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Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00845650
Recruitment Status : Completed
First Posted : February 18, 2009
Results First Posted : June 13, 2018
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Emergent BioSolutions

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Anthrax
Interventions Biological: AIGIV 3.5 mg/kg
Biological: Gamunex 90 mg/kg
Biological: AIGIV 7.0 mg/kg
Biological: Gamunex 180 mg/kg
Biological: AIGIV 14.0 mg/kg
Biological: Gamunex 360 mg/kg
Enrollment 129
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AIGIV 3.5 mg/kg (Cohort A) Gamunex 90 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) Gamunex 180 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C) Gamunex 360 mg/kg (Cohort C)
Hide Arm/Group Description AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. Gamunex 90 mg/kg total IgG as a single intravenous infusion. AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. Gamunex 180 mg/kg total IgG as a single intravenous infusion. AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. Gamunex 360 mg/kg total IgG as a single intravenous infusion.
Period Title: Overall Study
Started 31 [1] 5 31 14 31 [2] 17 [1]
Completed 30 5 28 13 28 15
Not Completed 1 0 3 1 3 2
Reason Not Completed
Withdrawal by Subject             0             0             0             0             2             0
Lost to Follow-up             0             0             3             1             0             1
Sponsor hold on dosing             0             0             0             0             1             1
Unable to access IV line             1             0             0             0             0             0
[1]
1 subject not dosed
[2]
2 subjects not dosed
Arm/Group Title AIGIV 3.5 mg/kg (Cohort A) Gamunex 90 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) Gamunex 180 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C) Gamunex 360 mg/kg (Cohort C) Total
Hide Arm/Group Description AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. Gamunex 90 mg/kg total IgG as a single intravenous infusion. AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. Gamunex 180 mg/kg total IgG as a single intravenous infusion. AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. Gamunex 360 mg/kg total IgG as a single intravenous infusion. Total of all reporting groups
Overall Number of Baseline Participants 31 5 31 14 31 17 129
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 5 participants 31 participants 14 participants 31 participants 17 participants 129 participants
35.1  (10.3) 35.2  (13.8) 32.1  (10.6) 37.1  (9.4) 33.3  (9.1) 36.6  (9.8) 34.3  (10.0)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 5 participants 31 participants 14 participants 31 participants 17 participants 129 participants
18 to < 30 years
12
  38.7%
2
  40.0%
16
  51.6%
3
  21.4%
13
  41.9%
4
  23.5%
50
  38.8%
30 to < 40 years
7
  22.6%
1
  20.0%
7
  22.6%
6
  42.9%
7
  22.6%
8
  47.1%
36
  27.9%
40 to < 50 years
9
  29.0%
1
  20.0%
6
  19.4%
3
  21.4%
11
  35.5%
3
  17.6%
33
  25.6%
≥ 50 years
3
   9.7%
1
  20.0%
2
   6.5%
2
  14.3%
0
   0.0%
2
  11.8%
10
   7.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 5 participants 31 participants 14 participants 31 participants 17 participants 129 participants
Female
10
  32.3%
2
  40.0%
13
  41.9%
5
  35.7%
17
  54.8%
10
  58.8%
57
  44.2%
Male
21
  67.7%
3
  60.0%
18
  58.1%
9
  64.3%
14
  45.2%
7
  41.2%
72
  55.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 5 participants 31 participants 14 participants 31 participants 17 participants 129 participants
Hispanic or Latino
1
   3.2%
0
   0.0%
0
   0.0%
2
  14.3%
3
   9.7%
2
  11.8%
8
   6.2%
Not Hispanic or Latino
30
  96.8%
5
 100.0%
31
 100.0%
12
  85.7%
28
  90.3%
15
  88.2%
121
  93.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 5 participants 31 participants 14 participants 31 participants 17 participants 129 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
1
   3.2%
0
   0.0%
2
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
26
  83.9%
2
  40.0%
16
  51.6%
7
  50.0%
16
  51.6%
9
  52.9%
76
  58.9%
White
5
  16.1%
3
  60.0%
14
  45.2%
5
  35.7%
12
  38.7%
6
  35.3%
45
  34.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.2%
0
   0.0%
1
   0.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
2
  14.3%
1
   3.2%
2
  11.8%
5
   3.9%
Body Mass Index  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 5 participants 31 participants 14 participants 31 participants 17 participants 129 participants
< 25 kg/m^2
10
  32.3%
1
  20.0%
11
  35.5%
3
  21.4%
9
  29.0%
7
  41.2%
41
  31.8%
≥ 25 kg/m^2
21
  67.7%
4
  80.0%
20
  64.5%
11
  78.6%
22
  71.0%
10
  58.8%
88
  68.2%
1.Primary Outcome
Title Number of Participants Reporting Adverse Events (AEs)
Hide Description Any untoward medical occurrence reported to or observed by the principal investigator (PI), including as identified from other safety assessments (eg, vital signs, clinical laboratory testing, electrocardiogram).
