A Phase 2 interventional study of Tuberculin, Purified Protein Derivative and MLSA-LAM in Leprosy, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 6 sites in 2 countries. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-24.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Diagnostic
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.
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
52 studies on the registry are indexed under Leprosy; 13 are open to participants now.
This study's enrollment of 260 is above the median of 70 across 41 interventional studies indexed under Leprosy.
Browse Leprosy studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All Subjects
Healthy, Non-Contacts
Contacts of Leprosy Patients
Persons with Leprosy
Having one or more of the following symptoms:
Persons with Tuberculosis
Having active tuberculosis as defined by one of the following:
Exclusion Criteria:
All subjects
Healthy, Non-Contacts
Healthy Contacts of Leprosy Patients
Persons with Leprosy
Persons with Tuberculosis
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
45 subjects to receive: 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl).
Other: MLSA-LAM · Biological: Tuberculin, Purified Protein Derivative · Other: Placebo
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
A tuberculin skin test used to diagnose latent tuberculosis (TB) infection. 2 TU dose
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).
Cell wall-associated proteins of Mycobacterium leprae; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl).
Licensed TB reagent, 100 microliters, 5 TU dose.
Saline (NaCl) serves as a diluent control in Stage A and B only.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 0 for PGL-1 and QuantiFERON; Days 3, 7, and 28 for induration
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.
| Milestone | A1 - MLSA in Healthy Non-Exposed Participants | A2 - MLC in Healthy Non-Exposed Participants | B1 - MLSA in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 5 | 5 | 45 | 45 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Completed | 5 | 5 | 42 | 44 | 18 | 17 | 16 | 20 | 18 | 18 | 17 | 18 |
| Not completed | 0 | 0 | 3 | 1 | 2 | 3 | 4 | 0 | 2 | 2 | 3 | 2 |
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.
| Participants | A1 - MLSA in Healthy Non-Exposed Participants | B1 - MLSA in Healthy Non-Exposed Participants | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|
| Erythema | 0 | 3 | 1 | 5 | 4 | 2 |
| Induration | 0 | 2 | 0 | 4 | 2 | 0 |
| Pain/Tenderness | 0 | 1 | 0 | 0 | 1 | 0 |
| Bleeding | 0 | 0 | 0 | 0 | 1 | 0 |
| Urticaria | 0 | 0 | 0 | 0 | 1 | 0 |
| Infection | 0 | 0 | 0 | 0 | 1 | 0 |
| Blistering/Ulcerating | 0 | 0 | 0 | 0 | 1 | 0 |
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.
| Participants | B1 - MLSA in Healthy Non-Exposed Participants | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|
| Number of Participants With the Reaction of Itching to the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 0.1 Microgram | 0 | 0 | 1 | 1 | 0 |
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.
| Participants | A1 - MLSA in Healthy Non-Exposed Participants | B1 - MLSA in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|
| Erythema | 4 | 10 | 2 | 4 | 11 | 12 |
| Induration | 1 | 12 | 1 | 2 | 5 | 7 |
| Pain/Tenderness | 0 | 3 | 1 | 0 | 1 | 0 |
| Bleeding | 0 | 0 | 0 | 0 | 0 | 0 |
| Urticaria | 0 | 0 | 0 | 0 | 0 | 1 |
| Infection | 0 | 0 | 0 | 0 | 0 | 1 |
| Blistering/Ulcerating | 0 | 0 | 0 | 0 | 0 | 1 |
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.
| Participants | B1 - MLSA in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|
| 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 | 0 | 0 | 0 | 4 | 1 |
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.
| Participants | A2 - MLC in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|
| Erythema | 0 | 1 | 1 | 8 | 5 | 5 |
| Induration | 0 | 1 | 0 | 5 | 5 | 3 |
| Pain/Tenderness | 0 | 0 | 0 | 0 | 0 | 0 |
| Bleeding | 0 | 0 | 0 | 0 | 0 | 0 |
| Urticaria | 0 | 0 | 0 | 0 | 0 | 0 |
| Infection | 0 | 0 | 0 | 0 | 0 | 0 |
| Blistering/Ulcerating | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | B2 - MLC in Healthy Non-Exposed Participants | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|
| Number of Participants With Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Microgram | 0 | 0 | 2 | 1 | 0 |
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.
