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Leprosy Skin Test Antigens Trial

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ClinicalTrials.gov Identifier: NCT00128193
Recruitment Status : Completed
First Posted : August 9, 2005
Results First Posted : November 1, 2010
Last Update Posted : December 24, 2014
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Diagnostic
Condition Leprosy
Interventions Biological: Tuberculin, Purified Protein Derivative
Other: MLSA-LAM
Other: MLCwA
Other: Placebo
Enrollment 260

Recruitment Details Stage A (10) and B (90) participants were recruited from Lalitpur Nursing Campus in Kathmandu, Nepal. All participants for stages C1 (80) and C1b (80) were recruited from either Anandaban Hospital in Kathmandu, Nepal or Patan Hospital in Lalitpur, Nepal. Enrollment occurred between 30Apr2002 and 12Aug2009.
Pre-assignment Details  
Arm/Group Title A1 - MLSA in Healthy Non-Exposed Participants A2 - MLC in Healthy Non-Exposed Participants B1 - MLSA in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description 5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl) 5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl) 45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl) 45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl) 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23. 20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23. 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Period Title: Overall Study
Started 5 5 45 45 20 20 20 20 20 20 20 20
Completed 5 5 42 44 18 17 16 20 18 18 17 18
Not Completed 0 0 3 1 2 3 4 0 2 2 3 2
Arm/Group Title A1 - MLSA in Healthy Non-Exposed Participants A2 - MLC in Healthy Non-Exposed Participants B1 - MLSA in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients Total
Hide Arm/Group Description 5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl) 5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl) 45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl) 45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl) 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23. 20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23. 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23. Total of all reporting groups
Overall Number of Baseline Participants 5 5 45 45 20 20 20 20 20 20 20 20 260
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 45 participants 45 participants 20 participants 20 participants 20 participants 20 participants 20 participants 20 participants 20 participants 20 participants 260 participants
<=18 years
0
   0.0%
0
   0.0%
13
  28.9%
10
  22.2%
0
   0.0%
0
   0.0%
0
   0.0%
4
  20.0%
0
   0.0%
1
   5.0%
4
  20.0%
1
   5.0%
33
  12.7%
Between 18 and 65 years
5
 100.0%
5
 100.0%
32
  71.1%
35
  77.8%
20
 100.0%
20
 100.0%
20
 100.0%
16
  80.0%
20
 100.0%
19
  95.0%
16
  80.0%
19
  95.0%
227
  87.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 45 participants 45 participants 20 participants 20 participants 20 participants 20 participants 20 participants 20 participants 20 participants 20 participants 260 participants
30.6  (6.4) 29.4  (2.9) 21.1  (5.3) 23.1  (6.7) 37.5  (12.3) 32.9  (12.9) 32.9  (11.0) 26.0  (7.7) 35.2  (13.1) 39.0  (13.5) 30.2  (12.1) 31.1  (13.1) 28.5  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 45 participants 45 participants 20 participants 20 participants 20 participants 20 participants 20 participants 20 participants 20 participants 20 participants 260 participants
Female
4
  80.0%
4
  80.0%
14
  31.1%
8
  17.8%
6
  30.0%
6
  30.0%
7
  35.0%
7
  35.0%
5
  25.0%
4
  20.0%
14
  70.0%
5
  25.0%
84
  32.3%
Male
1
  20.0%
1
  20.0%
31
  68.9%
37
  82.2%
14
  70.0%
14
  70.0%
13
  65.0%
13
  65.0%
15
  75.0%
16
  80.0%
6
  30.0%
15
  75.0%
176
  67.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Nepal Number Analyzed 5 participants 5 participants 45 participants 45 participants 20 participants 20 participants 20 participants 20 participants 20 participants 20 participants 20 participants 20 participants 260 participants
5 5 45 45 20 20 20 20 20 20 20 20 260
1.Primary Outcome
Title Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram
Hide Description Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable erythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.
Time Frame Up to 28 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received the antigen are included in the analysis population.
