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A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)

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ClinicalTrials.gov Identifier: NCT01865487
Recruitment Status : Completed
First Posted : May 31, 2013
Results First Posted : December 19, 2019
Last Update Posted : December 19, 2019
Sponsor:
Collaborator:
Statens Serum Institut
Information provided by (Responsible Party):
Aeras

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Latent Tuberculosis Bacteriology and Histology Unknown
Latent Tuberculosis
Interventions Biological: H56ug/IC31nmol
Biological: Placebo
Enrollment 98
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1: 2-dose 5/500 Group 1: 2-dose 15/500 Group 1: 2-dose 50/500 Group 1: 2-dose Placebo Group 2: 3-dose 5/500 Group 2: 3-dose Placebo Group 3: 2-dose 5/500 Group 3: 2-dose Placebo Group 4: 3-dose 5/500 Group 4: 3-dose Placebo
Hide Arm/Group Description 5/500 H56ug/IC31nmol, QFT Negative, 2 doses, days 0 and 56 15/500 H56ug/IC31nmol, QFT Negative, 2 doses, days 0 and 56 50/500 H56ug/IC31nmol, QFT Negative, 2 doses, days 0 and 56 Placebo, QFT Negative, 2 doses, days 0 and 56 5/500 H56ug/IC31nmol, QFT Negative, 3 doses, days 0, 56, 112 Placebo, QFT Negative, 3 doses, days 0, 56, 112 5/500 H56ug/IC31nmol, QFT Positive, 2 doses, Days 0 and 56 Placebo, QFT Positive, 2 doses, Days 0 and 56 5/500 H56ug/IC31nmol, QFT Positive, 3 doses, days 0, 56, 112 Placebo, QFT positive, 3 doses, Days 0, 56, 112
Period Title: Overall Study
Started 15 15 15 5 12 4 12 4 12 4
Completed 15 15 15 4 11 4 11 4 12 4
Not Completed 0 0 0 1 1 0 1 0 0 0
Reason Not Completed
Lost to Follow-up             0             0             0             1             0             0             1             0             0             0
Withdrawal by Subject             0             0             0             0             1             0             0             0             0             0
Arm/Group Title 2-Dose Placebo 2-Dose 5/500 H56/IC31nmol 2-Dose 15/500 H56/IC31nmol 2-Dose 50/500 H56/IC31nmol 3-Dose Placebo 3-Dose 5/500 H56/IC31nmol Total
Hide Arm/Group Description Placebo, QFT Neg and Pos, 2 doses day 0 and 56 5/500 H56ug/IC31nmol, QFT Neg and Pos, 2 Doses, days 0 and 56 15/500 H56ug/IC31nmol, QFT Negative, 2 Doses, days 0 and 56 50/500 H56ug/IC31nmol, QFT Negative, 2 Doses, days 0 and 56 Placebo QFT Neg and Pos, 3 Doses, days 0, 56, 112 5/500 H56ug/IC31nmol, QFT Neg and Pos, 3 Doses, days 0, 56, 112 Total of all reporting groups
Overall Number of Baseline Participants 9 27 15 15 8 24 98
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 27 participants 15 participants 15 participants 8 participants 24 participants 98 participants
27.9  (9.51) 27.2  (8.71) 24.3  (4.08) 25.3  (8.76) 24.9  (8.25) 28.4  (8.34) 26.6  (8.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 27 participants 15 participants 15 participants 8 participants 24 participants 98 participants
Female
7
  77.8%
19
  70.4%
6
  40.0%
11
  73.3%
6
  75.0%
17
  70.8%
66
  67.3%
Male
2
  22.2%
8
  29.6%
9
  60.0%
4
  26.7%
2
  25.0%
7
  29.2%
32
  32.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 27 participants 15 participants 15 participants 8 participants 24 participants 98 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%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  55.6%
9
  33.3%
6
  40.0%
7
  46.7%
3
  37.5%
8
  33.3%
38
  38.8%