| Participants | A2 - MLC in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|
| Erythema | 3 | 11 | 2 | 5 | 8 | 14 |
| Induration | 1 | 10 | 0 | 3 | 9 | 9 |
| Pain/Tenderness | 0 | 0 | 1 | 1 | 1 | 2 |
| Bleeding | 0 | 0 | 0 | 0 | 0 | 0 |
| Urticaria | 0 | 0 | 0 | 0 | 0 | 0 |
| Infection | 0 | 0 | 0 | 0 | 0 | 0 |
| Blistering/Ulcerating | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|
| Number of Participants With the Reaction of Itching to the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Microgram | 1 | 0 | 1 | 5 | 6 |
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.
| Participants | A1 - MLSA in Healthy Non-Exposed Participants | A2 - MLC in Healthy Non-Exposed Participants | B1 - MLSA in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Erythema | 5 | 4 | 33 | 33 | 12 | 13 | 17 | 20 | 9 | 14 | 17 | 20 |
| Induration | 5 | 4 | 33 | 31 | 11 | 11 | 16 | 18 | 11 | 11 | 16 | 18 |
| Pain/Tenderness | 1 | 2 | 12 | 13 | 6 | 7 | 5 | 9 | 3 | 1 | 3 | 3 |
| Bleeding | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Urticaria | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Infection | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Blistering/Ulcerating | 1 | 0 | 0 | 4 | 2 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
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.
| Participants | B1 - MLSA in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With the Reaction of Itching to the Antigen Purified Protein Derivative (PPD) | 17 | 17 | 5 | 5 | 9 | 14 | 0 | 8 | 5 | 12 |
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.
| Millimeters | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|
| 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 | 12.6 ± 4.2 | 9.8 ± 1.8 | 9.3 ± 0.6 |
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.
| Millimeters | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|
| 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 | 11.3 ± 3.4 | 10.3 ± 0.8 | 9.8 ± 2.4 |
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.
| Millimeters | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| Mean Diameter of Erythema at Site of Injection With the Antigen Mycobacterium (M.) Leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM) at Doses of 1.0 Micrograms | 20.0 | 23.3 ± 4.6 | 13.0 ± 5.9 | 14.8 ± 6.5 |
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.
| Millimeters | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| 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 | 16.0 | 20.3 ± 5.3 | 13.8 ± 6.6 | 14.3 ± 6.6 |
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.
| Millimeters | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|
| Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms | 15.1 ± 3.3 | 13.0 ± 4.6 | 9.6 ± 2.3 |
If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.
| Millimeters | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|
| Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms | 12.1 ± 5.0 | 12.2 ± 3.4 | 8.9 ± 1.4 |
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.
| Millimeters | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms | 9.0 | 20.8 ± 2.9 | 14.7 ± 5.7 | 15.0 ± 6.1 |
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.
| Millimeters | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|
| Mean Diameter of Erythema at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms | 17.8 ± 7.0 | 16.4 ± 5.1 | 13.8 ± 5.3 |
If erythema was present, it was measured in millimeters for participants in Groups C1 and C1b only, who returned to the clinic at Days 3 and 7, and at Day 28 if reactions were still present.
| Millimeters | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|---|---|
| Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD) | 20.4 ± 9.4 | 20.7 ± 8.0 | 19.3 ± 9.8 | 22.4 ± 7.1 | 18.1 ± 6.0 | 17.8 ± 4.8 | 17.6 ± 8.1 | 21.1 ± 7.0 |
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.
| Millimeters | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|---|---|
| Mean Diameter of Erythema at Site of Injection With the Antigen Purified Protein Derivative (PPD) | 18.6 ± 5.4 | 19.0 ± 6.5 | 17.8 ± 5.7 | 20.9 ± 4.6 | 16.8 ± 4.2 | 17.1 ± 4.3 | 16.4 ± 6.2 | 19.1 ± 4.2 |
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).
| Millimeters | B1 - MLSA in Healthy Non-Exposed Participants | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts |
|---|---|---|---|
| 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 | 5.0 ± 3.5 | 14.0 ± 3.2 | 10.8 ± 1.1 |
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).
| Millimeters | B1 - MLSA in Healthy Non-Exposed Participants | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts |
|---|---|---|---|
| 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 | 4.5 | 11.3 ± 3.4 | 10.3 ± 0.8 |
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).
