Leprosy Skin Test Antigens Trial

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00128193

Collaborator

(none)

260

Enrollment

Locations

Arms

Duration (Months)

43.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see how healthy people and leprosy patients react to 2 new skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in measuring the number of people exposed to leprosy and enable its diagnosis and treatment at an earlier stage. Participant's ages 18-60 living in Kathmandu, Nepal will be enrolled. Stages A and B of the study will use the skin test in healthy volunteers. Stage C will use the skin test in high risk volunteers (including individuals with leprosy), healthy individuals in contact with leprosy patients and individuals with tuberculosis (TB, lung disease). Study procedures will include injections, physical exam, and blood testing. Injection sites will be checked several times during the participant's study involvement (5 hours of time spread over approximately 1 month). Volunteers screened for the study, which have leprosy or tuberculosis will be treated or referred for treatment.

Condition or Disease	Intervention/Treatment	Phase
Leprosy	Biological: Tuberculin, Purified Protein Derivative Other: MLSA-LAM Other: MLCwA Biological: Tuberculin, Purified Protein Derivative Other: Placebo	Phase 2

Detailed Description

This double-blind Phase II clinical trial will be conducted in 3 stages to evaluate 2 new leprosy skin test antigens, Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) and M. leprae Cell Wall Antigen (MLCwA), as diagnostic-epidemiological tools designed to measure incidence of leprosy infection in Kathmandu, Nepal, a leprosy endemic area. Stage A will provide an initial indication of safety of the 2 new test antigens in 10 healthy members of the leprosy endemic population (5 subjects per antigen at 2 dosages each). Stage B will expand this analysis by an additional 90 healthy subjects (45 subjects per antigen). If any subjects in Stage A or B show ulcerations at the 1.0 mcg dose of MLSA-LAM or MLCwA test sites, then only the 0.1 mcg dose will be used for Stage C. The final stage, Stage C, is divided into 2 parts. The first part, Stage C-1, will assess safety of both antigens at the high dose (1.0 mcg) in populations at a higher risk of developing ulcerations at skin test sites. Eighty subjects will be recruited: 20 household contacts of Borderline Lepromatous Leprosy (BL) / Lepromatous Leprosy (LL) leprosy patients, 20 BL/LL leprosy patients, 20 Borderline Tuberculoid Leprosy (BT) / Tuberculoid Leprosy (TT) patients and 20 tuberculosis (TB) patients. The second part, Stage C-1b, is a continuation of Stage C-1 with the same number of subjects recruited from the same groups to assess the reactivity of both antigens at the low dose (0.1 mcg). This study will define a positive skin test reaction for MLSA-LAM and MLCwA, and this definition will be used in estimating sensitivity and specificity for each skin test antigen and dosage. It is expected that the BT/TT leprosy patients and healthy contacts of leprosy patients will have larger indurations at both M. leprae-derived antigen sites and a variable reaction at the tuberculin/Purified Protein Derivative (PPD) site. The non-contacts, BL/LL leprosy patients, and TB patients will have smaller indurations at all leprosy skin test sites and a variable reaction at the tuberculin/PPD site. Finally, the TB patients will react with a large induration at the tuberculin/PPD site. Primary study objectives are to evaluate safety of these 2 new leprosy skin test antigens and to estimate specificity and sensitivity of these skin test antigens in detecting M. leprae infection by: selecting a dosage of the MLSA-LAM and MLCwA antigens that causes minimal induration in healthy non-exposed subjects; selecting a size of induration that will serve as a definition of a positive skin test reaction for MLSA-LAM and MLCwA in leprosy patients; and comparing proportion of positive skin test reactors in healthy subjects to proportion in BT/TT and BL/LL leprosy patients, contacts of leprosy patients, and TB patients. Secondary study objectives are to compare mean size of induration in response to each test antigen in healthy subjects versus BT/TT and BL/LL leprosy patients, contacts of leprosy patients, and TB patients as a measure of specificity and sensitivity; to compare the specificity and sensitivity of the 2 new antigens with tuberculin/PPD in patients with clinical leprosy, contacts of leprosy patients, and healthy unexposed subjects (non-patient contacts); to quantify release of IFN-gamma from lymphocytes in whole blood from leprosy patients, leprosy patient contacts, TB patients, and healthy nonexposed subjects, following in vitro stimulation with leprosy skin test antigens and PPD, using the QuantiFERON-CMI (Cellestis Limited, Valentia California) kit. Results will be compared to the magnitude of the skin test response; and to determine if antibodies against a

leprae specific anti

Study Design

Study Type:

Interventional

Actual Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

Official Title:

Two New Leprosy Skin Test Antigens: MLSA-LAM and MLCwA Phase II Study in a Leprosy-Endemic Region

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A1-Ramping (MLSA-LAM) 5 subjects to receive: 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl).	Other: MLSA-LAM Mycobacterium leprae soluble antigen with minimal amounts of immunosuppressive lipoglycans; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl). Biological: Tuberculin, Purified Protein Derivative Licensed TB reagent, 100 microliters, 5 TU dose. Other: Placebo Saline (NaCl) serves as a diluent control in Stage A and B only.
Experimental: C1-Target Population 80 subjects to receive: 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.	Biological: Tuberculin, Purified Protein Derivative A tuberculin skin test used to diagnose latent tuberculosis (TB) infection. 2 TU dose Other: MLSA-LAM Mycobacterium leprae soluble antigen with minimal amounts of immunosuppressive lipoglycans; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl). Other: MLCwA Cell wall-associated proteins of Mycobacterium leprae; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl).
Experimental: C-1b-Target Population (Low Dose) 80 subjects to receive: 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.	Biological: Tuberculin, Purified Protein Derivative A tuberculin skin test used to diagnose latent tuberculosis (TB) infection. 2 TU dose Other: MLSA-LAM Mycobacterium leprae soluble antigen with minimal amounts of immunosuppressive lipoglycans; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl). Other: MLCwA Cell wall-associated proteins of Mycobacterium leprae; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl).
Experimental: B2-Full-Scale (MLCwA) 45 subjects to receive: 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl).	Other: MLCwA Cell wall-associated proteins of Mycobacterium leprae; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl). Biological: Tuberculin, Purified Protein Derivative Licensed TB reagent, 100 microliters, 5 TU dose. Other: Placebo Saline (NaCl) serves as a diluent control in Stage A and B only.
Experimental: B1-Full-Scale (MLSA-LAM) 45 subjects to receive: 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl).	Other: MLSA-LAM Mycobacterium leprae soluble antigen with minimal amounts of immunosuppressive lipoglycans; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl). Biological: Tuberculin, Purified Protein Derivative Licensed TB reagent, 100 microliters, 5 TU dose. Other: Placebo Saline (NaCl) serves as a diluent control in Stage A and B only.
Experimental: A2-Ramping (MLCwA) 5 subjects to receive: 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl).	Other: MLCwA Cell wall-associated proteins of Mycobacterium leprae; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl). Biological: Tuberculin, Purified Protein Derivative Licensed TB reagent, 100 microliters, 5 TU dose. Other: Placebo Saline (NaCl) serves as a diluent control in Stage A and B only.

Outcome Measures

Primary Outcome Measures

Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram [Up to 28 Days]
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.
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 [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.
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram [Up to 28 Days]
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.
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 [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.
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram [Up to 28 Days]
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.
Number of Participants With Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram [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.
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram [Up to 28 Days]
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.
Number of Participants With the Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram [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.
Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD) [Up to 28 Days]
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.
Number of Participants With the Reaction of Itching to the Antigen Purified Protein Derivative (PPD) [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.
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 [Day 3]
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.
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 [Day 7]
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.
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 [Day 3]
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.
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 [Day 7]
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.
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms [Day 3]
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.
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms [Day 7]
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.
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms [Day 3]
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.
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms [Day 7]
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.
Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD) [Day 3]
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.
Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD) [Day 7]
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.
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 [Day 3]
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).
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 [Day 7]
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).
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 [Day 2]
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).
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 [Day 3]
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).
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 [Day 7]
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).
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms [Day 3]
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).
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms [Day 7]
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).
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms [Day 2]
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).
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms [Day 3]
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).
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms [Day 7]
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).
Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD) [Day 2]
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).
Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD) [Day 3]
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).
Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD) [Day 7]
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).
Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD) [Day 28]
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).
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. [Day 0 for QuantiFERON; Days 3, 7, and 28 for induration]
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.
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. [Day 0 for QuantiFERON; Days 3, 7, and 28 for induration]
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.
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. [Day 0 for QuantiFERON; Days 3, 7, and 28 for induration]
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.
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. [Day 0 for QuantiFERON; Days 3, 7, and 28 for induration]
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.
Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen PPD. [Day 0 for QuantiFERON; Days 3, 7, and 28 for induration]
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.
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 [Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration]
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.
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 [Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration]
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.
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 [Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration]
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.
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 [Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration]
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.
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 [Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All Subjects

