Leprosy Skin Test Antigens Trial | NCT00128193 | Trialant
NCT00128193
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Status
Completed
Last Update Posted
Dec 24, 2014Estimated
Enrollment
260Actual
Phase
Phase 2
Conditions
Leprosy
Interventions
Tuberculin, Purified Protein Derivative
MLSA-LAM
MLCwA
Tuberculin, Purified Protein Derivative
Placebo
Countries
United States
Nepal
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00128193
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
00-002
Secondary IDs
Not provided
Brief Title
Leprosy Skin Test Antigens Trial
Official Title
Two New Leprosy Skin Test Antigens: MLSA-LAM and MLCwA Phase II Study in a Leprosy-Endemic Region
Acronym
Not provided
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Aug 2010
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2002
Primary Completion Date
Sep 2009Actual
Completion Date
Sep 2009Actual
First Submitted Date
Aug 5, 2005
First Submission Date that Met QC Criteria
Aug 5, 2005
First Posted Date
Aug 9, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 30, 2010
Results First Submitted that Met QC Criteria
Sep 30, 2010
Results First Posted Date
Nov 1, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 4, 2014
Last Update Posted Date
Dec 24, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
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.
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 M. leprae specific anti
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
Biological: Tuberculin, Purified Protein Derivative
Other: Placebo
C1-Target Population
Experimental
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
Other: MLSA-LAM
Other: MLCwA
C-1b-Target Population (Low Dose)
Experimental
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
Other: MLSA-LAM
Other: MLCwA
B2-Full-Scale (MLCwA)
Experimental
45 subjects to receive: 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl).
Other: MLCwA
Biological: Tuberculin, Purified Protein Derivative
Other: Placebo
B1-Full-Scale (MLSA-LAM)
Experimental
45 subjects to receive: 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Tuberculin, Purified Protein Derivative
Biological
A tuberculin skin test used to diagnose latent tuberculosis (TB) infection. 2 TU dose
C-1b-Target Population (Low Dose)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram
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.
Up to 28 Days
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
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.
Up to 28 Days
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram
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.
Up to 28 Days
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
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.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
60 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Colorado State University - Microbiology, Immunology & Pathology
Rivoire BL, Groathouse NA, TerLouw S, Neupane KD, Ranjit C, Sapkota BR, Khadge S, Kunwar CB, Macdonald M, Hawksworth R, Thapa MB, Hagge DA, Tibbals M, Smith C, Dube T, She D, Wolff M, Zhou E, Makhene M, Mason R, Sizemore C, Brennan PJ. Safety and efficacy assessment of two new leprosy skin test antigens: randomized double blind clinical study. PLoS Negl Trop Dis. 2014 May 29;8(5):e2811. doi: 10.1371/journal.pntd.0002811. eCollection 2014.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
A1 - MLSA in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
FG001
A2 - MLC in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
FG002
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
FG003
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
FG004
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
FG005
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
FG006
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
FG007
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
FG008
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
FG009
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
FG010
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
FG011
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0005 subjects
FG0015 subjects
FG00245 subjects
FG00345 subjects
FG00420 subjects
FG00520 subjects
FG00620 subjects
FG00720 subjects
FG00820 subjects
FG00920 subjects
FG01020 subjects
FG01120 subjects
COMPLETED
FG0005 subjects
FG0015 subjects
FG00242 subjects
FG00344 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG004
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
A1 - MLSA in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram
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.
All participants who received the antigen are included in the analysis population.
Posted
Number
Participants
Up to 28 Days
ID
Title
Description
OG000
A1 - MLSA in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
Adverse Events Module
Frequency Threshold
5
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.
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
A1 - MLSA in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis
Infections and infestations
MedDRA (7.0)
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Erythema
Skin and subcutaneous tissue disorders
MedDRA 13.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Patrick J. Brennan, Ph.D.
Colorado State University, Department of Microbiology, Immunology and Pathology
970-491-6700
patrick.brennan@colostate.edu
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D007918
Leprosy
Ancestor Terms
ID
Term
D009165
Mycobacterium Infections, Nontuberculous
D009164
Mycobacterium Infections
D000193
Actinomycetales Infections
D016908
Gram-Positive Bacterial Infections
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D014373
Tuberculin
Ancestor Terms
ID
Term
D000942
Antigens, Bacterial
D001426
Bacterial Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Diagnostic
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Other: MLSA-LAM
Biological: Tuberculin, Purified Protein Derivative
Other: Placebo
A2-Ramping (MLCwA)
Experimental
5 subjects to receive: 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl).
