Trial Outcomes & Findings for Leprosy Skin Test Antigens Trial (NCT NCT00128193)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

260 participants

Primary outcome timeframe

Up to 28 Days

Results posted on

2014-12-24

Participant Flow

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.

Participant milestones

Participant milestones
Measure	A1 - MLSA in Healthy Non-Exposed Participants 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)	A2 - MLC in Healthy Non-Exposed Participants 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)	B1 - MLSA in Healthy Non-Exposed Participants 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)	B2 - MLC in Healthy Non-Exposed Participants 45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients 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	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Overall Study STARTED	5	5	45	45	20	20	20	20	20	20	20	20
Overall Study COMPLETED	5	5	42	44	18	17	16	20	18	18	17	18
Overall Study NOT COMPLETED	0	0	3	1	2	3	4	0	2	2	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Leprosy Skin Test Antigens Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A1 - MLSA in Healthy Non-Exposed Participants n=5 Participants 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)	A2 - MLC in Healthy Non-Exposed Participants n=5 Participants 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)	B1 - MLSA in Healthy Non-Exposed Participants n=45 Participants 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)	B2 - MLC in Healthy Non-Exposed Participants n=45 Participants 45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=20 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts n=20 Participants 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.	C1b - Low Dose MLSA and MLC in TB Patients n=20 Participants 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.	Total n=260 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	13 Participants n=5 Participants	10 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	1 Participants n=42 Participants	33 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	32 Participants n=5 Participants	35 Participants n=4 Participants	20 Participants n=21 Participants	20 Participants n=8 Participants	20 Participants n=8 Participants	16 Participants n=24 Participants	20 Participants n=42 Participants	19 Participants n=42 Participants	16 Participants n=42 Participants	19 Participants n=42 Participants	227 Participants n=36 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Age, Continuous	30.6 years STANDARD_DEVIATION 6.4 • n=5 Participants	29.4 years STANDARD_DEVIATION 2.9 • n=7 Participants	21.1 years STANDARD_DEVIATION 5.3 • n=5 Participants	23.1 years STANDARD_DEVIATION 6.7 • n=4 Participants	37.5 years STANDARD_DEVIATION 12.3 • n=21 Participants	32.9 years STANDARD_DEVIATION 12.9 • n=8 Participants	32.9 years STANDARD_DEVIATION 11.0 • n=8 Participants	26.0 years STANDARD_DEVIATION 7.7 • n=24 Participants	35.2 years STANDARD_DEVIATION 13.1 • n=42 Participants	39.0 years STANDARD_DEVIATION 13.5 • n=42 Participants	30.2 years STANDARD_DEVIATION 12.1 • n=42 Participants	31.1 years STANDARD_DEVIATION 13.1 • n=42 Participants	28.5 years STANDARD_DEVIATION 11.3 • n=36 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants	8 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	7 Participants n=8 Participants	7 Participants n=24 Participants	5 Participants n=42 Participants	4 Participants n=42 Participants	14 Participants n=42 Participants	5 Participants n=42 Participants	84 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	31 Participants n=5 Participants	37 Participants n=4 Participants	14 Participants n=21 Participants	14 Participants n=8 Participants	13 Participants n=8 Participants	13 Participants n=24 Participants	15 Participants n=42 Participants	16 Participants n=42 Participants	6 Participants n=42 Participants	15 Participants n=42 Participants	176 Participants n=36 Participants
Region of Enrollment Nepal	5 participants n=5 Participants	5 participants n=7 Participants	45 participants n=5 Participants	45 participants n=4 Participants	20 participants n=21 Participants	20 participants n=8 Participants	20 participants n=8 Participants	20 participants n=24 Participants	20 participants n=42 Participants	20 participants n=42 Participants	20 participants n=42 Participants	20 participants n=42 Participants	260 participants n=36 Participants

PRIMARY outcome

Timeframe: Up to 28 Days

Population: All participants who received the antigen are included in the analysis population.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	B1 - MLSA in Healthy Non-Exposed Participants n=45 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=20 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=5 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram Erythema	4 Participants	3 Participants	1 Participants	5 Participants	2 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram Pain/Tenderness	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram Bleeding	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram Urticaria	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram Infection	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram Induration	2 Participants	2 Participants	0 Participants	4 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram Blistering/Ulcerating	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 28 Days