Between the ages of 18 and 60 years old
Male or female; not less than 30 percent for one gender
Agree to participate in the study after verbal explanation by the physician and nurses, as indicated by signing an informed consent form
Weight greater than 30 Kg (female) and 38 Kg (male)
Available for skin test readings
Nepali residents, including expatriates from India

Healthy, Non-Contacts

Healthy (determined by history and physical examination)
No household or working contact with tuberculosis or leprosy patients

Contacts of Leprosy Patients

Healthy (determined by history and physical examination)
Household contact of a person with leprosy for at least 6 months duration, and within 6 months of this study, or a person professionally exposed to leprosy for at least 5 years duration, and within 6 months of this study

Persons with Leprosy

Having one or more of the following symptoms:

Hypopigmented or erythematous skin lesion(s) with definite loss of sensation
Damage to the peripheral nerves as demonstrated by palpable thickening with or without impairment of sensation and/or weakness of the muscles of hands, feet or face
Presence of acid-fast bacilli in slit skin smears
Histological changes diagnostic of leprosy in skin biopsy

Receiving standard multi drug treatment for leprosy or completed treatment for leprosy no more than 4 years prior to study enrollment

Persons with Tuberculosis

Having active tuberculosis as defined by one of the following:

Extra-pulmonary tuberculosis if confirmed by culture
Pulmonary tuberculosis, defined as:

Having a history of a productive cough of more than 3 weeks duration that may be accompanied by night sweats, loss of appetite, haemoptysis, weight loss, chest pain, or shortness of breath, and
Having one or more of the following diagnostic criteria:
Sputum smear-positive, defined as one or more of the following: at least 2 of 3 successive sputum samples positive for acid-fast bacilli by microscopy; or at least one sputum specimen positive and x-ray abnormalities consistent with pulmonary tuberculosis; or at least one positive sputum specimen that is culture positive for Mycobacterium tuberculosis
Sputum smear-negative, defined as three sputum specimens negative for acid-fast bacilli but with x-ray evidence consistent with pulmonary tuberculosis and that does not clear with non-tuberculosis antibiotics; or three sputum samples negative for acid-fast bacilli by microscopy but culture positive for Mycobacterium tuberculosis
Completed the intensive phase of chemotherapy for tuberculosis, but still undergoing the continuation phase of therapy

Exclusion Criteria:

All subjects

Pregnant (as determined by a urine pregnancy test performed on females of child-bearing age on Day 0, prior to admission into the study) or lactating females
Currently on oral corticosteroid or other immunosuppressive treatment
Cancer, diabetes, or other chronic illness
Extra-pulmonary tuberculosis not confirmed by culture
Known hypersensitivities or allergies
Expatriates other than those from India
Participation in an earlier stage of this study
Concurrent participation in another clinical trial

Healthy, Non-Contacts

History of treated tuberculosis or leprosy
Clinical signs of leprosy or tuberculosis
Known contact with persons with leprosy or tuberculosis

Healthy Contacts of Leprosy Patients

History of treated tuberculosis or leprosy
Clinical signs of leprosy or tuberculosis

Persons with Leprosy

Leprosy patients in reversal reaction or erythema nodosum leprosum (ENL) reaction or those being treated with corticosteroids or thalidomide for these conditions
History of treated tuberculosis
Clinical signs of tuberculosis
Completed full course of standard multidrug treatment (MDT) for leprosy more than 4 years prior to study enrollment

Persons with Tuberculosis

History of treated leprosy
Clinical signs of leprosy
Completed full course of standard tuberculosis treatment
Known contact with leprosy patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Colorado State University - Microbiology, Immunology & Pathology	Fort Collins	Colorado	United States	80523
2	Anandaban Hospital	Kathmandu		Nepal
3	Green Pastures Hospitals	Kathmandu		Nepal
4	Lalitpur Nursing Campus	Kathmandu		Nepal
5	Patan Hospital	Kathmandu		Nepal
6	Tribhuvan University - Anandaban Hospital	Kathmandu		Nepal