| Millimeters | A1 - MLSA in Healthy Non-Exposed Participants |
|---|---|
| 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 | 25.0 |
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).
| Millimeters | A1 - MLSA in Healthy Non-Exposed Participants | B1 - MLSA in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|
| 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 | 20.0 | 9.4 ± 5.5 | 20.0 | 21.3 ± 2.5 | 14.4 ± 6.5 | 14.1 ± 4.7 |
If induration was present, it was measured in millimeters at Days 2 (Group A), 3 (all groups) and 7 (Groups B and C), and at Day 28 if reactions were still present (all groups).
| Millimeters | B1 - MLSA in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|
| 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 | 8.1 ± 3.4 | 16 | 16.3 ± 9.5 | 17.1 ± 6.2 | 6.4 ± 2.9 |
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).
| Millimeters | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|
| Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms | 14.8 ± 4 | 11.5 ± 5.1 | 8.3 ± 2.1 |
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).
| Millimeters | B2 - MLC in Healthy Non-Exposed Participants | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 0.1 Micrograms | 7.0 | 11.4 ± 4.0 | 11.8 ± 3.7 | 10.0 |
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).
| Millimeters | A2 - MLC in Healthy Non-Exposed Participants |
|---|---|
| Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms | 25.0 |
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).
| Millimeters | A2 - MLC in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|
| Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms | 16.5 | 9.8 ± 5.1 | 20.1 ± 1.3 | 14.2 ± 4.9 | 14.6 ± 5.4 |
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).
| Millimeters | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| Mean Diameter of Induration at Site of Injection With the Antigen M. Leprae Cell Wall Antigen (MLCwA) at Doses of 1.0 Micrograms | 9.0 ± 4.7 | 23.5 | 13.8 ± 7.5 | 10.2 ± 4.9 |
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).
| Millimeters | A1 - MLSA in Healthy Non-Exposed Participants | A2 - MLC in Healthy Non-Exposed Participants |
|---|---|---|
| Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD) | 19.3 ± 15.2 | 25.5 ± 11.0 |
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).
| Millimeters | A1 - MLSA in Healthy Non-Exposed Participants | A2 - MLC in Healthy Non-Exposed Participants | B1 - MLSA in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD) | 19.1 ± 9.7 | 20.5 ± 8.2 | 15.1 ± 5.6 | 18.8 ± 6.5 | 18.7 ± 6.3 | 21 ± 5.4 | 17.2 ± 6.0 | 20.1 ± 4.6 | 18.8 ± 6.3 | 21.0 ± 5.4 | 17.2 ± 6.0 | 20.1 ± 4.6 |
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).
| Millimeters | B1 - MLSA in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|---|---|---|---|
| Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD) | 14.0 ± 5.7 | 16.0 ± 5.6 | 18.3 ± 5.8 | 18.8 ± 6.8 | 17.0 ± 5.6 | 17.5 ± 5.6 | 18.3 ± 5.8 | 18.8 ± 6.8 | 17.0 ± 5.6 | 17.5 ± 5.6 |
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).
| Millimeters | A1 - MLSA in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | C1b - Low Dose MLSA and MLC in Healthy Contacts |
|---|---|---|---|---|
| Mean Diameter of Induration at Site of Injection With the Antigen Purified Protein Derivative (PPD) | 16.0 | 13.5 ± 0 | 8.0 | 8 |
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.
| Participants | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| Positive QuantiFERON and Induration > 0 mm | 0 | 5 | 3 | 1 |
| Negative QuantiFERON and Induration = 0 mm | 2 | 1 | 0 | 1 |
| Negative QuantiFERON and Induration > 0 mm | 0 | 0 | 0 | 0 |
| Positive QuantiFERON and Induration = 0 mm | 17 | 12 | 14 | 15 |
| Missing QuantiFERON result and/or Induration | 0 | 2 | 3 | 3 |
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.
| Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| Positive QuantiFERON and Induration > 0 mm | 4 | 5 | 2 | 0 |
| Negative QuantiFERON and Induration = 0 mm | 5 | 10 | 9 | 12 |
| Negative QuantiFERON and Induration > 0 mm | 2 | 4 | 0 | 1 |
| Positive QuantiFERON and Induration = 0 mm | 9 | 1 | 9 | 7 |
| Missing QuantiFERON result and/or Induration | 0 | 0 | 0 | 0 |
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.