Other: MLCwA
Biological: Tuberculin, Purified Protein Derivative
Other: Placebo
C1-Target Population
MLSA-LAM
Other
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).
A1-Ramping (MLSA-LAM)
B1-Full-Scale (MLSA-LAM)
C-1b-Target Population (Low Dose)
C1-Target Population
MLCwA
Other
Cell wall-associated proteins of Mycobacterium leprae; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl).
A2-Ramping (MLCwA)
B2-Full-Scale (MLCwA)
C-1b-Target Population (Low Dose)
C1-Target Population
Tuberculin, Purified Protein Derivative
Biological
Licensed TB reagent, 100 microliters, 5 TU dose.
A1-Ramping (MLSA-LAM)
A2-Ramping (MLCwA)
B1-Full-Scale (MLSA-LAM)
B2-Full-Scale (MLCwA)
Placebo
Other
Saline (NaCl) serves as a diluent control in Stage A and B only.
A1-Ramping (MLSA-LAM)
A2-Ramping (MLCwA)
B1-Full-Scale (MLSA-LAM)
B2-Full-Scale (MLCwA)
Up to 28 Days
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram
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.
Up to 28 Days
Number of Participants With Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram
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.
Up to 28 Days
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram
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.
Up to 28 Days
Number of Participants With the Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram
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.
Up to 28 Days
Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD)
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.
Up to 28 Days
Number of Participants With the Reaction of Itching to the Antigen Purified Protein Derivative (PPD)
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.
Up to 28 Days
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
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.
Day 3
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
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.
Day 7
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
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.
Day 3
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
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.
Day 7
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms
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.
Day 3
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms
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.
Day 7
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
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.
Day 3
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
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.
Day 7
Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)
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.
Day 3
Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)
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.
Day 7
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
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).
Day 3
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
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).
Day 7
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
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).
Day 2
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
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).
Day 3
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
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).
Day 7
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms
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).
Day 3
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms
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).
Day 7
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
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).
Day 2
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
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).
Day 3
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
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).
Day 7
Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)
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).
Day 2
Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)
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).
Day 3
Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)
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).
Day 7
Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)
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).
Day 28
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.
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.
Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
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.
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.
Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
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.
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.
Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
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.
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.
Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen PPD.
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.
Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
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
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.
Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
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
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.
Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
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
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.
Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
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
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.
Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
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
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.
Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
Anandaban Hospital
Kathmandu
Nepal
Green Pastures Hospitals
Kathmandu
Nepal
Lalitpur Nursing Campus
Kathmandu
Nepal
Patan Hospital
Kathmandu
Nepal
Tribhuvan University - Anandaban Hospital
Kathmandu
Nepal
18 subjects
FG00517 subjects
FG00616 subjects
FG00720 subjects
FG00818 subjects
FG00918 subjects
FG01017 subjects
FG01118 subjects
2 subjects
FG0053 subjects
FG0064 subjects
FG0070 subjects
FG0082 subjects
FG0092 subjects
FG0103 subjects
FG0112 subjects
A2 - MLC in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
BG002
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
BG003
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
BG004
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
BG005
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
BG006
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
BG007
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
BG008
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
BG009
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
BG010
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
BG011
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
BG012
Total
Total of all reporting groups
5
BG0015
BG00245
BG00345
BG00420
BG00520
BG00620
BG00720
BG00820
BG00920
BG01020
BG01120
BG012260
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG00213
BG00310
BG0040
BG0050
BG0060
BG0074
BG0080
BG0091
BG0104
BG0111
BG01233
Between 18 and 65 years