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00128193

Other Study ID Numbers:

00-002

First Posted:

Aug 9, 2005

Last Update Posted:

Dec 24, 2014

Last Verified:

Aug 1, 2010

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)

leprosy, Mycobacterium leprae, Hansen's Disease, skin test, Nepal

Additional relevant MeSH terms:

Leprosy

Study Results

Participant Flow

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 Detail

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
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

Baseline Characteristics

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
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 Participants	5	5	45	45	20	20	20	20	20	20	20	20	260
Age (Count of Participants)
<=18 years	0 0%	0 0%	13 28.9%	10 22.2%	0 0%	0 0%	0 0%	4 20%	0 0%	1 5%	4 20%	1 5%	33 12.7%
Between 18 and 65 years	5 100%	5 100%	32 71.1%	35 77.8%	20 100%	20 100%	20 100%	16 80%	20 100%	19 95%	16 80%	19 95%	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%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	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 (Count of Participants)
Female	4 80%	4 80%	14 31.1%	8 17.8%	6 30%	6 30%	7 35%	7 35%	5 25%	4 20%	14 70%	5 25%	84 32.3%
Male	1 20%	1 20%	31 68.9%	37 82.2%	14 70%	14 70%	13 65%	13 65%	15 75%	16 80%	6 30%	15 75%	176 67.7%
Region of Enrollment (participants) [Number]
Nepal	5 100%	5 100%	45 100%	45 100%	20 100%	20 100%	20 100%	20 100%	20 100%	20 100%	20 100%	20 100%	260 100%

Outcome Measures

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
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

Outcome Measure Data

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
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.
Measure Participants	5	45	20	20	20	20
Erythema	0 0%	3 60%	1 2.2%	5 11.1%	4 20%	2 10%
Induration	0 0%	2 40%	0 0%	4 8.9%	2 10%	0 0%
Pain/Tenderness	0 0%	1 20%	0 0%	0 0%	1 5%	0 0%
Bleeding	0 0%	0 0%	0 0%	0 0%	1 5%	0 0%
Urticaria	0 0%	0 0%	0 0%	0 0%	1 5%	0 0%
Infection	0 0%	0 0%	0 0%	0 0%	1 5%	0 0%
Blistering/Ulcerating	0 0%	0 0%	0 0%	0 0%	1 5%	0 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
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

Outcome Measure Data

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
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.
Measure Participants	45	20	20	20	20
Number [Participants]	0 0%	0 0%	1 2.2%	1 2.2%	0 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
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

Outcome Measure Data

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
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
Measure Participants	5	45	20	20	20	20
Erythema	4 80%	10 200%	2 4.4%	4 8.9%	11 55%	12 60%
Induration	1 20%	12 240%	1 2.2%	2 4.4%	5 25%	7 35%
Pain/Tenderness	0 0%	3 60%	1 2.2%	0 0%	1 5%	0 0%
Bleeding	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urticaria	0 0%	0 0%	0 0%	0 0%	0 0%	1 5%
Infection	0 0%	0 0%	0 0%	0 0%	0 0%	1 5%
Blistering/Ulcerating	0 0%	0 0%	0 0%	0 0%	0 0%	1 5%

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
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

Outcome Measure Data

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
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
Measure Participants	45	20	20	20	20
Number [Participants]	0 0%	0 0%	0 0%	4 8.9%	1 5%

5. Primary Outcome

Title	Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram
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

Outcome Measure Data

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
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.
Measure Participants	5	45	20	20	20	20
Erythema	0 0%	1 20%	1 2.2%	8 17.8%	5 25%	5 25%
Induration	0 0%	1 20%	0 0%	5 11.1%	5 25%	3 15%
Pain/Tenderness	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Bleeding	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urticaria	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Infection	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Blistering/Ulcerating	0 0%	0 0%	0 0%	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
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

Outcome Measure Data

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
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.
Measure Participants	45	20	20	20	20
Number [Participants]	0 0%	0 0%	2 4.4%	1 2.2%	0 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
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