Arm/Group Title A1 - MLSA in Healthy Non-Exposed Participants B1 - MLSA in Healthy Non-Exposed Participants C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 5 45 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
Erythema 0 3 1 5 4 2
Induration 0 2 0 4 2 0
Pain/Tenderness 0 1 0 0 1 0
Bleeding 0 0 0 0 1 0
Urticaria 0 0 0 0 1 0
Infection 0 0 0 0 1 0
Blistering/Ulcerating 0 0 0 0 1 0
2.Primary Outcome
Title Number of Participants With the Reaction of Itching to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram
Hide Description Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.
Time Frame Up to 28 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in Groups B and C who received the antigen are included in the analysis population.
Arm/Group Title B1 - MLSA in Healthy Non-Exposed Participants C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 45 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
0 0 1 1 0
3.Primary Outcome
Title Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram
Hide Description Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.
Time Frame Up to 28 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received the antigen are included in the analysis population.
Arm/Group Title A1 - MLSA in Healthy Non-Exposed Participants B1 - MLSA in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Overall Number of Participants Analyzed 5 45 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
Erythema 4 10 2 4 11 12
Induration 1 12 1 2 5 7
Pain/Tenderness 0 3 1 0 1 0
Bleeding 0 0 0 0 0 0
Urticaria 0 0 0 0 0 1
Infection 0 0 0 0 0 1
Blistering/Ulcerating 0 0 0 0 0 1
4.Primary Outcome
Title Number of Participants With the Reaction of Itching to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram
Hide Description Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.
Time Frame Up to 28 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in Groups B and C who received the antigen are included in the analysis population.
Arm/Group Title B1 - MLSA in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Overall Number of Participants Analyzed 45 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
0 0 0 4 1
5.Primary Outcome
Title Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram
Hide Description Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.
Time Frame Up to 28 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received the antigen are included in the analysis population.
Arm/Group Title A2 - MLC in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 5 45 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
Erythema 0 1 1 8 5 5
Induration 0 1 0 5 5 3
Pain/Tenderness 0 0 0 0 0 0
Bleeding 0 0 0 0 0 0
Urticaria 0 0 0 0 0 0
Infection 0 0 0 0 0 0
Blistering/Ulcerating 0 0 0 0 0 0
6.Primary Outcome
Title Number of Participants With Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram
Hide Description Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.
Time Frame Up to 28 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title B2 - MLC in Healthy Non-Exposed Participants C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 45 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
0 0 2 1 0
7.Primary Outcome
Title Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram
Hide Description Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.
Time Frame Up to 28 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received the antigen are included in the analysis population.
Arm/Group Title A2 - MLC in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Overall Number of Participants Analyzed 5 45 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
Erythema 3 11 2 5 8 14
Induration 1 10 0 3 9 9
Pain/Tenderness 0 0 1 1 1 2
Bleeding 0 0 0 0 0 0
Urticaria 0 0 0 0 0 0
Infection 0 0 0 0 0 0
Blistering/Ulcerating 0 0 0 0 0 0
8.Primary Outcome
Title Number of Participants With the Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram
Hide Description Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.
Time Frame Up to 28 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in Groups B and C who received the antigen are included in the analysis population.
Arm/Group Title B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Overall Number of Participants Analyzed 45 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
1 0 1 5 6
9.Primary Outcome
Title Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD)
Hide Description Participants returned to the clinic at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups), for reader measurements of erythema and induration and assessment of other adverse events of pain/tenderness, bleeding, urticaria, infection, or blistering/ulcerating. Participants are counted if they had any measurable eythema or induration, or reported any of the other listed adverse events. Reactions were reported as present or absent, and were not graded for severity.
Time Frame Up to 28 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received the antigen are included in the analysis population.