Population: All participants in Groups B and C who received the antigen are included in the analysis population.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	B1 - MLSA in Healthy Non-Exposed Participants n=20 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=45 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
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	0 Participants	0 Participants	1 Participants	1 Participants	—	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 28 Days

Population: All participants who received the antigen are included in the analysis population.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	B1 - MLSA in Healthy Non-Exposed Participants n=45 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=20 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=5 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram Erythema	11 Participants	10 Participants	2 Participants	4 Participants	12 Participants	4 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram Induration	5 Participants	12 Participants	1 Participants	2 Participants	7 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram Pain/Tenderness	1 Participants	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram Urticaria	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram Infection	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram Blistering/Ulcerating	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram Bleeding	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 28 Days

Population: All participants in Groups B and C who received the antigen are included in the analysis population.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	B1 - MLSA in Healthy Non-Exposed Participants n=20 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=45 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
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	1 Participants	0 Participants	0 Participants	4 Participants	—	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 28 Days

Population: All participants who received the antigen are included in the analysis population.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	B1 - MLSA in Healthy Non-Exposed Participants n=45 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=20 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=5 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram Erythema	5 Participants	1 Participants	1 Participants	8 Participants	5 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram Bleeding	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram Urticaria	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram Blistering/Ulcerating	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram Infection	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram Induration	5 Participants	1 Participants	0 Participants	5 Participants	3 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram Pain/Tenderness	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 28 Days

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	B1 - MLSA in Healthy Non-Exposed Participants n=20 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=45 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Number of Participants With Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram	0 Participants	0 Participants	2 Participants	1 Participants	—	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 28 Days

Population: All participants who received the antigen are included in the analysis population.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	B1 - MLSA in Healthy Non-Exposed Participants n=45 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=20 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=5 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram Induration	9 Participants	10 Participants	0 Participants	3 Participants	9 Participants	1 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram Bleeding	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram Urticaria	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram Erythema	8 Participants	11 Participants	2 Participants	5 Participants	14 Participants	3 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram Pain/Tenderness	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram Infection	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram Blistering/Ulcerating	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 28 Days

Population: All participants in Groups B and C who received the antigen are included in the analysis population.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	B1 - MLSA in Healthy Non-Exposed Participants n=20 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=45 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Number of Participants With the Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram	6 Participants	0 Participants	1 Participants	5 Participants	—	1 Participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to 28 Days

Population: All participants who received the antigen are included in the analysis population.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	B1 - MLSA in Healthy Non-Exposed Participants n=5 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=45 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=45 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=20 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=5 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=20 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts n=20 Participants 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.	C1b - Low Dose MLSA and MLC in TB Patients n=20 Participants 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD) Infection	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD) Erythema	12 Participants	4 Participants	33 Participants	33 Participants	13 Participants	5 Participants	17 Participants	20 Participants	9 Participants	14 Participants	17 Participants	20 Participants
Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD) Induration	11 Participants	4 Participants	33 Participants	31 Participants	11 Participants	5 Participants	16 Participants	18 Participants	11 Participants	11 Participants	16 Participants	18 Participants
Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD) Pain/Tenderness	6 Participants	2 Participants	12 Participants	13 Participants	7 Participants	1 Participants	5 Participants	9 Participants	3 Participants	1 Participants	3 Participants	3 Participants
Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD) Bleeding	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD) Urticaria	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD) Blistering/Ulcerating	2 Participants	0 Participants	0 Participants	4 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 28 Days

Population: All participants in Groups B and C who received the antigen are included in the analysis population.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	B1 - MLSA in Healthy Non-Exposed Participants n=45 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=20 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=45 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=20 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients n=20 Participants 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Number of Participants With the Reaction of Itching to the Antigen Purified Protein Derivative (PPD)	9 Participants	17 Participants	5 Participants	5 Participants	14 Participants	17 Participants	0 Participants	8 Participants	5 Participants	12 Participants	—	—

PRIMARY outcome

Timeframe: Day 3

Population: The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients 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	B1 - MLSA in Healthy Non-Exposed Participants n=4 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=2 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=5 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
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	—	9.8 Millimeters Standard Deviation 1.8	9.3 Millimeters Standard Deviation 0.6	—	—	12.6 Millimeters Standard Deviation 4.2	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 7