Outcome Measure Data

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
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
Measure Participants	5	45	20	20	20	20
Erythema	3 60%	11 220%	2 4.4%	5 11.1%	8 40%	14 70%
Induration	1 20%	10 200%	0 0%	3 6.7%	9 45%	9 45%
Pain/Tenderness	0 0%	0 0%	1 2.2%	1 2.2%	1 5%	2 10%
Bleeding	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urticaria	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Infection	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Blistering/Ulcerating	0 0%	0 0%	0 0%	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
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

Outcome Measure Data

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
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
Measure Participants	45	20	20	20	20
Number [Participants]	1 20%	0 0%	1 2.2%	5 11.1%	6 30%

9. Primary Outcome

Title	Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD)
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

Outcome Measure Data

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
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.
Measure Participants	5	5	45	45	20	20	20	20	20	20	20	20
Erythema	5 100%	4 80%	33 73.3%	33 73.3%	12 60%	13 65%	17 85%	20 100%	9 45%	14 70%	17 85%	20 100%
Induration	5 100%	4 80%	33 73.3%	31 68.9%	11 55%	11 55%	16 80%	18 90%	11 55%	11 55%	16 80%	18 90%
Pain/Tenderness	1 20%	2 40%	12 26.7%	13 28.9%	6 30%	7 35%	5 25%	9 45%	3 15%	1 5%	3 15%	3 15%
Bleeding	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Urticaria	1 20%	2 40%	0 0%	1 2.2%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Infection	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Blistering/Ulcerating	1 20%	0 0%	0 0%	4 8.9%	2 10%	0 0%	1 5%	0 0%	0 0%	0 0%	1 5%	0 0%

10. Primary Outcome

Title	Number of Participants With the Reaction of Itching to the Antigen Purified Protein Derivative (PPD)
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

Outcome Measure Data

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
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.
Measure Participants	45	45	20	20	20	20	20	20	20	20
Number [Participants]	17 340%	17 340%	5 11.1%	5 11.1%	9 45%	14 70%	0 0%	8 40%	5 25%	12 60%

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
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

Outcome Measure Data

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
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.
Measure Participants	5	4	2
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	4	3	3
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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
Measure Participants	1	2	7	8
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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
Measure Participants	1	2	9	10
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	7	6	5
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	5	6	4
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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
Measure Participants	1	3	9	11
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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
Measure Participants	3	8	11
Mean (Standard Deviation) [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)
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

Outcome Measure Data

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
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.
Measure Participants	12	12	16	20	8	13	16	20
Mean (Standard Deviation) [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)
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

Outcome Measure Data

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
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.
Measure Participants	9	12	16	20	10	12	17	20
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	2	4	2
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	1	4	3
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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)
Measure Participants	1
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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
Measure Participants	1	9	1	2	5	7
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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
Measure Participants	12	1	2	5	7
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	5	4	3
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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.
Measure Participants	1	5	5	1
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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)
Measure Participants	1
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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
Measure Participants	1	7	3	9	9
Mean (Standard Deviation) [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
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

Outcome Measure Data

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
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
Measure Participants	10	1	8	7
Mean (Standard Deviation) [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)
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

Outcome Measure Data

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
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)
Measure Participants	5	4
Mean (Standard Deviation) [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)
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

Outcome Measure Data

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
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.
Measure Participants	5	4	30	29	11	11	16	18	11	11	16	18
Mean (Standard Deviation) [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)
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

Outcome Measure Data

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
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.
Measure Participants	33	31	8	11	15	18	8	11	15	18
Mean (Standard Deviation) [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)
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

Outcome Measure Data

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
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.
Measure Participants	1	4	1	1
Mean (Standard Deviation) [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.
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

Outcome Measure Data

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
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.
Measure Participants	19	20	20	20
Positive QuantiFERON and Induration > 0 mm	0 0%	5 100%	3 6.7%	1 2.2%
Negative QuantiFERON and Induration = 0 mm	2 40%	1 20%	0 0%	1 2.2%
Negative QuantiFERON and Induration > 0 mm	0 0%	0 0%	0 0%	0 0%
Positive QuantiFERON and Induration = 0 mm	17 340%	12 240%	14 31.1%	15 33.3%
Missing QuantiFERON result and/or Induration	0 0%	2 40%	3 6.7%	3 6.7%

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.
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