Arm/Group Title A1 - MLSA in Healthy Non-Exposed Participants A2 - MLC in Healthy Non-Exposed Participants B1 - MLSA in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 5 5 45 45 20 20 20 20 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
Erythema 5 4 33 33 12 13 17 20 9 14 17 20
Induration 5 4 33 31 11 11 16 18 11 11 16 18
Pain/Tenderness 1 2 12 13 6 7 5 9 3 1 3 3
Bleeding 0 0 0 0 0 0 0 0 0 0 0 0
Urticaria 1 2 0 1 0 0 0 0 0 0 0 0
Infection 0 0 0 0 0 0 0 0 0 0 0 0
Blistering/Ulcerating 1 0 0 4 2 0 1 0 0 0 1 0
10.Primary Outcome
Title Number of Participants With the Reaction of Itching to the Antigen Purified Protein Derivative (PPD)
Hide Description Itching was assessed for participants in Groups B and C only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present. Itching was reported as present or absent, and not graded for severity.
Time Frame Up to 28 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in Groups B and C who received the antigen are included in the analysis population.
Arm/Group Title B1 - MLSA in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 45 45 20 20 20 20 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
17 17 5 5 9 14 0 8 5 12
11.Primary Outcome
Title Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms
Hide Description If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.
Time Frame Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.
Arm/Group Title C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 5 4 2
Mean (Standard Deviation)
Unit of Measure: Millimeters
12.6  (4.2) 9.8  (1.8) 9.3  (0.6)
12.Primary Outcome
Title Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms
Hide Description If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.
Arm/Group Title C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 4 3 3
Mean (Standard Deviation)
Unit of Measure: Millimeters
11.3  (3.4) 10.3  (0.8) 9.8  (2.4)
13.Primary Outcome
Title Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms
Hide Description If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.
Time Frame Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.
Arm/Group Title C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Overall Number of Participants Analyzed 1 2 7 8
Mean (Standard Deviation)
Unit of Measure: Millimeters
20.0 23.3  (4.6) 13.0  (5.9) 14.8  (6.5)
14.Primary Outcome
Title Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms
Hide Description If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.
Arm/Group Title C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Overall Number of Participants Analyzed 1 2 9 10
Mean (Standard Deviation)
Unit of Measure: Millimeters
16.0 20.3  (5.3) 13.8  (6.6) 14.3  (6.6)
15.Primary Outcome
Title Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms
Hide Description If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.
Time Frame Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.
Arm/Group Title C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 7 6 5
Mean (Standard Deviation)
Unit of Measure: Millimeters
15.1  (3.3) 13.0  (4.6) 9.6  (2.3)
16.Primary Outcome
Title Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms
Hide Description If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.
Arm/Group Title C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 5 6 4
Mean (Standard Deviation)
Unit of Measure: Millimeters
12.1  (5.0) 12.2  (3.4) 8.9  (1.4)
17.Primary Outcome
Title Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
Hide Description If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.
Time Frame Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.
Arm/Group Title C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Overall Number of Participants Analyzed 1 3 9 11
Mean (Standard Deviation)
Unit of Measure: Millimeters
9.0 20.8  (2.9) 14.7  (5.7) 15.0  (6.1)
18.Primary Outcome
Title Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
Hide Description If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.
Arm/Group Title C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Overall Number of Participants Analyzed 3 8 11
Mean (Standard Deviation)
Unit of Measure: Millimeters
17.8  (7.0) 16.4  (5.1) 13.8  (5.3)
19.Primary Outcome
Title Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)
Hide Description If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.
Time Frame Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.
Arm/Group Title C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 12 12 16 20 8 13 16 20
Mean (Standard Deviation)
Unit of Measure: Millimeters
20.4  (9.4) 20.7  (8.0) 19.3  (9.8) 22.4  (7.1) 18.1  (6.0) 17.8  (4.8) 17.6  (8.1) 21.1  (7.0)
20.Primary Outcome
Title Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)
Hide Description If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.
Arm/Group Title C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 9 12 16 20 10 12 17 20
Mean (Standard Deviation)
Unit of Measure: Millimeters
18.6  (5.4) 19.0  (6.5) 17.8  (5.7) 20.9  (4.6) 16.8  (4.2) 17.1  (4.3) 16.4  (6.2) 19.1  (4.2)
21.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants who had measurable induration at the time of assessment.