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%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Coloured
4
  44.4%
18
  66.7%
9
  60.0%
8
  53.3%
5
  62.5%
16
  66.7%
60
  61.2%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 9 participants 27 participants 15 participants 15 participants 8 participants 24 participants 98 participants
26.83  (8.385) 27.11  (6.655) 25.74  (8.122) 31.14  (10.922) 27.75  (12.612) 25.56  (5.726) 27.17  (8.191)
[1]
Measure Description: Baseline Body Mass Index in kg/m^2
LTBI Status at Baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 27 participants 15 participants 15 participants 8 participants 24 participants 98 participants
LTBI Negative
5
  55.6%
15
  55.6%
15
 100.0%
15
 100.0%
4
  50.0%
12
  50.0%
66
  67.3%
LTBI Positivie
4
  44.4%
12
  44.4%
0
   0.0%
0
   0.0%
4
  50.0%
12
  50.0%
32
  32.7%
[1]
Measure Description: LTBI = Latent tuberculosis infection
1.Primary Outcome
Title Number and Percentage of Unsolicited and Solicited Adverse Events Recorded Post Day 0 Vaccination.
Hide Description Evaluation of unsolicited and solicited AEs was performed through 28 days after each study vaccination. Serious AEs were collected throughout the entire study period (i.e., 292 days). Evaluation of the safety profile of AERAS-456 was performed using data from all subjects who received at least one dose.
Time Frame Up to 10 months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title Placebo QFT Neg Placebo QFT Pos 2-Doses 5/500 QFT Neg 2-Doses 15/500 2-Doses 50/500 3-Doses 5/500 QFT Neg 2-Doses 5/500 QFT Pos 3-Doses 5/500 QFT Pos
Hide Arm/Group Description:
2-doses and 3-doses (Groups 1 and 2)
2-doses and 3-doses (Groups 3 and 4)
QFT Negative (Group 1)
QFT Negative (Group 1)
QFT Negative (Group 1)
QFT Negative (Group 2)
QFT Positive (Group 3)
QFT Positive (Group 4)
Overall Number of Participants Analyzed 9 8 15 15 15 12 12 12
Measure Type: Number
Unit of Measure: Participants
Participants with AEs 7 8 15 15 15 10 10 10
Participants with related AEs 5 4 12 11 12 6 8 8
Participants with SAEs 0 0 2 0 0 0 0 0
2.Secondary Outcome
Title Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - CD4+ ICS (LTBI-negative)
Hide Description LTBI: Latent TB Infection QFT: QuantiFERON-TB Gold Plus (QFT-Plus) is an in vitro diagnostic aid for detection of Mycobacterium tuberculosis infection Percent Antigen-specific T Cell DMSO-subtracted Cytokine Response Change from Baseline 13-color ICS assay using PBMCs T Cell: CD4+ Stimulation Antigen: Total Cytokine: Any
Time Frame Day 292
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity analysis set: LTBI-negative at baseline
Arm/Group Title 2-Dose Placebo 2-Dose 5/500 H56/IC31nmol 2-Dose 15/500 H56/IC31nmol 2-Dose 50/500 H56/IC31nmol 3-Dose Placebo 3-Dose 5/500 H56/IC31nmol
Hide Arm/Group Description:
Placebo, QFT Neg and Pos, 2 doses day 0 and 56
5/500 H56ug/IC31nmol, QFT Neg and Pos, 2 Doses, days 0 and 56
15/500 H56ug/IC31nmol, QFT Negative, 2 Doses, days 0 and 56
50/500 H56ug/IC31nmol, QFT Negative, 2 Doses, days 0 and 56
Placebo QFT Neg and Pos, 3 Doses, days 0, 56, 112
5/500 H56ug/IC31nmol, QFT Neg and Pos, 3 Doses, days 0, 56, 112
Overall Number of Participants Analyzed 4 13 14 14 3 6
Mean (Standard Deviation)
Unit of Measure: Percentage of change from baseline
0.002  (0.018) 0.088  (0.104) 0.027  (0.031) 0.031  (0.047) 0.012  (0.014) 0.045  (0.056)
3.Secondary Outcome
Title Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - CD4+ ICS (LTBI-positive)
Hide Description