Outcome Measure Data

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
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.
Measure Participants	20	20	20	20
Positive QuantiFERON and Induration > 0 mm	4 80%	5 100%	2 4.4%	0 0%
Negative QuantiFERON and Induration = 0 mm	5 100%	10 200%	9 20%	12 26.7%
Negative QuantiFERON and Induration > 0 mm	2 40%	4 80%	0 0%	1 2.2%
Positive QuantiFERON and Induration = 0 mm	9 180%	1 20%	9 20%	7 15.6%
Missing QuantiFERON result and/or Induration	0 0%	0 0%	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.
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

Outcome Measure Data

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
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.
Measure Participants	19	20	20	20
Positive QuantiFERON and Induration > 0 mm	0 0%	6 120%	5 11.1%	3 6.7%
Negative QuantiFERON and Induration = 0 mm	3 60%	1 20%	0 0%	1 2.2%
Negative QuantiFERON and Induration > 0 mm	0 0%	0 0%	0 0%	0 0%
Positive QuantiFERON and Induration = 0 mm	16 320%	11 220%	12 26.7%	13 28.9%
Missing QuantiFERON result and/or Induration	0 0%	2 40%	3 6.7%	3 6.7%

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.
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

Outcome Measure Data

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
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.
Measure Participants	20	20	20	20
Positive QuantiFERON and Induration > 0 mm	0 0%	2 40%	8 17.8%	4 8.9%
Negative QuantiFERON and Induration = 0 mm	9 180%	10 200%	3 6.7%	7 15.6%
Negative QuantiFERON and Induration > 0 mm	0 0%	1 20%	2 4.4%	6 13.3%
Positive QuantiFERON and Induration = 0 mm	11 220%	7 140%	7 15.6%	3 6.7%
Missing QuantiFERON result and/or Induration	0 0%	0 0%	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.
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

Outcome Measure Data

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
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.
Measure Participants	20	20	20	20	19	20	20	20
Positive QuantiFERON and Induration > 0 mm	10 200%	11 220%	15 33.3%	17 37.8%	9 45%	13 65%	14 70%	17 85%
Negative QuantiFERON and Induration = 0 mm	4 80%	3 60%	0 0%	1 2.2%	2 10%	0 0%	0 0%	0 0%
Negative QuantiFERON and Induration > 0 mm	1 20%	1 20%	2 4.4%	1 2.2%	0 0%	0 0%	0 0%	0 0%
Positive QuantiFERON and Induration = 0 mm	5 100%	5 100%	3 6.7%	1 2.2%	8 40%	5 25%	3 15%	0 0%
Missing QuantiFERON result and/or Induration	0 0%	0 0%	0 0%	0 0%	0 0%	2 10%	3 15%	3 15%

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
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

Outcome Measure Data

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
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.
Measure Participants	19	20	20	20
Pos PGL, Neg QuantiFERON and Induration = 0 mm	1 20%	0 0%	0 0%	0 0%
Neg PGL, Pos QuantiFERON and Induration > 0 mm	0 0%	3 60%	3 6.7%	0 0%
Pos PGL, Pos QuantiFERON and Induration > 0 mm	0 0%	2 40%	0 0%	1 2.2%
Neg PGL, Neg QuantiFERON and Induration = 0 mm	1 20%	1 20%	0 0%	1 2.2%
Neg PGL, Neg QuantiFERON and Induration = 0 mm	0 0%	0 0%	0 0%	0 0%
Pos PGL, Neg QuantiFERON and Induration > 0 mm	0 0%	0 0%	0 0%	0 0%
Neg PGL, Pos QuantiFERON and Induration > 0 mm	4 80%	6 120%	11 24.4%	13 28.9%
Pos PGL, Pos QuantiFERON and Induration = 0 mm	13 260%	6 120%	3 6.7%	2 4.4%
Missing Either Assay Result or Induration	0 0%	2 40%	3 6.7%	3 6.7%

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
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