| Participants | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| Positive QuantiFERON and Induration > 0 mm | 0 | 6 | 5 | 3 |
| Negative QuantiFERON and Induration = 0 mm | 3 | 1 | 0 | 1 |
| Negative QuantiFERON and Induration > 0 mm | 0 | 0 | 0 | 0 |
| Positive QuantiFERON and Induration = 0 mm | 16 | 11 | 12 | 13 |
| Missing QuantiFERON result and/or Induration | 0 | 2 | 3 | 3 |
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.
| Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| Positive QuantiFERON and Induration > 0 mm | 0 | 2 | 8 | 4 |
| Negative QuantiFERON and Induration = 0 mm | 9 | 10 | 3 | 7 |
| Negative QuantiFERON and Induration > 0 mm | 0 | 1 | 2 | 6 |
| Positive QuantiFERON and Induration = 0 mm | 11 | 7 | 7 | 3 |
| Missing QuantiFERON result and/or Induration | 0 | 0 | 0 | 0 |
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.
| Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|---|---|
| Positive QuantiFERON and Induration > 0 mm | 10 | 11 | 15 | 17 | 9 | 13 | 14 | 17 |
| Negative QuantiFERON and Induration = 0 mm | 4 | 3 | 0 | 1 | 2 | 0 | 0 | 0 |
| Negative QuantiFERON and Induration > 0 mm | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 0 |
| Positive QuantiFERON and Induration = 0 mm | 5 | 5 | 3 | 1 | 8 | 5 | 3 | 0 |
| Missing QuantiFERON result and/or Induration | 0 | 0 | 0 | 0 | 0 | 2 | 3 | 3 |
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.
| Participants | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| Pos PGL, Neg QuantiFERON and Induration = 0 mm | 1 | 0 | 0 | 0 |
| Neg PGL, Pos QuantiFERON and Induration > 0 mm | 0 | 3 | 3 | 0 |
| Pos PGL, Pos QuantiFERON and Induration > 0 mm | 0 | 2 | 0 | 1 |
| Neg PGL, Neg QuantiFERON and Induration = 0 mm | 1 | 1 | 0 | 1 |
| Neg PGL, Neg QuantiFERON and Induration = 0 mm | 0 | 0 | 0 | 0 |
| Pos PGL, Neg QuantiFERON and Induration > 0 mm | 0 | 0 | 0 | 0 |
| Neg PGL, Pos QuantiFERON and Induration > 0 mm | 4 | 6 | 11 | 13 |
| Pos PGL, Pos QuantiFERON and Induration = 0 mm | 13 | 6 | 3 | 2 |
| Missing Either Assay Result or Induration | 0 | 2 | 3 | 3 |
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.
| Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| Pos PGL, Neg QuantiFERON and Induration = 0 mm | 3 | 10 | 6 | 12 |
| Neg PGL, Pos QuantiFERON and Induration > 0 mm | 2 | 1 | 0 | 0 |
| Pos PGL, Pos QuantiFERON and Induration > 0 mm | 2 | 4 | 2 | 0 |
| Neg PGL, Neg QuantiFERON and Induration = 0 mm | 2 | 0 | 2 | 0 |
| Neg PGL, Neg QuantiFERON and Induration = 0 mm | 0 | 2 | 0 | 0 |
| Pos PGL, Neg QuantiFERON and Induration > 0 mm | 2 | 2 | 0 | 1 |
| Neg PGL, Pos QuantiFERON and Induration > 0 mm | 4 | 0 | 5 | 0 |
| Pos PGL, Pos QuantiFERON and Induration = 0 mm | 5 | 1 | 4 | 7 |
| Missing Either Assay Result or Induration | 0 | 0 | 1 | 0 |
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.
| Participants | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| Pos PGL, Neg QuantiFERON and Induration = 0 mm | 2 | 0 | 0 | 0 |
| Neg PGL, Pos QuantiFERON and Induration > 0 mm | 0 | 4 | 5 | 2 |
| Pos PGL, Pos QuantiFERON and Induration > 0 mm | 0 | 2 | 0 | 1 |
| Neg PGL, Neg QuantiFERON and Induration = 0 mm | 1 | 1 | 0 | 1 |
| Neg PGL, Neg QuantiFERON and Induration = 0 mm | 0 | 0 | 0 | 0 |
| Pos PGL, Neg QuantiFERON and Induration > 0 mm | 0 | 0 | 0 | 0 |
| Neg PGL, Pos QuantiFERON and Induration > 0 mm | 4 | 5 | 9 | 11 |
| Pos PGL, Pos QuantiFERON and Induration = 0 mm | 12 | 6 | 3 | 2 |
| Missing Either Assay Result or Induration | 0 | 2 | 3 | 3 |
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.
| Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|
| Pos PGL, Neg QuantiFERON and Induration = 0 mm | 9 | 7 | 1 | 6 |
| Neg PGL, Pos QuantiFERON and Induration > 0 mm | 0 | 0 | 5 | 1 |
| Pos PGL, Pos QuantiFERON and Induration > 0 mm | 0 | 2 | 3 | 3 |
| Neg PGL, Neg QuantiFERON and Induration = 0 mm | 0 | 3 | 2 | 1 |
| Neg PGL, Neg QuantiFERON and Induration = 0 mm | 0 | 0 | 0 | 1 |
| Pos PGL, Neg QuantiFERON and Induration > 0 mm | 0 | 0 | 2 | 5 |
| Neg PGL, Pos QuantiFERON and Induration > 0 mm | 0 | 4 | 1 | 0 |
| Pos PGL, Pos QuantiFERON and Induration = 0 mm | 11 | 3 | 6 | 3 |
| Missing Either Assay Result or Induration | 0 | 1 | 0 | 0 |
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.
| Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|---|---|
| Pos PGL, Neg QuantiFERON and Induration = 0 mm | 4 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Neg PGL, Pos QuantiFERON and Induration > 0 mm | 0 | 4 | 5 | 3 | 2 | 6 | 12 | 14 |
| Pos PGL, Pos QuantiFERON and Induration > 0 mm | 10 | 7 | 10 | 14 | 7 | 7 | 2 | 3 |
| Neg PGL, Neg QuantiFERON and Induration = 0 mm | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 0 |
| Neg PGL, Neg QuantiFERON and Induration = 0 mm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pos PGL, Neg QuantiFERON and Induration > 0 mm | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 0 |
| Neg PGL, Pos QuantiFERON and Induration > 0 mm | 0 | 1 | 3 | 0 | 2 | 4 | 2 | 0 |
| Pos PGL, Pos QuantiFERON and Induration = 0 mm | 5 | 4 | 0 | 1 | 6 | 1 | 1 | 0 |
| Missing Either Assay Result or Induration | 0 | 1 | 0 | 0 | 0 | 2 | 3 | 3 |
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A1 - MLSA in Healthy Non-Exposed Participants | — | 0/5 (0%) | 5/5 (100%) |
| A2 - MLC in Healthy Non-Exposed Participants | — | 0/5 (0%) | 4/5 (80%) |
| B1 - MLSA in Healthy Non-Exposed Participants | — | 2/45 (4.4%) | 36/45 (80%) |
| B2 - MLC in Healthy Non-Exposed Participants | — | 0/45 (0%) | 35/45 (77.8%) |
| C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | — | 0/20 (0%) | 13/20 (65%) |
| C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | — | 0/20 (0%) | 15/20 (75%) |
| C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | — | 0/20 (0%) | 19/20 (95%) |
| CI - High Dose MLSA and MLC in TB Patients | — | 0/20 (0%) | 20/20 (100%) |
| C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | — | 0/20 (0%) | 11/20 (55%) |
| C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | — | 0/20 (0%) | 16/20 (80%) |
| C1b - Low Dose MLSA and MLC in Healthy Contacts | — | 0/20 (0%) | 18/20 (90%) |
| C1b - Low Dose MLSA and MLC in TB Patients | — | 0/20 (0%) | 20/20 (100%) |
| Event | A1 - MLSA in Healthy Non-Exposed Participants | A2 - MLC in Healthy Non-Exposed Participants | B1 - MLSA in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AppendicitisInfections and infestations | 0/5 | 0/5 | 1/45 | 0/45 | 0/20 | 0/20 | 0/20 | 0/20 | 0/20 | 0/20 | 0/20 | 0/20 |
| Cerebral haemorrhageNervous system disorders | 0/5 | 0/5 | 1/45 | 0/45 | 0/20 | 0/20 | 0/20 | 0/20 | 0/20 | 0/20 | 0/20 | 0/20 |