Time Frame From the time of infusion through Day 90.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all subjects who received any infusion of AIGIV or Gamunex.
Arm/Group Title AIGIV 3.5 mg/kg (Cohort A) Gamunex 90 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) Gamunex 180 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C) Gamunex 360 mg/kg (Cohort C)
Hide Arm/Group Description:
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 90 mg/kg total IgG as a single intravenous infusion.
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 180 mg/kg total IgG as a single intravenous infusion.
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Gamunex 360 mg/kg total IgG as a single intravenous infusion.
Overall Number of Participants Analyzed 30 5 31 14 29 16
Measure Type: Count of Participants
Unit of Measure: Participants
28
  93.3%
5
 100.0%
29
  93.5%
11
  78.6%
29
 100.0%
15
  93.8%
2.Secondary Outcome
Title Maximum Plasma Titer/Concentration of TNA (Toxin Neutralizing Antibody) (Cmax)
Hide Description Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion. Assay results are reported as the 50% neutralization factor, TNA NF50: the ED50 of the test sample (ie, effective dilution of test sample that neutralized 50% of toxin) divided by the ED50 of the reference standard.
Time Frame From the time of infusion through Day 90 postinfusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) intent-to-treat (ITT) population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Arm/Group Title AIGIV 3.5 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C)
Hide Arm/Group Description:
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Overall Number of Participants Analyzed 27 28 28
Mean (Standard Deviation)
Unit of Measure: NF50 (50% neutralization factor)
1.07  (0.26) 2.21  (0.48) 4.31  (0.98)
3.Secondary Outcome
Title Time of Cmax
Hide Description Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Time Frame From the time of infusion through Day 90 postinfusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Arm/Group Title AIGIV 3.5 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C)
Hide Arm/Group Description:
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Overall Number of Participants Analyzed 27 28 28
Mean (Standard Deviation)
Unit of Measure: hours
4.49  (13.65) 7.81  (23.06) 7.35  (22.53)
4.Secondary Outcome
Title Area Under the Curve to the Last Time With a Measurable TNA Titer (AUC[0-t])
Hide Description Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Time Frame From the time of infusion through Day 90 postinfusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Arm/Group Title AIGIV 3.5 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C)
Hide Arm/Group Description:
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Overall Number of Participants Analyzed 27 28 28
Mean (Standard Deviation)
Unit of Measure: h*NF50
323.03  (312.94) 636.31  (115.17) 1277.30  (186.41)
5.Secondary Outcome
Title Area Under the Curve to Infinity (AUC[0-inf])
Hide Description Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Time Frame From the time of infusion through Day 90 postinfusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Arm/Group Title AIGIV 3.5 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C)
Hide Arm/Group Description:
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Overall Number of Participants Analyzed 26 23 25
Mean (Standard Deviation)
Unit of Measure: h*NF50
329.01  (51.04) 698.26  (117.61) 1401.08  (216.62)
6.Secondary Outcome
Title Elimination Rate Constant
Hide Description Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Time Frame From the time of infusion through Day 90 postinfusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Arm/Group Title AIGIV 3.5 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C)
Hide Arm/Group Description:
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Overall Number of Participants Analyzed 26 23 25
Mean (Standard Deviation)
Unit of Measure: /h
0.0014  (0.0004) 0.0013  (0.0003) 0.0012  (0.0004)
7.Secondary Outcome
Title Elimination Half-life (t½)
Hide Description Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Time Frame From the time of infusion through Day 90 postinfusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Arm/Group Title AIGIV 3.5 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C)
Hide Arm/Group Description:
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Overall Number of Participants Analyzed 26 23 25
Median (Full Range)
Unit of Measure: hours
489.36
(301.12 to 1003.89)
526.36
(361.11 to 870.84)
569.98
(274.82 to 1100.34)
8.Secondary Outcome
Title Mean Residence Time (MRT)
Hide Description Blood samples for TNA analysis collected at pre-infusion; 5 minutes postinfusion; 8, 24, and 48 hours postinfusion; and Days 3, 5, 10, 14, 21, 30, 45, 60, and 90 postinfusion.