Percent Antigen-specific T Cell DMSO-subtracted Cytokine Response Change from Baseline.

13-color ICS assay using PBMCs. T Cell: CD4+ Stimulation Antigen: Total Cytokine: Any

Time Frame Day 292
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity analysis set: LTBI-positive at baseline
Arm/Group Title 2-Dose Placebo 2-Dose 5/500 H56/IC31nmol 3-Dose Placebo 3-Dose 5/500 H56/IC31nmol
Hide Arm/Group Description:
Placebo, QFT Neg and Pos, 2 doses day 0 and 56
5/500 H56ug/IC31nmol, QFT Neg and Pos, 2 Doses, days 0 and 56
Placebo QFT Neg and Pos, 3 Doses, days 0, 56, 112
5/500 H56ug/IC31nmol, QFT Neg and Pos, 3 Doses, days 0, 56, 112
Overall Number of Participants Analyzed 4 10 4 8
Mean (Standard Deviation)
Unit of Measure: Percentage of change from baseline
0.005  (0.020) 0.068  (0.052) 0.027  (0.022) 0.097  (0.170)
4.Secondary Outcome
Title Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - IFN-gamma ELISpot
Hide Description DMSO-subtracted Antigen-specific IFN-gamma ELISpot Response (SFU - Background/10^6 PBMC) Change from Baseline LTBI Status at Baseline: Total Stimulation Antigen: Total
Time Frame Day 292
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity analysis set
Arm/Group Title 2-Dose Placebo 2-Dose 5/500 H56/IC31nmol 2-Dose 15/500 H56/IC31nmol 2-Dose 50/500 H56/IC31nmol 3-Dose Placebo 3-Dose 5/500 H56/IC31nmol
Hide Arm/Group Description:
Placebo, QFT Neg and Pos, 2 doses day 0 and 56
5/500 H56ug/IC31nmol, QFT Neg and Pos, 2 Doses, days 0 and 56
15/500 H56ug/IC31nmol, QFT Negative, 2 Doses, days 0 and 56
50/500 H56ug/IC31nmol, QFT Negative, 2 Doses, days 0 and 56
Placebo QFT Neg and Pos, 3 Doses, days 0, 56, 112
5/500 H56ug/IC31nmol, QFT Neg and Pos, 3 Doses, days 0, 56, 112
Overall Number of Participants Analyzed 8 21 13 12 7 13
Mean (Standard Deviation)
Unit of Measure: Number of spots per well
82.7  (223.6) 209.0  (221.8) 57.9  (162.2) 110.0  (92.0) -53.1  (79.8) 167.4  (364.8)
5.Secondary Outcome
Title Evaluate Kinetics of QuantiFERON®-TB Gold Test (QFT) Responses in LTBI-negative Participants
Hide Description

QFT results were summarized using subject count (percentage) for qualitative results.

Number of participants QFT-positive at any time point.

Time Frame Up to Study Day 292
Hide Outcome Measure Data
Hide Analysis Population Description
Conversion of LTBI-negative at baseline to LTBI-positive due to H56:IC31 expression of ESAT-6 (antigen in QFT assay).
Arm/Group Title Placebo QFT Neg 2-Doses 5/500 QFT Neg 2-Doses 15/500 2-Doses 50/500 3-Doses 5/500 QFT Neg
Hide Arm/Group Description:
2-doses and 3-doses (Groups 1 and 2)
QFT Negative (Group 1)
QFT Negative (Group 1)
QFT Negative (Group 1)
QFT Negative (Group 2)
Overall Number of Participants Analyzed 9 15 15 15 12
Measure Type: Count of Participants
Unit of Measure: Participants
2
  22.2%
7
  46.7%
6
  40.0%
6
  40.0%
7
  58.3%
Time Frame 10 months
Adverse Event Reporting Description Systematic Assessment - includes diary cards, scheduled visits and lab tests Non-systematic Assessment also collected through self reporting
 