Arm/Group Title B1 - MLSA in Healthy Non-Exposed Participants C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts
Hide Arm/Group Description:
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 2 4 2
Mean (Standard Deviation)
Unit of Measure: Millimeters
5.0  (3.5) 14.0  (3.2) 10.8  (1.1)
22.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Micrograms
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Groups B1 and C1b who had measurable induration at the time of assessment.
Arm/Group Title B1 - MLSA in Healthy Non-Exposed Participants C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts
Hide Arm/Group Description:
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 1 4 3
Mean (Standard Deviation)
Unit of Measure: Millimeters
4.5 11.3  (3.4) 10.3  (0.8)
23.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Group A1 who had measurable induration at the time of assessment.
Arm/Group Title A1 - MLSA in Healthy Non-Exposed Participants
Hide Arm/Group Description:
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Millimeters
25.0
24.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Groups A1, B1 and C1 who had measurable induration at the time of assessment.
Arm/Group Title A1 - MLSA in Healthy Non-Exposed Participants B1 - MLSA in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Overall Number of Participants Analyzed 1 9 1 2 5 7
Mean (Standard Deviation)
Unit of Measure: Millimeters
20.0 9.4  (5.5) 20.0 21.3  (2.5) 14.4  (6.5) 14.1  (4.7)
25.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Groups B1 and C1 who had measurable induration at the time of assessment.
Arm/Group Title B1 - MLSA in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Overall Number of Participants Analyzed 12 1 2 5 7
Mean (Standard Deviation)
Unit of Measure: Millimeters
8.1  (3.4) 16 16.3  (9.5) 17.1  (6.2) 6.4  (2.9)
26.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Groups A2, B2 and C1b who had measurable induration at the time of assessment.
Arm/Group Title C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 5 4 3
Mean (Standard Deviation)
Unit of Measure: Millimeters
14.8  (4) 11.5  (5.1) 8.3  (2.1)
27.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Groups B2 and C1b who had measurable induration at the time of assessment.
Arm/Group Title B2 - MLC in Healthy Non-Exposed Participants C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 1 5 5 1
Mean (Standard Deviation)
Unit of Measure: Millimeters
7.0 11.4  (4.0) 11.8  (3.7) 10.0
28.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Group A2 who had measurable induration at the time of assessment.
Arm/Group Title A2 - MLC in Healthy Non-Exposed Participants
Hide Arm/Group Description:
5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
Overall Number of Participants Analyzed 1
Mean (Standard Deviation)
Unit of Measure: Millimeters
25.0
29.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Groups A2, B2 and C1 who had measurable induration at the time of assessment.
Arm/Group Title A2 - MLC in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Overall Number of Participants Analyzed 1 7 3 9 9
Mean (Standard Deviation)
Unit of Measure: Millimeters
16.5 9.8  (5.1) 20.1  (1.3) 14.2  (4.9) 14.6  (5.4)
30.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Groups B2 and C1 who had measurable induration at the time of assessment.
Arm/Group Title B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Overall Number of Participants Analyzed 10 1 8 7
Mean (Standard Deviation)
Unit of Measure: Millimeters
9.0  (4.7) 23.5 13.8  (7.5) 10.2  (4.9)
31.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Groups A1 and A2 who had measurable induration at the time of assessment.
Arm/Group Title A1 - MLSA in Healthy Non-Exposed Participants A2 - MLC in Healthy Non-Exposed Participants
Hide Arm/Group Description:
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
Overall Number of Participants Analyzed 5 4
Mean (Standard Deviation)
Unit of Measure: Millimeters
19.3  (15.2) 25.5  (11.0)
32.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in all groups who had measurable induration at the time of assessment.