Time Frame From the time of infusion through Day 90 postinfusion.
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic ITT population: all subjects who received any infusion of AIGIV, had sufficient data for PK analysis, and had no specified protocol violations known before database lock that would be expected to affect the titer.
Arm/Group Title AIGIV 3.5 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C)
Hide Arm/Group Description:
AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion.
AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion.
Overall Number of Participants Analyzed 26 23 25
Mean (Standard Deviation)
Unit of Measure: hours
679.67  (178.07) 694.68  (184.39) 724.82  (175.58)
Time Frame From the time of infusion through Day 90.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AIGIV 3.5 mg/kg (Cohort A) Gamunex 90 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) Gamunex 180 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C) Gamunex 360 mg/kg (Cohort C)
Hide Arm/Group Description AIGIV containing 3.5 mg/kg anti-PA IgG as a single intravenous infusion. Gamunex 90 mg/kg total IgG as a single intravenous infusion. AIGIV containing 7.0 mg/kg anti-PA IgG as a single intravenous infusion. Gamunex 180 mg/kg total IgG as a single intravenous infusion. AIGIV containing 14.0 mg/kg anti-PA IgG as a single intravenous infusion. Gamunex 360 mg/kg total IgG as a single intravenous infusion.
All-Cause Mortality
AIGIV 3.5 mg/kg (Cohort A) Gamunex 90 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) Gamunex 180 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C) Gamunex 360 mg/kg (Cohort C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)      0/5 (0.00%)      0/31 (0.00%)      0/14 (0.00%)      00/29 (0.00%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
AIGIV 3.5 mg/kg (Cohort A) Gamunex 90 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) Gamunex 180 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C) Gamunex 360 mg/kg (Cohort C)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      0/5 (0.00%)      1/31 (3.23%)      1/14 (7.14%)      0/29 (0.00%)      0/16 (0.00%)    
Gastrointestinal disorders             
Abdominal pain   1/30 (3.33%)  2 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 0/16 (0.00%)  0
Infections and infestations             
Sepsis syndrome   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 1/14 (7.14%)  1 0/29 (0.00%)  0 0/16 (0.00%)  0
Injury, poisoning and procedural complications             
Gun shot wound   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 1/14 (7.14%)  1 0/29 (0.00%)  0 0/16 (0.00%)  0
Pregnancy, puerperium and perinatal conditions             
Intra-uterine death   0/30 (0.00%)  0 0/5 (0.00%)  0 1/31 (3.23%)  1 0/14 (0.00%)  0 0/29 (0.00%)  0 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AIGIV 3.5 mg/kg (Cohort A) Gamunex 90 mg/kg (Cohort A) AIGIV 7.0 mg/kg (Cohort B) Gamunex 180 mg/kg (Cohort B) AIGIV 14.0 mg/kg (Cohort C) Gamunex 360 mg/kg (Cohort C)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/30 (93.33%)      5/5 (100.00%)      29/31 (93.55%)      11/14 (78.57%)      29/29 (100.00%)      15/16 (93.75%)    
Blood and lymphatic system disorders             
Neutropenia   8/30 (26.67%)  11 1/5 (20.00%)  1 1/31 (3.23%)  1 1/14 (7.14%)  1 1/29 (3.45%)  1 0/16 (0.00%)  0
Cardiac disorders             
Bradycardia   7/30 (23.33%)  12 0/5 (0.00%)  0 3/31 (9.68%)  3 2/14 (14.29%)  5 2/29 (6.90%)  2 0/16 (0.00%)  0