Arm/Group Title 2-Dose Placebo 2-Dose 5/500 H56ug/IC31nmol 2-Dose 15/500 H56ug/IC31nmol 2-Dose 50/500 H56ug/IC31nmol 3-Dose Placebo 3-Dose 5/500 H56ug/IC31nmol
Hide Arm/Group Description Placebo QFT neg and pos 2-Dose 5/500 H56ug/IC31nmol, QFT neg and pos 2-Dose 15/500 H56ug/IC31nmol, QFT negative 2-Dose 50/500 H56ug/IC31nmol, QFT negative 3-Dose Placebo QFT neg and pos 3-Dose 5/500 H56ug/IC31nmol, QFT neg and pos
All-Cause Mortality
2-Dose Placebo 2-Dose 5/500 H56ug/IC31nmol 2-Dose 15/500 H56ug/IC31nmol 2-Dose 50/500 H56ug/IC31nmol 3-Dose Placebo 3-Dose 5/500 H56ug/IC31nmol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      0/27 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/8 (0.00%)      0/24 (0.00%)    
Hide Serious Adverse Events
2-Dose Placebo 2-Dose 5/500 H56ug/IC31nmol 2-Dose 15/500 H56ug/IC31nmol 2-Dose 50/500 H56ug/IC31nmol 3-Dose Placebo 3-Dose 5/500 H56ug/IC31nmol
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   0/9 (0.00%)      2/27 (7.41%)      0/15 (0.00%)      0/15 (0.00%)      0/8 (0.00%)      0/24 (0.00%)    
Injury, poisoning and procedural complications             
Pneumothorax traumatic  1  0/9 (0.00%)  0 1/27 (3.70%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/24 (0.00%)  0
Nervous system disorders             
Lumbar radiculopathy  1  0/9 (0.00%)  0 1/27 (3.70%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/24 (0.00%)  0
1
Term from vocabulary, MedDRA 16.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2-Dose Placebo 2-Dose 5/500 H56ug/IC31nmol 2-Dose 15/500 H56ug/IC31nmol 2-Dose 50/500 H56ug/IC31nmol 3-Dose Placebo 3-Dose 5/500 H56ug/IC31nmol
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   9/9 (100.00%)      25/27 (92.59%)      15/15 (100.00%)      15/15 (100.00%)      6/8 (75.00%)      20/24 (83.33%)    
Cardiac disorders             
Bradycardia  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/8 (12.50%)  1 0/24 (0.00%)  0
Gastrointestinal disorders             
Abdominal pain  1  0/9 (0.00%)  0 1/27 (3.70%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/24 (0.00%)  0
Diarrhoea  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/24 (0.00%)  0
Nausea  1  1/9 (11.11%)  1 1/27 (3.70%)  1 2/15 (13.33%)  2 3/15 (20.00%)  4 0/8 (0.00%)  0 2/24 (8.33%)  2
Toothache  1  0/9 (0.00%)  0 0/27 (0.00%)  0 1/15 (6.67%)  1 1/15 (6.67%)  1 1/8 (12.50%)  1 0/24 (0.00%)  0
Vomiting  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/24 (0.00%)  0
General disorders             
Chills  1  0/9 (0.00%)  0 0/27 (0.00%)  0 1/15 (6.67%)  1 4/15 (26.67%)  4 1/8 (12.50%)  1 1/24 (4.17%)  1
Fatigue  1  3/9 (33.33%)  3 5/27 (18.52%)  5 3/15 (20.00%)  6 5/15 (33.33%)  7 2/8 (25.00%)  3 1/24 (4.17%)  1
Injection site erythema  1  0/9 (0.00%)  0 2/27 (7.41%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 1/24 (4.17%)  1
Injection site pain  1  2/9 (22.22%)  2 14/27 (51.85%)  19 5/15 (33.33%)  10 8/15 (53.33%)  11 1/8 (12.50%)  1 7/24 (29.17%)  12
Injection site swelling  1  0/9 (0.00%)  0 2/27 (7.41%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 1/24 (4.17%)  1
Injection site warmth  1  0/9 (0.00%)  0 1/27 (3.70%)  1 0/15 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/24 (0.00%)  0
Malaise  1  0/9 (0.00%)  0 1/27 (3.70%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 1/24 (4.17%)  1
Pyrexia  1  0/9 (0.00%)  0 1/27 (3.70%)  1 1/15 (6.67%)  1 1/15 (6.67%)  1 1/8 (12.50%)  1 1/24 (4.17%)  1
Immune system disorders             
Seasonal allergy  1  0/9 (0.00%)  0 0/27 (0.00%)  0 1/15 (6.67%)  3 1/15 (6.67%)  1 0/8 (0.00%)  0 1/24 (4.17%)  1
Infections and infestations             
Gastroenteritis  1  0/9 (0.00%)  0 1/27 (3.70%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/24 (0.00%)  0
Influenza  1  0/9 (0.00%)  0 1/27 (3.70%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 1/8 (12.50%)  2 1/24 (4.17%)  1
Pharyngitis  1  0/9 (0.00%)  0 2/27 (7.41%)  2 0/15 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 1/24 (4.17%)  1
Sinusitis  1  0/9 (0.00%)  0 2/27 (7.41%)  2 0/15 (0.00%)  0 2/15 (13.33%)  3 0/8 (0.00%)  0 1/24 (4.17%)  1
Upper respiratory tract infection  1  1/9 (11.11%)  1 1/27 (3.70%)  1 0/15 (0.00%)  0 2/15 (13.33%)  2 0/8 (0.00%)  0 1/24 (4.17%)  1
Urinary tract infection  1  2/9 (22.22%)  2 0/27 (0.00%)  0 2/15 (13.33%)  2 2/15 (13.33%)  2 1/8 (12.50%)  1 2/24 (8.33%)  3
Wound infection  1  0/9 (0.00%)  0 1/27 (3.70%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/24 (0.00%)  0
Injury, poisoning and procedural complications             