Arm/Group Title A1 - MLSA in Healthy Non-Exposed Participants A2 - MLC in Healthy Non-Exposed Participants B1 - MLSA in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 5 4 30 29 11 11 16 18 11 11 16 18
Mean (Standard Deviation)
Unit of Measure: Millimeters
19.1  (9.7) 20.5  (8.2) 15.1  (5.6) 18.8  (6.5) 18.7  (6.3) 21  (5.4) 17.2  (6.0) 20.1  (4.6) 18.8  (6.3) 21.0  (5.4) 17.2  (6.0) 20.1  (4.6)
33.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in Groups B1, B2, C1 and C1b who had measurable induration at the time of assessment.
Arm/Group Title B1 - MLSA in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 33 31 8 11 15 18 8 11 15 18
Mean (Standard Deviation)
Unit of Measure: Millimeters
14.0  (5.7) 16.0  (5.6) 18.3  (5.8) 18.8  (6.8) 17.0  (5.6) 17.5  (5.6) 18.3  (5.8) 18.8  (6.8) 17.0  (5.6) 17.5  (5.6)
34.Primary Outcome
Title Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)
Hide Description If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
Time Frame Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is restricted to participants in all groups who had measurable induration at the time of assessment.
Arm/Group Title A1 - MLSA in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts C1b - Low Dose MLSA and MLC in Healthy Contacts
Hide Arm/Group Description:
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 1 4 1 1
Mean (Standard Deviation)
Unit of Measure: Millimeters
16.0 13.5  (0) 8.0 8
35.Primary Outcome
Title Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 0.1 Microgram.
Hide Description Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.
Time Frame Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants in Group C1b who received the antigen are included in the analysis population.
Arm/Group Title C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 19 20 20 20
Measure Type: Number
Unit of Measure: Participants
Positive QuantiFERON and Induration > 0 mm 0 5 3 1
Negative QuantiFERON and Induration = 0 mm 2 1 0 1
Negative QuantiFERON and Induration > 0 mm 0 0 0 0
Positive QuantiFERON and Induration = 0 mm 17 12 14 15
Missing QuantiFERON result and/or Induration 0 2 3 3
36.Primary Outcome
Title Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 1.0 Microgram.
Hide Description Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.
Time Frame Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in Group C1 who received the antigen are included in the analysis population.
Arm/Group Title C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
Positive QuantiFERON and Induration > 0 mm 4 5 2 0
Negative QuantiFERON and Induration = 0 mm 5 10 9 12
Negative QuantiFERON and Induration > 0 mm 2 4 0 1
Positive QuantiFERON and Induration = 0 mm 9 1 9 7
Missing QuantiFERON result and/or Induration 0 0 0 0
37.Primary Outcome
Title Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 0.1 Microgram.
Hide Description Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.
Time Frame Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants in Group C1b who received the antigen are included in the analysis population.
Arm/Group Title C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 19 20 20 20
Measure Type: Number
Unit of Measure: Participants
Positive QuantiFERON and Induration > 0 mm 0 6 5 3
Negative QuantiFERON and Induration = 0 mm 3 1 0 1
Negative QuantiFERON and Induration > 0 mm 0 0 0 0
Positive QuantiFERON and Induration = 0 mm 16 11 12 13
Missing QuantiFERON result and/or Induration 0 2 3 3
38.Primary Outcome
Title Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 1.0 Microgram.
Hide Description Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.
Time Frame Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in Group C1 who received the antigen are included in the analysis population.
Arm/Group Title C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
Positive QuantiFERON and Induration > 0 mm 0 2 8 4
Negative QuantiFERON and Induration = 0 mm 9 10 3 7
Negative QuantiFERON and Induration > 0 mm 0 1 2 6
Positive QuantiFERON and Induration = 0 mm 11 7 7 3
Missing QuantiFERON result and/or Induration 0 0 0 0
39.Primary Outcome
Title Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen PPD.
Hide Description Blood collection for the QuantiFERON assessment was at Day 0 prior to antigen administration. Participants are considered to have a positive QuantiFERON response if the result was greater than 0. The categories present the number of participants who are positive or negative by QuantiFERON based on whether or not induration was assessed as present at any of the follow up visit assessments. A fifth category is listed to report the number of participants who were missing either a QuantiFERON result or induration assessment. The categories are mutually exclusive.
