114 (N=18), where "N" signifies number of subjects analyzed for this outcome measure.
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.
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=10 Participants
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 (n=18)
Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
|
|---|---|---|---|---|
|
Number of Subjects Experiencing Infusion Reaction During Product Administration
Number who completed infusion in about 30 min
|
3 Participants
|
5 Participants
|
10 Participants
|
—
|
|
Number of Subjects Experiencing Infusion Reaction During Product Administration
Number who experienced infusion reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 3 days after product administrationPopulation: Subjects who received MAb114 (N=18), where "N" signifies number of subjects analyzed for this outcome measure.
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.
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=10 Participants
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 (n=18)
n=18 Participants
Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
|
|---|---|---|---|---|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Malaise · None
|
3 Participants
|
4 Participants
|
8 Participants
|
15 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Malaise · Mild
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Malaise · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Malaise · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Myalgia · None
|
3 Participants
|
4 Participants
|
9 Participants
|
16 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Myalgia · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Myalgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Headache · None
|
3 Participants
|
3 Participants
|
8 Participants
|
14 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Headache · Mild
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Headache · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Chills · None
|
3 Participants
|
4 Participants
|
9 Participants
|
16 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Chills · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Nausea · None
|
3 Participants
|
4 Participants
|
9 Participants
|
16 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Nausea · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Fever · None
|
3 Participants
|
5 Participants
|
10 Participants
|
18 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Fever · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Fever · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Fever · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Joint Pain · None
|
3 Participants
|
4 Participants
|
9 Participants
|
16 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Joint Pain · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Joint Pain · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Joint Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Any systemic symptom reported · None
|
3 Participants
|
3 Participants
|
8 Participants
|
14 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Any systemic symptom reported · Mild
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Any systemic symptom reported · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Product Administration
Any systemic symptom reported · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days after product administrationPopulation: Subjects who received MAb114 (N=18), where "N" signifies number of subjects analyzed for this outcome measure.
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.
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=10 Participants
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 (n=18)
n=18 Participants
Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
|
|---|---|---|---|---|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · None
|
3 Participants
|
5 Participants
|
10 Participants
|
18 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Bruising · None
|
3 Participants
|
5 Participants
|
10 Participants
|
18 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Bruising · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Bruising · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Bruising · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · None
|
3 Participants
|
5 Participants
|
10 Participants
|
18 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · None
|
3 Participants
|
5 Participants
|
10 Participants
|
18 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritis · None
|
3 Participants
|
5 Participants
|
10 Participants
|
18 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritis · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritis · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritis · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptoms Reported · None
|
3 Participants
|
5 Participants
|
10 Participants
|
18 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptoms Reported · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptoms Reported · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptoms Reported · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through 24 weeks after product administrationPopulation: Subjects who received MAb114 (N=18), where "N" signifies number of subjects analyzed for this outcome measure.
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.
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=10 Participants
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 (n=18)
n=18 Participants
Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
|
|---|---|---|---|---|
|
Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events
Related to MAb114 Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events
Not Related to MAb114 Administration
|
0 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Through 24 weeks after product administrationPopulation: Subjects who received MAb114 (N=18), where "N" signifies number of subjects analyzed for this outcome measure.
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.
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=10 Participants
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 (n=18)
n=18 Participants
Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
|
|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events
Related to MAb114 Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Serious Adverse Events
Not Related to MAb114 Administration
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusionPopulation: Subjects with 28 days of pharmacokinetic data.
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.
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=5 Participants
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 (n=18)
Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
|
|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) of MAb114
|
198.45 µg/mL
Standard Deviation 45.15
|
829.38 µg/mL
Standard Deviation 237.40
|
1961.21 µg/mL
Standard Deviation 339.83
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusionPopulation: Subjects with 28 days of pharmacokinetic data.
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.
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=5 Participants
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 (n=18)
Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Serum Concentration (Tmax) of MAb114
|
3.21 hours
Standard Deviation 1.56
|
2.99 hours
Standard Deviation 2.16
|
2.75 hours
Standard Deviation 1.63
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusionPopulation: Subjects with 28 days of pharmacokinetic data.
The mean of individual subject MAb114 serum concentrations by administered dose group
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=5 Participants
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 (n=18)
Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
|
|---|---|---|---|---|
|
Mean Serum Concentration of MAb114
Concentration at Day 7
|
52.60 µg/mL
Standard Deviation 22.19
|
373.12 µg/mL
Standard Deviation 75.32
|
692.64 µg/mL
Standard Deviation 201.63
|
—
|
|
Mean Serum Concentration of MAb114
Concentration at Day 14
|
42.90 µg/mL
Standard Deviation 5.53
|
272.91 µg/mL
Standard Deviation 46.16
|
629.34 µg/mL
Standard Deviation 118.19
|
—
|
|
Mean Serum Concentration of MAb114
Concentration at Day 28
|
25.46 µg/mL
Standard Deviation 5.96
|
180.19 µg/mL
Standard Deviation 38.82
|
427.21 µg/mL
Standard Deviation 88.43
|
—
|
|
Mean Serum Concentration of MAb114
Average Concentration Days 0-28
|
52.87 µg/mL
Standard Deviation 10.87
|
306.65 µg/mL
Standard Deviation 32.14
|
663.87 µg/mL
Standard Deviation 129.55
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-56 days post-infusionPopulation: Subjects with 56 days of pharmacokinetic data. No standard deviation reported for a Group 3 single subject data.
Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum.
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=1 Participants
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 (n=18)
n=9 Participants
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 IV Half-life (T1/2) of MAb114
|
20.1 days
Standard Deviation 6.9
|
26.7 days
Standard Deviation 3.8
|
23.6 days
|
24.2 days
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusionPopulation: Subjects with 28 days of pharmacokinetic data.
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.
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=5 Participants
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 (n=18)
Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
|
|---|---|---|---|---|
|
Area Under the Curve (AUC0-28D)
|
1480 µg x day/mL
Standard Deviation 304
|
8586 µg x day/mL
Standard Deviation 900
|
18588 µg x day/mL
Standard Deviation 3627
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusionPopulation: Subjects with 28 days of pharmacokinetic data.
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.
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=5 Participants
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 (n=18)
Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
|
|---|---|---|---|---|
|
Volume of Distribution (Vd) at Steady-state
|
5.08 Liters
Standard Deviation 0.88
|
3.93 Liters
Standard Deviation 0.50
|
4.16 Liters
Standard Deviation 0.74
|
—
|
SECONDARY outcome
Timeframe: Pre-infusion (baseline), end of infusion (0h), 1 hr, 3 hr, 6 hr, 24 hr, 48 hr and 7-28 days post-infusionPopulation: Subjects with 28 days of pharmacokinetic data.
Rate of MAb114 elimination divided by the plasma MAb114 concentration; determined based on the summary PK curve for each study group.
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=5 Participants
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 (n=18)
Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
|
|---|---|---|---|---|
|
MAb114 Clearance Rate
|
199 mL/day
Standard Deviation 45
|
108 mL/day
Standard Deviation 21
|
115 mL/day
Standard Deviation 15
|
—
|
SECONDARY outcome
Timeframe: Days 28 and 56 post-infusionPopulation: Subjects with serum samples collected at 28 days and 56 days.
Serum samples collected 28 days and 56 days after MAb114 administration
Outcome measures
| Measure |
Group 1: 5 mg/kg IV (n=3)
n=3 Participants
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: 25 mg/kg IV (n=5)
n=5 Participants
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: 50 mg/kg IV (n=10)
n=5 Participants
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 (n=18)
Total number of subjects who received a single IV infusion of a Human Monoclonal Antibody (MAb), VRC-EBOMAB092-00-AB (MAb114), on Day 0
|
|---|---|---|---|---|
|
Number of Subjects Who Produced Anti-drug Antibodies to MAb114
Day 28: Subjects with Anti-drug antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects Who Produced Anti-drug Antibodies to MAb114
Day 56: Subjects with Anti-drug antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Group 1: 5 mg/kg IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: 25 mg/kg IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 3: 50 mg/kg IV
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: 5 mg/kg IV
n=3 participants at risk
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: 25 mg/kg IV
n=5 participants at risk
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: 50 mg/kg IV
n=10 participants at risk
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).
|
|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • 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.
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.
|
0.00%
0/5 • 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.
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.
|
10.0%
1/10 • 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.
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.
|
Other adverse events
| Measure |
Group 1: 5 mg/kg IV
n=3 participants at risk
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: 25 mg/kg IV
n=5 participants at risk
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: 50 mg/kg IV
n=10 participants at risk
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).
|
|---|---|---|---|
|
Infections and infestations
Hordeolum
|
0.00%
0/3 • 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.
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.
|
20.0%
1/5 • 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.
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.
|
0.00%
0/10 • 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.
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • 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.
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.
|
20.0%
1/5 • 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.
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.
|
0.00%
0/10 • 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.
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • 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.
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.
|
0.00%
0/5 • 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.
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.
|
10.0%
1/10 • 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.
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.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • 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.
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.
|
0.00%
0/5 • 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.
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.
|
10.0%
1/10 • 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.
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.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • 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.
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.
|
0.00%
0/5 • 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.
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.
|
10.0%
1/10 • 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.
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.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • 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.
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.
|
0.00%
0/5 • 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.
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.
|
10.0%
1/10 • 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.
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • 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.
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.
|
0.00%
0/5 • 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.
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.
|
30.0%
3/10 • 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.
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.
|
|
General disorders
Malaise
|
0.00%
0/3 • 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.
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.
|
20.0%
1/5 • 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.
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.
|
20.0%
2/10 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • 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.
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.
|
20.0%
1/5 • 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.
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.
|
10.0%
1/10 • 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.
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 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.
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.
|
40.0%
2/5 • 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.
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.
|
20.0%
2/10 • 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.
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.
|
|
General disorders
Chills
|
0.00%
0/3 • 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.
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.
|
20.0%
1/5 • 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.
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.
|
10.0%
1/10 • 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.
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 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.
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.
|
20.0%
1/5 • 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.
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.
|
10.0%
1/10 • 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.
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.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
0.00%
0/3 • 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.
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.
|
20.0%
1/5 • 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.
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.
|
10.0%
1/10 • 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.
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.
|
Additional Information
Martin Gaudinski, MD
Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health
Phone: 301-451-8715
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place