BG0005
BG0015
BG00232
BG00335
BG004
>=65 years
BG0000
BG0010
BG0020
BG0030
BG004
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00030.6± 6.4
BG00129.4± 2.9
BG00221.1± 5.3
BG00323.1± 6.7
BG00437.5± 12.3
BG00532.9± 12.9
BG00632.9± 11.0
BG00726.0± 7.7
BG00835.2± 13.1
BG00939.0± 13.5
BG01030.2± 12.1
BG01131.1± 13.1
BG01228.5± 11.3
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0014
BG00214
BG0038
BG0046
BG0056
BG0067
BG0077
BG0085
BG0094
BG01014
BG0115
BG01284
Male
BG0001
BG0011
BG00231
BG00337
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
Nepal
Title
Measurements
BG0005
BG0015
BG00245
BG00345
BG00420
BG00520
BG00620
BG00720
BG00820
BG00920
BG01020
BG01120
BG012260
OG001
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG002
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
OG003
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG004
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG005
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0005
OG00145
OG00220
OG00320
OG00420
OG00520
Title
Denominators
Categories
Erythema
Title
Measurements
OG0000
OG0013
OG0021
OG0035
OG0044
OG0052
Induration
Title
Measurements
OG0000
OG0012
OG0020
OG003
Pain/Tenderness
Title
Measurements
OG0000
OG0011
OG0020
OG003
Bleeding
Title
Measurements
OG0000
OG0010
OG0020
OG003
Urticaria
Title
Measurements
OG0000
OG0010
OG0020
OG003
Infection
Title
Measurements
OG0000
OG0010
OG0020
OG003
Blistering/Ulcerating
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
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
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.
All participants in Groups B and C who received the antigen are included in the analysis population.
Posted
Number
Participants
Up to 28 Days
ID
Title
Description
OG000
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG001
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
OG002
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG003
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG004
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00045
OG00120
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Number of Participants With Reactions to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Microgram
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.
All participants who received the antigen are included in the analysis population.
Posted
Number
Participants
Up to 28 Days
ID
Title
Description
OG000
A1 - MLSA in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
OG001
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG002
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG004
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG005
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Units
Counts
Participants
OG0005
OG00145
OG00220
OG003
Title
Denominators
Categories
Erythema
Title
Measurements
OG0004
OG00110
OG0022
OG003
Primary
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
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.
All participants in Groups B and C who received the antigen are included in the analysis population.
Posted
Number
Participants
Up to 28 Days
ID
Title
Description
OG000
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG001
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG002
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG004
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Units
Counts
Participants
OG00045
OG00120
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram
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.
All participants who received the antigen are included in the analysis population.
Posted
Number
Participants
Up to 28 Days
ID
Title
Description
OG000
A2 - MLC in Healthy Non-Exposed Participants
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)
OG001
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG002
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
OG003
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG004
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG005
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0005
OG00145
OG00220
OG003
Title
Denominators
Categories
Erythema
Title
Measurements
OG0000
OG0011
OG0021
OG003
Primary
Number of Participants With Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram
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.
Posted
Number
Participants
Up to 28 Days
ID
Title
Description
OG000
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG001
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
OG002
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG003
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG004
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00045
OG00120
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0022
OG003
Primary
Number of Participants With Reactions to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram
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.
All participants who received the antigen are included in the analysis population.
Posted
Number
Participants
Up to 28 Days
ID
Title
Description
OG000
A2 - MLC in Healthy Non-Exposed Participants
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)
OG001
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG002
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG004
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG005
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Units
Counts
Participants
OG0005
OG00145
OG00220
OG003
Title
Denominators
Categories
Erythema
Title
Measurements
OG0003
OG00111
OG0022
OG003
Primary
Number of Participants With the Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram
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.
All participants in Groups B and C who received the antigen are included in the analysis population.
Posted
Number
Participants
Up to 28 Days
ID
Title
Description
OG000
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG001
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG002
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG004
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Units
Counts
Participants
OG00045
OG00120
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0021
OG003
Primary
Number of Participants With Reactions to the Antigen Purified Protein Derivative (PPD)
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.
All participants who received the antigen are included in the analysis population.
Posted
Number
Participants
Up to 28 Days
ID
Title
Description
OG000
A1 - MLSA in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
OG001
A2 - MLC in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG002
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG003
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG004
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG005
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG006
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG007
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG008
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
OG009
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG010
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG011
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0005
OG0015
OG00245
OG003
Title
Denominators
Categories
Erythema
Title
Measurements
OG0005
OG0014
OG00233
OG003
Primary
Number of Participants With the Reaction of Itching to the Antigen Purified Protein Derivative (PPD)
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.