Population: The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients 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	B1 - MLSA in Healthy Non-Exposed Participants n=3 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=3 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=4 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
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	—	10.3 Millimeters Standard Deviation 0.8	9.8 Millimeters Standard Deviation 2.4	—	—	11.3 Millimeters Standard Deviation 3.4	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 3

Population: The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients 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	B1 - MLSA in Healthy Non-Exposed Participants n=2 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=7 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=8 Participants 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=1 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
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	—	23.3 Millimeters Standard Deviation 4.6	13.0 Millimeters Standard Deviation 5.9	14.8 Millimeters Standard Deviation 6.5	—	20.0 Millimeters	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 7

Population: The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients 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	B1 - MLSA in Healthy Non-Exposed Participants n=2 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=9 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=10 Participants 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=1 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
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	—	20.3 Millimeters Standard Deviation 5.3	13.8 Millimeters Standard Deviation 6.6	14.3 Millimeters Standard Deviation 6.6	—	16.0 Millimeters	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 3

Population: The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients 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	B1 - MLSA in Healthy Non-Exposed Participants n=6 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=5 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=7 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms	—	13.0 Millimeters Standard Deviation 4.6	9.6 Millimeters Standard Deviation 2.3	—	—	15.1 Millimeters Standard Deviation 3.3	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 7

Population: The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients 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	B1 - MLSA in Healthy Non-Exposed Participants n=6 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=4 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=5 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms	—	12.2 Millimeters Standard Deviation 3.4	8.9 Millimeters Standard Deviation 1.4	—	—	12.1 Millimeters Standard Deviation 5.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 3

Population: The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients 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	B1 - MLSA in Healthy Non-Exposed Participants n=3 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=9 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=11 Participants 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=1 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms	—	20.8 Millimeters Standard Deviation 2.9	14.7 Millimeters Standard Deviation 5.7	15.0 Millimeters Standard Deviation 6.1	—	9.0 Millimeters	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 7

Population: The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients 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	B1 - MLSA in Healthy Non-Exposed Participants n=8 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=11 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=3 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts 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	CI - High Dose MLSA and MLC in TB Patients 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms	—	16.4 Millimeters Standard Deviation 5.1	13.8 Millimeters Standard Deviation 5.3	—	—	17.8 Millimeters Standard Deviation 7.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 3

Population: The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=8 Participants 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	B1 - MLSA in Healthy Non-Exposed Participants n=12 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=16 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=13 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=12 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts n=16 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=20 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)	18.1 Millimeters Standard Deviation 6.0	20.7 Millimeters Standard Deviation 8.0	19.3 Millimeters Standard Deviation 9.8	22.4 Millimeters Standard Deviation 7.1	17.8 Millimeters Standard Deviation 4.8	20.4 Millimeters Standard Deviation 9.4	17.6 Millimeters Standard Deviation 8.1	21.1 Millimeters Standard Deviation 7.0	—	—	—	—

PRIMARY outcome

Timeframe: Day 7

Population: The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.

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.

Outcome measures

Outcome measures
Measure	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=10 Participants 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	B1 - MLSA in Healthy Non-Exposed Participants n=12 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients n=16 Participants 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	C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients n=20 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=12 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	B1 - MLSA in Healthy Non-Exposed Participants n=9 Participants 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)	C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts n=17 Participants 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	CI - High Dose MLSA and MLC in TB Patients n=20 Participants 20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23	C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients 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	C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients 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.	C1b - Low Dose MLSA and MLC in Healthy Contacts 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.	C1b - Low Dose MLSA and MLC in TB Patients 20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)	16.8 Millimeters Standard Deviation 4.2	19.0 Millimeters Standard Deviation 6.5	17.8 Millimeters Standard Deviation 5.7	20.9 Millimeters Standard Deviation 4.6	17.1 Millimeters Standard Deviation 4.3	18.6 Millimeters Standard Deviation 5.4	16.4 Millimeters Standard Deviation 6.2	19.1 Millimeters Standard Deviation 4.2	—	—	—	—

PRIMARY outcome

Timeframe: Day 3

Population: The analysis population is restricted to participants who had measurable induration at the time of assessment.