Tachycardia   6/30 (20.00%)  6 1/5 (20.00%)  1 0/31 (0.00%)  0 0/14 (0.00%)  0 3/29 (10.34%)  3 0/16 (0.00%)  0
Eye disorders             
Conjunctival haemorrhage   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders             
Abdominal pain   1/30 (3.33%)  2 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 1/16 (6.25%)  1
Dyspepsia   2/30 (6.67%)  2 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 0/16 (0.00%)  0
Nausea   1/30 (3.33%)  1 0/5 (0.00%)  0 6/31 (19.35%)  7 0/14 (0.00%)  0 2/29 (6.90%)  2 2/16 (12.50%)  2
Tooth disorder   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 1/16 (6.25%)  2
Toothache   0/30 (0.00%)  0 0/5 (0.00%)  0 4/31 (12.90%)  4 1/14 (7.14%)  1 0/29 (0.00%)  0 1/16 (6.25%)  1
Vomiting   1/30 (3.33%)  1 0/5 (0.00%)  0 2/31 (6.45%)  2 0/14 (0.00%)  0 2/29 (6.90%)  2 0/16 (0.00%)  0
Stomach discomfort   0/30 (0.00%)  0 1/5 (20.00%)  1 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 0/16 (0.00%)  0
General disorders             
Chills   0/30 (0.00%)  0 0/5 (0.00%)  0 1/31 (3.23%)  1 0/14 (0.00%)  0 2/29 (6.90%)  2 1/16 (6.25%)  1
Infusion site pain   2/30 (6.67%)  2 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 1/29 (3.45%)  1 1/16 (6.25%)  1
Infusion site reaction   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 1/29 (3.45%)  1 1/16 (6.25%)  2
Pain   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 1/14 (7.14%)  1 0/29 (0.00%)  0 0/16 (0.00%)  0
Pyrexia   1/30 (3.33%)  1 0/5 (0.00%)  0 2/31 (6.45%)  2 1/14 (7.14%)  1 1/29 (3.45%)  1 0/16 (0.00%)  0
Vessel puncture site haematoma   0/30 (0.00%)  0 0/5 (0.00%)  0 3/31 (9.68%)  3 1/14 (7.14%)  1 6/29 (20.69%)  7 5/16 (31.25%)  5
Vessel puncture site pain   0/30 (0.00%)  0 0/5 (0.00%)  0 2/31 (6.45%)  2 1/14 (7.14%)  1 1/29 (3.45%)  1 0/16 (0.00%)  0
Infections and infestations             
Bacteriuria   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 2/29 (6.90%)  2 0/16 (0.00%)  0
Lower respiratory tract infection   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 1/14 (7.14%)  1 0/29 (0.00%)  0 0/16 (0.00%)  0
Nasopharyngitis   2/30 (6.67%)  2 0/5 (0.00%)  0 2/31 (6.45%)  2 1/14 (7.14%)  1 2/29 (6.90%)  2 1/16 (6.25%)  1
Tooth abscess   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 1/16 (6.25%)  1
Urinary tract infection   1/30 (3.33%)  1 0/5 (0.00%)  0 1/31 (3.23%)  1 0/14 (0.00%)  0 0/29 (0.00%)  0 1/16 (6.25%)  1
Injury, poisoning and procedural complications             
Contusion   0/30 (0.00%)  0 1/5 (20.00%)  1 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 0/16 (0.00%)  0
Investigations             
Alanine aminotransferase increased   0/30 (0.00%)  0 0/5 (0.00%)  0 1/31 (3.23%)  2 0/14 (0.00%)  0 1/29 (3.45%)  2 2/16 (12.50%)  2
Aspartate aminotransferase increased   0/30 (0.00%)  0 0/5 (0.00%)  0 1/31 (3.23%)  2 0/14 (0.00%)  0 1/29 (3.45%)  3 1/16 (6.25%)  1
Bacteria urine   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 1/16 (6.25%)  1
Blood pressure decreased   1/30 (3.33%)  1 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 2/16 (12.50%)  3
Blood pressure increased   17/30 (56.67%)  47 3/5 (60.00%)  5 20/31 (64.52%)  46 5/14 (35.71%)  5 19/29 (65.52%)  37 7/16 (43.75%)  12
Blood urine present   0/30 (0.00%)  0 0/5 (0.00%)  0 1/31 (3.23%)  1 1/14 (7.14%)  1 0/29 (0.00%)  0 1/16 (6.25%)  1
Body temperature increased   0/30 (0.00%)  0 0/5 (0.00%)  0 1/31 (3.23%)  1 0/14 (0.00%)  0 3/29 (10.34%)  6 0/16 (0.00%)  0