All participants in Groups B and C who received the antigen are included in the analysis population.
Posted
Number
Participants
Up to 28 Days
ID
Title
Description
OG000
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG001
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG002
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG003
C1 - High Dose in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG004
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG005
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG006
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG007
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG008
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG009
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00045
OG00145
OG00220
OG003
Title
Denominators
Categories
Title
Measurements
OG00017
OG00117
OG0025
OG003
Primary
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
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.
The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 3
ID
Title
Description
OG000
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG001
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG002
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0005
OG0014
OG0022
Title
Denominators
Categories
Title
Measurements
OG00012.6± 4.2
OG0019.8± 1.8
OG0029.3± 0.6
Primary
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
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.
The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 7
ID
Title
Description
OG000
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG001
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG002
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0004
OG0013
OG0023
Title
Denominators
Categories
Title
Measurements
OG00011.3± 3.4
OG00110.3± 0.8
OG0029.8± 2.4
Primary
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
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.
The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 3
ID
Title
Description
OG000
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG001
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Units
Counts
Participants
OG0001
OG0012
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG00123.3± 4.6
OG00213.0± 5.9
OG003
Primary
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
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.
The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 7
ID
Title
Description
OG000
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG001
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Units
Counts
Participants
OG0001
OG0012
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG00016.0
OG00120.3± 5.3
OG00213.8± 6.6
OG003
Primary
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms
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.
The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 3
ID
Title
Description
OG000
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG001
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG002
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0007
OG0016
OG0025
Title
Denominators
Categories
Title
Measurements
OG00015.1± 3.3
OG00113.0± 4.6
OG0029.6± 2.3
Primary
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms
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.
The analysis population is restricted to participants in Group C1b who had measurable erythema at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 7
ID
Title
Description
OG000
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG001
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG002
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0005
OG0016
OG0024
Title
Denominators
Categories
Title
Measurements
OG00012.1± 5.0
OG00112.2± 3.4
OG0028.9± 1.4
Primary
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
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.
The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 3
ID
Title
Description
OG000
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG001
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Units
Counts
Participants
OG0001
OG0013
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.0
OG00120.8± 2.9
OG00214.7± 5.7
OG003
Primary
Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
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.
The analysis population is restricted to participants in Group C1 who had measurable erythema at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 7
ID
Title
Description
OG000
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG001
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG002
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Units
Counts
Participants
OG0003
OG0018
OG00211
Title
Denominators
Categories
Title
Measurements
OG00017.8± 7.0
OG00116.4± 5.1
OG00213.8± 5.3
Primary
Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)
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.
The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 3
ID
Title
Description
OG000
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG001
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG004
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
OG005
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG006
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG007
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00012
OG00112
OG00216
OG003
Title
Denominators
Categories
Title
Measurements
OG00020.4± 9.4
OG00120.7± 8.0
OG00219.3± 9.8
OG003
Primary
Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD)
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.
The analysis population is restricted to participants in Group C1 and C1b who had measurable erythema at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 7
ID
Title
Description
OG000
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG001
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG004
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
OG005
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG006
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG007
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0009
OG00112
OG00216
OG003
Title
Denominators
Categories
Title
Measurements
OG00018.6± 5.4
OG00119.0± 6.5
OG00217.8± 5.7
OG003
Primary
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
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).
The analysis population is restricted to participants who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 3
ID
Title
Description
OG000
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG001
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG002
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0002
OG0014
OG0022
Title
Denominators
Categories
Title
Measurements
OG0005.0± 3.5
OG00114.0± 3.2
OG00210.8± 1.1
Primary
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
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).
The analysis population is restricted to participants in Groups B1 and C1b who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 7
ID
Title
Description
OG000
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG001
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG002
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0001
OG0014
OG0023
Title
Denominators
Categories
Title
Measurements
OG0004.5
OG00111.3± 3.4
OG00210.3± 0.8
Primary
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
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).
The analysis population is restricted to participants in Group A1 who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 2
ID
Title
Description
OG000
A1 - MLSA in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
Units
Counts
Participants
OG0001
Title
Denominators
Categories
Title
Measurements
OG00025.0
Primary
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
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).