Outcome Measure Data

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
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.
Measure Participants	20	20	20	20
Pos PGL, Neg QuantiFERON and Induration = 0 mm	3 60%	10 200%	6 13.3%	12 26.7%
Neg PGL, Pos QuantiFERON and Induration > 0 mm	2 40%	1 20%	0 0%	0 0%
Pos PGL, Pos QuantiFERON and Induration > 0 mm	2 40%	4 80%	2 4.4%	0 0%
Neg PGL, Neg QuantiFERON and Induration = 0 mm	2 40%	0 0%	2 4.4%	0 0%
Neg PGL, Neg QuantiFERON and Induration = 0 mm	0 0%	2 40%	0 0%	0 0%
Pos PGL, Neg QuantiFERON and Induration > 0 mm	2 40%	2 40%	0 0%	1 2.2%
Neg PGL, Pos QuantiFERON and Induration > 0 mm	4 80%	0 0%	5 11.1%	0 0%
Pos PGL, Pos QuantiFERON and Induration = 0 mm	5 100%	1 20%	4 8.9%	7 15.6%
Missing Either Assay Result or Induration	0 0%	0 0%	1 2.2%	0 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
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

Outcome Measure Data

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
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.
Measure Participants	19	20	20	20
Pos PGL, Neg QuantiFERON and Induration = 0 mm	2 40%	0 0%	0 0%	0 0%
Neg PGL, Pos QuantiFERON and Induration > 0 mm	0 0%	4 80%	5 11.1%	2 4.4%
Pos PGL, Pos QuantiFERON and Induration > 0 mm	0 0%	2 40%	0 0%	1 2.2%
Neg PGL, Neg QuantiFERON and Induration = 0 mm	1 20%	1 20%	0 0%	1 2.2%
Neg PGL, Neg QuantiFERON and Induration = 0 mm	0 0%	0 0%	0 0%	0 0%
Pos PGL, Neg QuantiFERON and Induration > 0 mm	0 0%	0 0%	0 0%	0 0%
Neg PGL, Pos QuantiFERON and Induration > 0 mm	4 80%	5 100%	9 20%	11 24.4%
Pos PGL, Pos QuantiFERON and Induration = 0 mm	12 240%	6 120%	3 6.7%	2 4.4%
Missing Either Assay Result or Induration	0 0%	2 40%	3 6.7%	3 6.7%

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
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

Outcome Measure Data

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
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.
Measure Participants	20	20	20	20
Pos PGL, Neg QuantiFERON and Induration = 0 mm	9 180%	7 140%	1 2.2%	6 13.3%
Neg PGL, Pos QuantiFERON and Induration > 0 mm	0 0%	0 0%	5 11.1%	1 2.2%
Pos PGL, Pos QuantiFERON and Induration > 0 mm	0 0%	2 40%	3 6.7%	3 6.7%
Neg PGL, Neg QuantiFERON and Induration = 0 mm	0 0%	3 60%	2 4.4%	1 2.2%
Neg PGL, Neg QuantiFERON and Induration = 0 mm	0 0%	0 0%	0 0%	1 2.2%
Pos PGL, Neg QuantiFERON and Induration > 0 mm	0 0%	0 0%	2 4.4%	5 11.1%
Neg PGL, Pos QuantiFERON and Induration > 0 mm	0 0%	4 80%	1 2.2%	0 0%
Pos PGL, Pos QuantiFERON and Induration = 0 mm	11 220%	3 60%	6 13.3%	3 6.7%
Missing Either Assay Result or Induration	0 0%	1 20%	0 0%	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
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

Outcome Measure Data

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
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.
Measure Participants	20	20	20	20	19	20	20	20
Pos PGL, Neg QuantiFERON and Induration = 0 mm	4 80%	0 0%	0 0%	1 2.2%	1 5%	0 0%	0 0%	0 0%
Neg PGL, Pos QuantiFERON and Induration > 0 mm	0 0%	4 80%	5 11.1%	3 6.7%	2 10%	6 30%	12 60%	14 70%
Pos PGL, Pos QuantiFERON and Induration > 0 mm	10 200%	7 140%	10 22.2%	14 31.1%	7 35%	7 35%	2 10%	3 15%
Neg PGL, Neg QuantiFERON and Induration = 0 mm	0 0%	2 40%	0 0%	0 0%	1 5%	0 0%	0 0%	0 0%
Neg PGL, Neg QuantiFERON and Induration = 0 mm	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Pos PGL, Neg QuantiFERON and Induration > 0 mm	1 20%	1 20%	2 4.4%	1 2.2%	0 0%	0 0%	0 0%	0 0%
Neg PGL, Pos QuantiFERON and Induration > 0 mm	0 0%	1 20%	3 6.7%	0 0%	2 10%	4 20%	2 10%	0 0%
Pos PGL, Pos QuantiFERON and Induration = 0 mm	5 100%	4 80%	0 0%	1 2.2%	6 30%	1 5%	1 5%	0 0%
Missing Either Assay Result or Induration	0 0%	1 20%	0 0%	0 0%	0 0%	2 10%	3 15%	3 15%