Time Frame Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants in Groups C1 and C1b who received the antigen are included in the analysis population.
Arm/Group Title C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 20 20 20 20 19 20 20 20
Measure Type: Number
Unit of Measure: Participants
Positive QuantiFERON and Induration > 0 mm 10 11 15 17 9 13 14 17
Negative QuantiFERON and Induration = 0 mm 4 3 0 1 2 0 0 0
Negative QuantiFERON and Induration > 0 mm 1 1 2 1 0 0 0 0
Positive QuantiFERON and Induration = 0 mm 5 5 3 1 8 5 3 0
Missing QuantiFERON result and/or Induration 0 0 0 0 0 2 3 3
40.Primary Outcome
Title Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 0.1 Microgram
Hide Description Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.
Time Frame Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants in Group C1b who received the antigen are included in the analysis population.
Arm/Group Title C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 19 20 20 20
Measure Type: Number
Unit of Measure: Participants
Pos PGL, Neg QuantiFERON and Induration = 0 mm 1 0 0 0
Neg PGL, Pos QuantiFERON and Induration > 0 mm 0 3 3 0
Pos PGL, Pos QuantiFERON and Induration > 0 mm 0 2 0 1
Neg PGL, Neg QuantiFERON and Induration = 0 mm 1 1 0 1
Neg PGL, Neg QuantiFERON and Induration = 0 mm 0 0 0 0
Pos PGL, Neg QuantiFERON and Induration > 0 mm 0 0 0 0
Neg PGL, Pos QuantiFERON and Induration > 0 mm 4 6 11 13
Pos PGL, Pos QuantiFERON and Induration = 0 mm 13 6 3 2
Missing Either Assay Result or Induration 0 2 3 3
41.Primary Outcome
Title Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLSA-LAM at Doses of 1.0 Microgram
Hide Description Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.
Time Frame Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in Group C1 who received the antigen are included in the analysis population.
Arm/Group Title C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
Pos PGL, Neg QuantiFERON and Induration = 0 mm 3 10 6 12
Neg PGL, Pos QuantiFERON and Induration > 0 mm 2 1 0 0
Pos PGL, Pos QuantiFERON and Induration > 0 mm 2 4 2 0
Neg PGL, Neg QuantiFERON and Induration = 0 mm 2 0 2 0
Neg PGL, Neg QuantiFERON and Induration = 0 mm 0 2 0 0
Pos PGL, Neg QuantiFERON and Induration > 0 mm 2 2 0 1
Neg PGL, Pos QuantiFERON and Induration > 0 mm 4 0 5 0
Pos PGL, Pos QuantiFERON and Induration = 0 mm 5 1 4 7
Missing Either Assay Result or Induration 0 0 1 0
42.Primary Outcome
Title Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 0.1 Microgram
Hide Description Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.
Time Frame Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants in Group C1b who received the antigen are included in the analysis population.
Arm/Group Title C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 19 20 20 20
Measure Type: Number
Unit of Measure: Participants
Pos PGL, Neg QuantiFERON and Induration = 0 mm 2 0 0 0
Neg PGL, Pos QuantiFERON and Induration > 0 mm 0 4 5 2
Pos PGL, Pos QuantiFERON and Induration > 0 mm 0 2 0 1
Neg PGL, Neg QuantiFERON and Induration = 0 mm 1 1 0 1
Neg PGL, Neg QuantiFERON and Induration = 0 mm 0 0 0 0
Pos PGL, Neg QuantiFERON and Induration > 0 mm 0 0 0 0
Neg PGL, Pos QuantiFERON and Induration > 0 mm 4 5 9 11
Pos PGL, Pos QuantiFERON and Induration = 0 mm 12 6 3 2
Missing Either Assay Result or Induration 0 2 3 3
43.Primary Outcome
Title Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen MLCwA at Doses of 1.0 Microgram
Hide Description Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.