The analysis population is restricted to participants in Groups A1, B1 and C1 who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 3
ID
Title
Description
OG000
A1 - MLSA in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
OG001
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG002
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG004
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG005
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Units
Counts
Participants
OG0001
OG0019
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG0019.4± 5.5
OG00220.0
OG003
Primary
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
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).
The analysis population is restricted to participants in Groups B1 and C1 who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 7
ID
Title
Description
OG000
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG001
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG002
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG004
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Units
Counts
Participants
OG00012
OG0011
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG0008.1± 3.4
OG00116
OG00216.3± 9.5
OG003
Primary
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms
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).
The analysis population is restricted to participants in Groups A2, B2 and C1b who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 3
ID
Title
Description
OG000
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG001
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG002
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0005
OG0014
OG0023
Title
Denominators
Categories
Title
Measurements
OG00014.8± 4
OG00111.5± 5.1
OG0028.3± 2.1
Primary
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms
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).
The analysis population is restricted to participants in Groups B2 and C1b who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 7
ID
Title
Description
OG000
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG001
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG002
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG003
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0001
OG0015
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.0
OG00111.4± 4.0
OG00211.8± 3.7
OG003
Primary
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
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).
The analysis population is restricted to participants in Group A2 who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 2
ID
Title
Description
OG000
A2 - MLC in Healthy Non-Exposed Participants
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)
Units
Counts
Participants
OG0001
Title
Denominators
Categories
Title
Measurements
OG00025.0
Primary
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
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).
The analysis population is restricted to participants in Groups A2, B2 and C1 who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 3
ID
Title
Description
OG000
A2 - MLC in Healthy Non-Exposed Participants
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)
OG001
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG002
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG004
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Units
Counts
Participants
OG0001
OG0017
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG00016.5
OG0019.8± 5.1
OG00220.1± 1.3
OG003
Primary
Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms
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).
The analysis population is restricted to participants in Groups B2 and C1 who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 7
ID
Title
Description
OG000
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG001
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
Units
Counts
Participants
OG00010
OG0011
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.0± 4.7
OG00123.5
OG00213.8± 7.5
OG003
Primary
Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)
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).
The analysis population is restricted to participants in Groups A1 and A2 who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 2
ID
Title
Description
OG000
A1 - MLSA in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
OG001
A2 - MLC in Healthy Non-Exposed Participants
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)
Units
Counts
Participants
OG0005
OG0014
Title
Denominators
Categories
Title
Measurements
OG00019.3± 15.2
OG00125.5± 11.0
Primary
Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)
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).
The analysis population is restricted to participants in all groups who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 3
ID
Title
Description
OG000
A1 - MLSA in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
OG001
A2 - MLC in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG002
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG003
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG004
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG005
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG006
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG007
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG008
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
OG009
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG010
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG011
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0005
OG0014
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG00019.1± 9.7
OG00120.5± 8.2
OG00215.1± 5.6
OG003
Primary
Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)
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).
The analysis population is restricted to participants in Groups B1, B2, C1 and C1b who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 7
ID
Title
Description
OG000
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG001
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG002
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG003
C1 - High Dose in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG004
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG005
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG006
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG007
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG008
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG009
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00033
OG00131
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00014.0± 5.7
OG00116.0± 5.6
OG00218.3± 5.8
OG003
Primary
Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD)
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).
The analysis population is restricted to participants in all groups who had measurable induration at the time of assessment.
Posted
Mean
Standard Deviation
Millimeters
Day 28
ID
Title
Description
OG000
A1 - MLSA in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
OG001
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
OG003
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG0001
OG0014
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG00016.0
OG00113.5± 0
OG0028.0
OG003
Primary
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.
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.
All evaluable participants in Group C1b who received the antigen are included in the analysis population.
Posted
Number
Participants
Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
ID
Title
Description
OG000
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG001
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG002
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG003
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00019
OG00120
OG00220
OG003
Title
Denominators
Categories
Positive QuantiFERON and Induration > 0 mm
Title
Measurements
OG0000
OG0015
OG0023
OG003
Primary
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.
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.
All participants in Group C1 who received the antigen are included in the analysis population.