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
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
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
	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	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
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%)		0/5 (0%)		2/45 (4.4%)		0/45 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Infections and infestations
Appendicitis	0/5 (0%)	0	0/5 (0%)	0	1/45 (2.2%)	1	0/45 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Nervous system disorders
Cerebral haemorrhage	0/5 (0%)	0	0/5 (0%)	0	1/45 (2.2%)	1	0/45 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Other (Not Including 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	5/5 (100%)		4/5 (80%)		36/45 (80%)		35/45 (77.8%)		13/20 (65%)		15/20 (75%)		19/20 (95%)		20/20 (100%)		11/20 (55%)		16/20 (80%)		18/20 (90%)		20/20 (100%)
General disorders
Induration	5/5 (100%)	6	4/5 (80%)	5	34/45 (75.6%)	46	31/45 (68.9%)	42	12/20 (60%)	12	14/20 (70%)	16	18/20 (90%)	30	18/20 (90%)	34	9/20 (45%)	11	15/20 (75%)	20	17/20 (85%)	22	20/20 (100%)	21
Pain	1/5 (20%)	1	2/5 (40%)	2	14/45 (31.1%)	16	13/45 (28.9%)	13	7/20 (35%)	8	8/20 (40%)	8	5/20 (25%)	7	9/20 (45%)	11	3/20 (15%)	3	1/20 (5%)	1	4/20 (20%)	4	3/20 (15%)	3
Immune system disorders
Type IV hypersensitivity reaction	0/5 (0%)	0	0/5 (0%)	0	0/45 (0%)	0	0/45 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	1/20 (5%)	1	0/20 (0%)	0	0/20 (0%)	0
Infections and infestations
Infection	0/5 (0%)	0	0/5 (0%)	0	0/45 (0%)	0	0/45 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	1/20 (5%)	1	0/20 (0%)	0	0/20 (0%)	0	1/20 (5%)	1	0/20 (0%)	0
Skin and subcutaneous tissue disorders
Erythema	5/5 (100%)	9	4/5 (80%)	7	36/45 (80%)	46	34/45 (75.6%)	45	13/20 (65%)	16	15/20 (75%)	22	19/20 (95%)	36	20/20 (100%)	46	11/20 (55%)	11	16/20 (80%)	27	18/20 (90%)	26	20/20 (100%)	27
Pruritis	0/5 (0%)	0	0/5 (0%)	0	17/45 (37.8%)	17	17/45 (37.8%)	18	5/20 (25%)	5	6/20 (30%)	6	10/20 (50%)	25	15/20 (75%)	21	0/20 (0%)	0	9/20 (45%)	11	6/20 (30%)	7	12/20 (60%)	12
Urticaria	1/5 (20%)	1	2/5 (40%)	2	0/45 (0%)	0	1/45 (2.2%)	1	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	1/20 (5%)	1	0/20 (0%)	0	0/20 (0%)	0	1/20 (5%)	1	0/20 (0%)	0
Blister	1/5 (20%)	1	0/5 (0%)	0	0/45 (0%)	0	4/45 (8.9%)	4	2/20 (10%)	2	0/20 (0%)	0	1/20 (5%)	1	1/20 (5%)	1	0/20 (0%)	0	0/20 (0%)	0	2/20 (10%)	2	0/20 (0%)	0
Vascular disorders
Haemorrhage	0/5 (0%)	0	0/5 (0%)	0	0/45 (0%)	0	0/45 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0	1/20 (5%)	1	0/20 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

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
Email	patrick.brennan@colostate.edu

Responsible Party:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00128193

Other Study ID Numbers:

00-002

First Posted:

Aug 9, 2005

Last Update Posted:

Dec 24, 2014

Last Verified:

Aug 1, 2010

Leprosy Skin Test Antigens Trial

Study Details

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