Time Frame Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants in Group C1 who received the antigen are included in the analysis population.
Arm/Group Title C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 20 20 20 20
Measure Type: Number
Unit of Measure: Participants
Pos PGL, Neg QuantiFERON and Induration = 0 mm 9 7 1 6
Neg PGL, Pos QuantiFERON and Induration > 0 mm 0 0 5 1
Pos PGL, Pos QuantiFERON and Induration > 0 mm 0 2 3 3
Neg PGL, Neg QuantiFERON and Induration = 0 mm 0 3 2 1
Neg PGL, Neg QuantiFERON and Induration = 0 mm 0 0 0 1
Pos PGL, Neg QuantiFERON and Induration > 0 mm 0 0 2 5
Neg PGL, Pos QuantiFERON and Induration > 0 mm 0 4 1 0
Pos PGL, Pos QuantiFERON and Induration = 0 mm 11 3 6 3
Missing Either Assay Result or Induration 0 1 0 0
44.Primary Outcome
Title Number of Participants Positive for Phenolic Glycolipid-1 (PGL-1) by QuantiFERON Results and the Presence or Absence of Induration at the Injection Site for the Antigen PPD
Hide Description Blood was collected at Day 0 prior to antigen administration for the assessment of PGL-1 and QuantiFERON. The mutually exclusive categories present the number of participants positive or negative by the two assays based on presence of induration at any of the follow up visit assessments. Results for PGL-1 of weakly, moderately or strongly positive are grouped as positive. A result greater than 0 is considered positive for QuantiFERON. A fifth category is listed to report the number of participants who were missing either assay result or the induration assessment.
Time Frame Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All evaluable participants in Group C1 and C1b who received the antigen are included in the analysis population.
Arm/Group Title C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description:
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Number of Participants Analyzed 20 20 20 20 19 20 20 20
Measure Type: Number
Unit of Measure: Participants
Pos PGL, Neg QuantiFERON and Induration = 0 mm 4 0 0 1 1 0 0 0
Neg PGL, Pos QuantiFERON and Induration > 0 mm 0 4 5 3 2 6 12 14
Pos PGL, Pos QuantiFERON and Induration > 0 mm 10 7 10 14 7 7 2 3
Neg PGL, Neg QuantiFERON and Induration = 0 mm 0 2 0 0 1 0 0 0
Neg PGL, Neg QuantiFERON and Induration = 0 mm 0 0 0 0 0 0 0 0
Pos PGL, Neg QuantiFERON and Induration > 0 mm 1 1 2 1 0 0 0 0
Neg PGL, Pos QuantiFERON and Induration > 0 mm 0 1 3 0 2 4 2 0
Pos PGL, Pos QuantiFERON and Induration = 0 mm 5 4 0 1 6 1 1 0
Missing Either Assay Result or Induration 0 1 0 0 0 2 3 3
Time Frame Serious and non-serious adverse events were collected for the duration of the participant's participation in the study, up to 28 days after study product administration.
Adverse Event Reporting Description Solicited reactions were assessed by clinic staff at Days 0, 3, and 7, and at Day 28 if reactions were present at Day 7. Participants are counting as having the reaction if present at any of these days. Events are counted separately for the solicited reactions at each injection site.