Contusion  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/8 (12.50%)  1 0/24 (0.00%)  0
Stab wound  1  0/9 (0.00%)  0 0/27 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/8 (0.00%)  0 0/24 (0.00%)  0
Investigations             
Alanine aminotransferase increased  1  2/9 (22.22%)  2 1/27 (3.70%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 3/24 (12.50%)  3
Aspartate aminotransferase increased  1  0/9 (0.00%)  0 1/27 (3.70%)  1 1/15 (6.67%)  1 0/15 (0.00%)  0 0/8 (0.00%)  0 2/24 (8.33%)  2
Blood alkaline phosphatase increased  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 2/15 (13.33%)  2 0/8 (0.00%)  0 0/24 (0.00%)  0
Blood bilirubin increased  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/8 (12.50%)  1 0/24 (0.00%)  0
Blood pressure diastolic increased  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/24 (0.00%)  0
Blood pressure increased  1  0/9 (0.00%)  0 1/27 (3.70%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 1/8 (12.50%)  1 2/24 (8.33%)  3
Blood pressure systolic decreased  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 1/24 (4.17%)  1
Blood pressure systolic increased  1  0/9 (0.00%)  0 3/27 (11.11%)  4 2/15 (13.33%)  2 2/15 (13.33%)  2 2/8 (25.00%)  3 3/24 (12.50%)  4
Blood urine present  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/8 (12.50%)  1 1/24 (4.17%)  1
Haemoglobin decreased  1  0/9 (0.00%)  0 3/27 (11.11%)  4 1/15 (6.67%)  1 0/15 (0.00%)  0 0/8 (0.00%)  0 1/24 (4.17%)  1
Heart rate decreased  1  0/9 (0.00%)  0 0/27 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/8 (0.00%)  0 0/24 (0.00%)  0
Lymphocyte count decreased  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 1/24 (4.17%)  1
Neutrophil count decreased  1  1/9 (11.11%)  1 1/27 (3.70%)  1 0/15 (0.00%)  0 3/15 (20.00%)  3 1/8 (12.50%)  1 1/24 (4.17%)  1
Platelet count decreased  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 1/24 (4.17%)  1
Respiratory rate increased  1  3/9 (33.33%)  5 13/27 (48.15%)  25 13/15 (86.67%)  21 11/15 (73.33%)  19 0/8 (0.00%)  0 1/24 (4.17%)  1
White blood cell count decreased  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 1/24 (4.17%)  1
White blood cell count increased  1  0/9 (0.00%)  0 1/27 (3.70%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 1/24 (4.17%)  1
White blood cells urine positive  1  1/9 (11.11%)  1 0/27 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/24 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Arthralgia  1  2/9 (22.22%)  2 1/27 (3.70%)  1 1/15 (6.67%)  1 2/15 (13.33%)  3 0/8 (0.00%)  0 0/24 (0.00%)  0
Back pain  1  1/9 (11.11%)  1 1/27 (3.70%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/24 (0.00%)  0
Musculoskeletal chest pain  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/24 (0.00%)  0
Myalgia  1  0/9 (0.00%)  0 4/27 (14.81%)  4 5/15 (33.33%)  6 2/15 (13.33%)  2 2/8 (25.00%)  2 2/24 (8.33%)  3
Neck pain  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/24 (0.00%)  0
Pain in extremity  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 1/24 (4.17%)  1
Nervous system disorders             
Dizziness  1  1/9 (11.11%)  1 0/27 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 1/24 (4.17%)  1
Headache  1  1/9 (11.11%)  1 4/27 (14.81%)  7 2/15 (13.33%)  2 4/15 (26.67%)  4 1/8 (12.50%)  1 4/24 (16.67%)  4
Renal and urinary disorders             
Glycosuria  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 0/24 (0.00%)  0
Haematuria  1  1/9 (11.11%)  1 1/27 (3.70%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 0/24 (0.00%)  0
Proteinuria  1  0/9 (0.00%)  0 2/27 (7.41%)  3 0/15 (0.00%)  0 1/15 (6.67%)  1 0/8 (0.00%)  0 2/24 (8.33%)  2
Skin and subcutaneous tissue disorders             
Papule  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 1/24 (4.17%)  1
Vascular disorders             
Systolic hypertension  1  0/9 (0.00%)  0 0/27 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/8 (0.00%)  0 1/24 (4.17%)  1
1
Term from vocabulary, MedDRA 16.0
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
Layout table for Results Point of Contact information
Name/Title: Dr. Dereck Tait
Organization: Aeras
Phone: 27214424991
EMail: dtait@aeras.org
Layout table for additonal information
Responsible Party: Aeras
ClinicalTrials.gov Identifier: NCT01865487    
Other Study ID Numbers: C-035-456
First Submitted: May 21, 2013
First Posted: May 31, 2013
Results First Submitted: April 23, 2019
Results First Posted: December 19, 2019
Last Update Posted: December 19, 2019