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Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.

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ClinicalTrials.gov Identifier: NCT00248833
Recruitment Status : Completed
First Posted : November 4, 2005
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Meningitis, Meningococcal, Serogroup B
Interventions Biological: 25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine
Biological: 50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine
Enrollment 34
Recruitment Details 34 subjects were enrolled to be randomized into 1 of 3 cohorts at the WRAIR CTC.
Pre-assignment Details  
Arm/Group Title 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
Hide Arm/Group Description

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Period Title: Overall Study
Started 12 11 11
Completed 9 8 9
Not Completed 3 3 2
Reason Not Completed
Adverse Event             2             0             0
Withdrawal by Subject             0             1             1
Lost to Follow-up             1             1             1
Other             0             1             0
Arm/Group Title 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant Total
Hide Arm/Group Description

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 12 11 11 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 11 participants 11 participants 34 participants
31.6  (9.3) 33.4  (7.6) 29.9  (8.4) 31.6  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 11 participants 34 participants
Female
6
  50.0%
6
  54.5%
5
  45.5%
17
  50.0%
Male
6
  50.0%
5
  45.5%
6
  54.5%
17
  50.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 11 participants 34 participants
White
7
  58.3%
5
  45.5%
4
  36.4%
16
  47.1%
Black or African American
5
  41.7%
7
  63.6%
7
  63.6%
19
  55.9%
Hispanic or Latino
1
   8.3%
1
   9.1%
1
   9.1%
3
   8.8%
Asian
1
   8.3%
0
   0.0%
0
   0.0%
1
   2.9%
[1]
Measure Description: There is discrepancy in the demographic data within the Final Clinical Study Report (FCSR). Number of subject for 1) 25ug states total number of 12 subjects analyzed, but the race data indicates 13 subjects. Number of subjects for 2) 25ug states total number of 11 subjects analyzed, but the race data indicates 12 subjects analyzed. Data must me entered as indicated in the FCSR.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 11 participants 11 participants 34 participants
12 11 11 34
1.Primary Outcome
Title Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Hide Description Solicited and unsolicited summary of severity of adverse events (AEs) during the 7 day follow-up period after each vaccination
Time Frame 7 day f/u period after each vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
Hide Arm/Group Description:

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Overall Number of Participants Analyzed 12 11 11
Measure Type: Number
Unit of Measure: AEs
Solicited: Mild 67 92 70
Solicited: Moderate 3 16 10
Solicited: Not related to study drug 8 3 6
Solicited: Related to study drug 62 105 74
Unsolicited: Number of subjects with atleast 1 AE 10 10 7
Unsolicited: Mild 36 19 14
Unsolicited: Moderate 7 2 5
Unsolicited: Severe 4 2 2
Unsolicited: Not related to study drug 42 21 21
Unsolicited: Related to study drug 5 2 0
2.Primary Outcome
Title Safety: Adverse Event Type Summarized by Dose
Hide Description Adverse events summarized by type and dose
Time Frame 7 days after each vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Both 25ug groups (1 and 2) were grouped for this analysis as both groups received the same dosage
Arm/Group Title 25ug Group B Meningococcal 44/76 MOS NOMV 5D 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
Hide Arm/Group Description:

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with and without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Overall Number of Participants Analyzed 23 11
Measure Type: Number
Unit of Measure: Number of AEs
Blood and lymphatic system disorders 2 0
Gastrointestinal disorders 3 0
General disorders 65 75
Infection and infestations 5 7
Injury, poisoning and procedural complications 4 0
Investigations 8 1
Metabolism and nutrition disorders 2 0
Musculoskeletal and connective tissue disorders 8 8
Nervous system disorders 11 10
Renal and urinary disorders 5 0
Respiratory, thoracic and mediastinal disorders 3 0
Skin and subcutaneous tissue disorders 1 0
3.Secondary Outcome
Title Weeks to Serconversion
Hide Description Weeks to seroconversion evaluated by serum bactericidal assay. Immunogenicity was determined by assessing the number of subjects, in each cohort, who seroconverted. Seroconversion was defined as a 4-fold or greater increase in serum bactericidal antibodies against the vaccine strain. The geometric mean bactericidal titer (GMT) for each group was determined prior to vaccination and at 2 weeks after each vaccination. For each group, the GMT ratio relative to baseline and after 1, 2, or 3 vaccinations and the 95% 2-sided confidence interval was determined. A seroconversion of ≥50% of the subjects after 2 or more doses would meet the criteria for further vaccine development.
Time Frame 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number analyzed are subjects that seroconverted
Arm/Group Title 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
Hide Arm/Group Description:

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Overall Number of Participants Analyzed 9 12 13
Mean (Standard Deviation)
Unit of Measure: Weeks
Test Antigen: 44/76 Number Analyzed 6 participants 5 participants 6 participants
2.0  (0.0) 4.0  (4.5) 3.0  (2.4)
Test Antigen: 8570 Number Analyzed 1 participants 1 participants 2 participants
8.0  (0.0) 8.0  (0.0) 8.0  (0.0)
Test Antigen: 9162 Number Analyzed 1 participants 2 participants 2 participants
26.0  (0.0) 8.0  (0.0) 8.0  (0.0)
Test Antigen: 44/76 P Number Analyzed 1 participants 4 participants 3 participants
8.0  (0.0) 12.5  (9.0) 8.0  (0.0)
4.Secondary Outcome
Title Percentage of Subjects With 2-fold and 4-fold Increase IgG Antibody Conversion
Hide Description Percentage of subjects with ELISA 2-fold and 4-fold increase from baseline IgG antibody Conversion
Time Frame 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed represents subjects who experienced increases from baseline
Arm/Group Title 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
Hide Arm/Group Description:

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Overall Number of Participants Analyzed 10 9 10
Measure Type: Number
Unit of Measure: % of subjects
2-fold increase from BL: 44/76 NOMV IgG 80.0 88.9 100.0
2-fold increase from BL: L3, 7 LOS 30.0 66.7 60.0
2-fold increase from BL: GNA1870 0.0 66.7 50.0
2-fold increase from BL: Opc 60.0 33.3 80.0
2-fold increase from BL: 44/76 P 60.0 77.8 80.0
4-fold increase from BL: 44/76 NOMV IgG 20.0 55.6 70.0
4-fold increase from BL: L3, 7 LOS 10.0 22.2 10.0
4-fold increase from BL: GNA1870 0.0 11.1 10.0
4-fold increase from BL: Opc 20.0 22.2 20.0
4-fold increase from BL: 44/76 P 40.0 22.2 50.0
Time Frame 7 days after each vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
Hide Arm/Group Description

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 25ug Group B Meningococcal 44/76 MOS NOMV 5D with AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

25ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 25µg with and without adjuvant were administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

Subjects received 50ug Group B Meningococcal 44/76 MOS NOMV 5D without AI (OH)3 adjuvant intramuscularly at 0, 6, and 24 weeks.

50ug Group B Meningococcal 44/76 MOS NOMV 5D Vaccine: The study was conducted as a phase 1, outpatient, dose-escalating study for the Meningococcal 44/76 MOS NOMV 5D Vaccine (lot number 1119). 50µg without adjuvant was administered. Vaccinations were given intramuscularly at 0, 6, and 24 weeks.