 
Arm/Group Title A1 - MLSA in Healthy Non-Exposed Participants A2 - MLC in Healthy Non-Exposed Participants B1 - MLSA in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Hide Arm/Group Description 5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl) 5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl) 45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl) 45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl) 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23 20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23 20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23. 20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23. 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
All-Cause Mortality
A1 - MLSA in Healthy Non-Exposed Participants A2 - MLC in Healthy Non-Exposed Participants B1 - MLSA in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
A1 - MLSA in Healthy Non-Exposed Participants A2 - MLC in Healthy Non-Exposed Participants B1 - MLSA in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   0/5 (0.00%)      0/5 (0.00%)      2/45 (4.44%)      0/45 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Infections and infestations                         
Appendicitis * 1  0/5 (0.00%)  0 0/5 (0.00%)  0 1/45 (2.22%)  1 0/45 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
Nervous system disorders                         
Cerebral haemorrhage * 1  0/5 (0.00%)  0 0/5 (0.00%)  0 1/45 (2.22%)  1 0/45 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (7.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A1 - MLSA in Healthy Non-Exposed Participants A2 - MLC in Healthy Non-Exposed Participants B1 - MLSA in Healthy Non-Exposed Participants B2 - MLC in Healthy Non-Exposed Participants C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts CI - High Dose MLSA and MLC in TB Patients C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients C1b - Low Dose MLSA and MLC in Healthy Contacts C1b - Low Dose MLSA and MLC in TB Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events 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   5/5 (100.00%)      4/5 (80.00%)      36/45 (80.00%)      35/45 (77.78%)      13/20 (65.00%)      15/20 (75.00%)      19/20 (95.00%)      20/20 (100.00%)      11/20 (55.00%)      16/20 (80.00%)      18/20 (90.00%)      20/20 (100.00%)    
General disorders                         
Induration  1  5/5 (100.00%)  6 4/5 (80.00%)  5 34/45 (75.56%)  46 31/45 (68.89%)  42 12/20 (60.00%)  12 14/20 (70.00%)  16 18/20 (90.00%)  30 18/20 (90.00%)  34 9/20 (45.00%)  11 15/20 (75.00%)  20 17/20 (85.00%)  22 20/20 (100.00%)  21
Pain  1  1/5 (20.00%)  1 2/5 (40.00%)  2 14/45 (31.11%)  16 13/45 (28.89%)  13 7/20 (35.00%)  8 8/20 (40.00%)  8 5/20 (25.00%)  7 9/20 (45.00%)  11 3/20 (15.00%)  3 1/20 (5.00%)  1 4/20 (20.00%)  4 3/20 (15.00%)  3
Immune system disorders                         
Type IV hypersensitivity reaction * 2  0/5 (0.00%)  0 0/5 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Infections and infestations                         
Infection  1  0/5 (0.00%)  0 0/5 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders                         
Erythema  1  5/5 (100.00%)  9 4/5 (80.00%)  7 36/45 (80.00%)  46 34/45 (75.56%)  45 13/20 (65.00%)  16 15/20 (75.00%)  22 19/20 (95.00%)  36 20/20 (100.00%)  46 11/20 (55.00%)  11 16/20 (80.00%)  27 18/20 (90.00%)  26 20/20 (100.00%)  27
Pruritis  1  0/5 (0.00%)  0 0/5 (0.00%)  0 17/45 (37.78%)  17 17/45 (37.78%)  18 5/20 (25.00%)  5 6/20 (30.00%)  6 10/20 (50.00%)  25 15/20 (75.00%)  21 0/20 (0.00%)  0 9/20 (45.00%)  11 6/20 (30.00%)  7 12/20 (60.00%)  12
Urticaria  1  1/5 (20.00%)  1 2/5 (40.00%)  2 0/45 (0.00%)  0 1/45 (2.22%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Blister  1  1/5 (20.00%)  1 0/5 (0.00%)  0 0/45 (0.00%)  0 4/45 (8.89%)  4 2/20 (10.00%)  2 0/20 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2 0/20 (0.00%)  0
Vascular disorders                         
Haemorrhage  1  0/5 (0.00%)  0 0/5 (0.00%)  0 0/45 (0.00%)  0 0/45 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
2
Term from vocabulary, MedDRA 12.1
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
Name/Title: Patrick J. Brennan, Ph.D.
Organization: Colorado State University, Department of Microbiology, Immunology and Pathology
Phone: 970-491-6700
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00128193     History of Changes
Other Study ID Numbers: 00-002
First Submitted: August 5, 2005
First Posted: August 9, 2005
Results First Submitted: September 30, 2010
Results First Posted: November 1, 2010
Last Update Posted: December 24, 2014