Posted
Number
Participants
Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
ID
Title
Description
OG000
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG001
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG003
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG003
Title
Denominators
Categories
Positive QuantiFERON and Induration > 0 mm
Title
Measurements
OG0004
OG0015
OG0022
OG003
Primary
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.
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.
All evaluable participants in Group C1b who received the antigen are included in the analysis population.
Posted
Number
Participants
Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
ID
Title
Description
OG000
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG001
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG002
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG003
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00019
OG00120
OG00220
OG003
Title
Denominators
Categories
Positive QuantiFERON and Induration > 0 mm
Title
Measurements
OG0000
OG0016
OG0025
OG003
Primary
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.
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.
All participants in Group C1 who received the antigen are included in the analysis population.
Posted
Number
Participants
Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
ID
Title
Description
OG000
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG001
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG003
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG003
Title
Denominators
Categories
Positive QuantiFERON and Induration > 0 mm
Title
Measurements
OG0000
OG0012
OG0028
OG003
Primary
Number of Participants With QuantiFERON Responses Based on the Presence or Absence of Induration at the Injection Site for the Antigen PPD.
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.
All evaluable participants in Groups C1 and C1b who received the antigen are included in the analysis population.
Posted
Number
Participants
Day 0 for QuantiFERON; Days 3, 7, and 28 for induration
ID
Title
Description
OG000
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG001
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG003
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG004
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG005
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG006
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG007
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG003
Title
Denominators
Categories
Positive QuantiFERON and Induration > 0 mm
Title
Measurements
OG00010
OG00111
OG00215
OG003
Primary
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
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.
All evaluable participants in Group C1b who received the antigen are included in the analysis population.
Posted
Number
Participants
Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
ID
Title
Description
OG000
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG001
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG002
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG003
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00019
OG00120
OG00220
OG003
Title
Denominators
Categories
Pos PGL, Neg QuantiFERON and Induration = 0 mm
Title
Measurements
OG0001
OG0010
OG0020
OG003
Primary
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
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.
All participants in Group C1 who received the antigen are included in the analysis population.
Posted
Number
Participants
Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
ID
Title
Description
OG000
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG001
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG003
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG003
Title
Denominators
Categories
Pos PGL, Neg QuantiFERON and Induration = 0 mm
Title
Measurements
OG0003
OG00110
OG0026
OG003
Primary
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
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.
All evaluable participants in Group C1b who received the antigen are included in the analysis population.
Posted
Number
Participants
Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
ID
Title
Description
OG000
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG001
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG002
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG003
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00019
OG00120
OG00220
OG003
Title
Denominators
Categories
Pos PGL, Neg QuantiFERON and Induration = 0 mm
Title
Measurements
OG0002
OG0010
OG0020
OG003
Primary
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
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.
All participants in Group C1 who received the antigen are included in the analysis population.
Posted
Number
Participants
Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
ID
Title
Description
OG000
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG001
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG003
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG003
Title
Denominators
Categories
Pos PGL, Neg QuantiFERON and Induration = 0 mm
Title
Measurements
OG0009
OG0017
OG0021
OG003
Primary
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
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.
All evaluable participants in Group C1 and C1b who received the antigen are included in the analysis population.
Posted
Number
Participants
Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
ID
Title
Description
OG000
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG001
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG002
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG003
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
OG004
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG005
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG006
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
OG007
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
Units
Counts
Participants
OG00020
OG00120
OG00220
OG003
Title
Denominators
Categories
Pos PGL, Neg QuantiFERON and Induration = 0 mm
Title
Measurements
OG0004
OG0010
OG0020
OG003
0
5
5
5
EG001
A2 - MLC in Healthy Non-Exposed Participants
5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
0
5
4
5
EG002
B1 - MLSA in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
2
45
36
45
EG003
B2 - MLC in Healthy Non-Exposed Participants
45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
0
45
35
45
EG004
C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
0
20
13
20
EG005
C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
0
20
15
20
EG006
C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
0
20
19
20
EG007
CI - High Dose MLSA and MLC in TB Patients
20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
0
20
20
20
EG008
C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients
20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
0
20
11
20
EG009
C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients
20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
0
20
16
20
EG010
C1b - Low Dose MLSA and MLC in Healthy Contacts
20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
0
20
18
20
EG011
C1b - Low Dose MLSA and MLC in TB Patients
20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.