All-Cause Mortality
1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/11 (0.00%)      0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/11 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1) 25ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant 2) 25ug Group B Meningococcal 44/76 MOS NOMV 5D With Adjuvant 3) 50ug Group B Meningococcal 44/76 MOS NOMV 5D w/o Adjuvant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/12 (100.00%)      11/11 (100.00%)      11/11 (100.00%)    
Blood and lymphatic system disorders       
Eosinophilia * 1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Hypochromasia * 1  2/12 (16.67%)  2 0/11 (0.00%)  0 0/11 (0.00%)  0
Endocrine disorders       
Hypothyroidism * 1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Gastrointestinal disorders       
Diarrhea * 1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Gastrointestinal disorder * 1  2/12 (16.67%)  2 0/11 (0.00%)  0 0/11 (0.00%)  0
Nausea * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
General disorders       
Pain  1  12/12 (100.00%)  22 11/11 (100.00%)  52 11/11 (100.00%)  31
Swelling  1  5/12 (41.67%)  5 8/11 (72.73%)  8 7/11 (63.64%)  7
Pain lifting arm  1  8/12 (66.67%)  8 11/11 (100.00%)  17 11/11 (100.00%)  13
Warmth  1  0/12 (0.00%)  0 3/11 (27.27%)  3 1/11 (9.09%)  1
Induration  1  2/12 (16.67%)  2 1/11 (9.09%)  1 1/11 (9.09%)  1
Fatigue * 1  3/12 (25.00%)  3 1/11 (9.09%)  1 2/11 (18.18%)  2
Malaise * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 1/11 (9.09%)  1
Pyrexia * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Infections and infestations       
Diverticulitis * 1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Lyme disease * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 1/11 (9.09%)  1
Rhinitis * 1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Sinusitis * 1  1/12 (8.33%)  1 1/11 (9.09%)  1 0/11 (0.00%)  0
Upper respiratory tract infection * 1  3/12 (25.00%)  3 3/11 (27.27%)  3 5/11 (45.45%)  5
Urinary tract infection * 1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
Viral infection * 1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Injury, poisoning and procedural complications       
Tenderness  1  12/12 (100.00%)  17 11/11 (100.00%)  28 11/11 (100.00%)  21
Bruise  1  2/12 (16.67%)  2 0/11 (0.00%)  0 1/11 (9.09%)  1
Chest injury * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Neck injury * 1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Thermal burn * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Upper limb fracture * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Wound * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Investigations       
Alanine aminotransferase increased * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Blood bilirubin inconjugated increated * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Blood pressure increased * 1  2/12 (16.67%)  2 0/11 (0.00%)  0 0/11 (0.00%)  0
Haemoglobin decreased * 1  2/12 (16.67%)  2 2/11 (18.18%)  2 1/11 (9.09%)  1
Haptoglobin increased * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Liver function test abnormal * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite * 1  1/12 (8.33%)  1 1/11 (9.09%)  1 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  2/12 (16.67%)  2 1/11 (9.09%)  1 1/11 (9.09%)  1
Arthritis * 1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Back pain * 1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
Myalgia * 1  2/12 (16.67%)  2 0/11 (0.00%)  0 1/11 (9.09%)  1
Pain in extremity * 1  0/12 (0.00%)  0 0/11 (0.00%)  0 1/11 (9.09%)  1
Shoulder pain * 1  1/12 (8.33%)  1 1/11 (9.09%)  1 0/11 (0.00%)  0
Nervous system disorders       
Disturbance in attention * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Dizziness * 1  2/12 (16.67%)  2 0/11 (0.00%)  0 0/11 (0.00%)  0
Dysgeusia * 1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
Headache * 1  2/12 (16.67%)  2 3/11 (27.27%)  3 6/11 (54.55%)  6
Renal and urinary disorders       
Glycosuria * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Proteinuria * 1  4/12 (33.33%)  4 0/11 (0.00%)  0 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Nasal congestion * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Rhinorrhoea * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Sinus congestion * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Skin and subcutaneous tissue disorders       
Erythema  1  7/12 (58.33%)  7 9/11 (81.82%)  9 5/11 (45.45%)  5
Urticaria * 1  1/12 (8.33%)  1 0/11 (0.00%)  0 0/11 (0.00%)  0
Vascular disorders       
Hypertension * 1  0/12 (0.00%)  0 1/11 (9.09%)  1 0/11 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Paul B. Keiser
Organization: WRAIR
Phone: 866-856-3259
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00248833     History of Changes
Other Study ID Numbers: WRAIR 1178
HSRRB A-13513
First Submitted: November 2, 2005
First Posted: November 4, 2005
Results First Submitted: March 30, 2017
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018