Heart rate decreased   1/30 (3.33%)  1 0/5 (0.00%)  0 2/31 (6.45%)  2 0/14 (0.00%)  0 7/29 (24.14%)  10 2/16 (12.50%)  2
Heart rate increased   0/30 (0.00%)  0 0/5 (0.00%)  0 7/31 (22.58%)  7 1/14 (7.14%)  1 4/29 (13.79%)  4 3/16 (18.75%)  3
Nitrite urine   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 1/16 (6.25%)  1
Protein urine   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 1/29 (3.45%)  1 1/16 (6.25%)  1
Respiratory rate increased   10/30 (33.33%)  14 0/5 (0.00%)  0 6/31 (19.35%)  7 6/14 (42.86%)  7 18/29 (62.07%)  20 8/16 (50.00%)  8
White blood cells urine positive   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 2/29 (6.90%)  2 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 1/14 (7.14%)  1 0/29 (0.00%)  0 0/16 (0.00%)  0
Back pain   0/30 (0.00%)  0 0/5 (0.00%)  0 3/31 (9.68%)  4 0/14 (0.00%)  0 2/29 (6.90%)  2 0/16 (0.00%)  0
Muscle spasms   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 1/29 (3.45%)  1 1/16 (6.25%)  1
Myalgia   0/30 (0.00%)  0 0/5 (0.00%)  0 1/31 (3.23%)  1 0/14 (0.00%)  0 1/29 (3.45%)  1 1/16 (6.25%)  1
Pain in extremity   0/30 (0.00%)  0 0/5 (0.00%)  0 1/31 (3.23%)  1 0/14 (0.00%)  0 1/29 (3.45%)  1 1/16 (6.25%)  1
Pain in jaw   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 1/14 (7.14%)  1 0/29 (0.00%)  0 0/16 (0.00%)  0
Trismus   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 1/14 (7.14%)  1 0/29 (0.00%)  0 0/16 (0.00%)  0
Nervous system disorders             
Dizziness   2/30 (6.67%)  2 0/5 (0.00%)  0 5/31 (16.13%)  5 0/14 (0.00%)  0 0/29 (0.00%)  0 2/16 (12.50%)  2
Headache   5/30 (16.67%)  7 2/5 (40.00%)  2 10/31 (32.26%)  10 3/14 (21.43%)  5 10/29 (34.48%)  12 3/16 (18.75%)  4
Psychiatric disorders             
Agitation   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 1/16 (6.25%)  1
Renal and urinary disorders             
Dysuria   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 1/16 (6.25%)  1
Haematuria   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 3/29 (10.34%)  7 0/16 (0.00%)  0
Reproductive system and breast disorders             
Dysmenorrhoea   0/30 (0.00%)  0 0/5 (0.00%)  0 2/31 (6.45%)  2 0/14 (0.00%)  0 0/29 (0.00%)  0 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough   1/30 (3.33%)  1 1/5 (20.00%)  1 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 1/16 (6.25%)  2
Pharyngolaryngeal pain   1/30 (3.33%)  1 0/5 (0.00%)  0 2/31 (6.45%)  2 0/14 (0.00%)  0 1/29 (3.45%)  1 0/16 (0.00%)  0
Sinus congestion   1/30 (3.33%)  1 1/5 (20.00%)  1 0/31 (0.00%)  0 0/14 (0.00%)  0 1/29 (3.45%)  1 0/16 (0.00%)  0
Wheezing   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 0/29 (0.00%)  0 1/16 (6.25%)  1
Skin and subcutaneous tissue disorders             
Dermatitis contact   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 0/14 (0.00%)  0 1/29 (3.45%)  1 3/16 (18.75%)  3
Vascular disorders             
Orthostatic hypotension   0/30 (0.00%)  0 0/5 (0.00%)  0 0/31 (0.00%)  0 1/14 (7.14%)  1 0/29 (0.00%)  0 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Emergent Product Development Gaithersburg, Inc.
EMail: clinicalstudies@ebsi.com
Layout table for additonal information
Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT00845650     History of Changes
Other Study ID Numbers: EBS.AIG.001
DMID 07-0067 ( Other Identifier: NIAID )
HHSN272200700034C ( Other Grant/Funding Number: NIAID )
First Submitted: February 13, 2009
First Posted: February 18, 2009
Results First Submitted: May 11, 2018
Results First Posted: June 13, 2018
Last Update Posted: July 18, 2019