| Event | A1 - MLSA in Healthy Non-Exposed Participants | A2 - MLC in Healthy Non-Exposed Participants | B1 - MLSA in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ErythemaSkin and subcutaneous tissue disorders | 5/5 | 4/5 | 36/45 | 34/45 | 13/20 | 15/20 | 19/20 | 20/20 | 11/20 | 16/20 | 18/20 | 20/20 |
| IndurationGeneral disorders | 5/5 | 4/5 | 34/45 | 31/45 | 12/20 | 14/20 | 18/20 | 18/20 | 9/20 | 15/20 | 17/20 | 20/20 |
| PruritisSkin and subcutaneous tissue disorders | 0/5 | 0/5 | 17/45 | 17/45 | 5/20 | 6/20 | 10/20 | 15/20 | 0/20 | 9/20 | 6/20 | 12/20 |
| PainGeneral disorders | 1/5 | 2/5 | 14/45 | 13/45 | 7/20 | 8/20 | 5/20 | 9/20 | 3/20 | 1/20 | 4/20 | 3/20 |
| UrticariaSkin and subcutaneous tissue disorders | 1/5 | 2/5 | 0/45 | 1/45 | 0/20 | 0/20 | 0/20 | 1/20 | 0/20 | 0/20 | 1/20 | 0/20 |
| BlisterSkin and subcutaneous tissue disorders | 1/5 | 0/5 | 0/45 | 4/45 | 2/20 | 0/20 | 1/20 | 1/20 | 0/20 | 0/20 | 2/20 | 0/20 |
| HaemorrhageVascular disorders | 0/5 | 0/5 | 0/45 | 0/45 | 0/20 | 0/20 | 0/20 | 0/20 | 0/20 | 0/20 | 1/20 | 0/20 |
| InfectionInfections and infestations | 0/5 | 0/5 | 0/45 | 0/45 | 0/20 | 0/20 | 0/20 | 1/20 | 0/20 | 0/20 | 1/20 | 0/20 |
| Type IV hypersensitivity reactionImmune system disorders | 0/5 | 0/5 | 0/45 | 0/45 | 0/20 | 0/20 | 0/20 | 0/20 | 0/20 | 1/20 | 0/20 | 0/20 |
| Age, Categorical(Participants) | A1 - MLSA in Healthy Non-Exposed Participants | A2 - MLC in Healthy Non-Exposed Participants | B1 - MLSA in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 13 | 10 | 0 | 0 | 0 | 4 | 0 | 1 | 4 | 1 | 33 |
| Between 18 and 65 years | 5 | 5 | 32 | 35 | 20 | 20 | 20 | 16 | 20 | 19 | 16 | 19 | 227 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | A1 - MLSA in Healthy Non-Exposed Participants | A2 - MLC in Healthy Non-Exposed Participants | B1 - MLSA in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 30.6 ± 6.4 | 29.4 ± 2.9 | 21.1 ± 5.3 | 23.1 ± 6.7 | 37.5 ± 12.3 | 32.9 ± 12.9 | 32.9 ± 11.0 | 26.0 ± 7.7 | 35.2 ± 13.1 | 39.0 ± 13.5 | 30.2 ± 12.1 | 31.1 ± 13.1 | 28.5 ± 11.3 |
| Sex: Female, Male(Participants) | A1 - MLSA in Healthy Non-Exposed Participants | A2 - MLC in Healthy Non-Exposed Participants | B1 - MLSA in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 4 | 4 | 14 | 8 | 6 | 6 | 7 | 7 | 5 | 4 | 14 | 5 | 84 |
| Male | 1 | 1 | 31 | 37 | 14 | 14 | 13 | 13 | 15 | 16 | 6 | 15 | 176 |
| Region of Enrollment(participants) | A1 - MLSA in Healthy Non-Exposed Participants | A2 - MLC in Healthy Non-Exposed Participants | B1 - MLSA in Healthy Non-Exposed Participants | B2 - MLC in Healthy Non-Exposed Participants | C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients | C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients | C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts | CI - High Dose MLSA and MLC in TB Patients | C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients | C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients | C1b - Low Dose MLSA and MLC in Healthy Contacts | C1b - Low Dose MLSA and MLC in TB Patients | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nepal | 5 | 5 | 45 | 45 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 260 |
The record gives a start of Apr 2002, a primary completion of Sep 2009 and a completion of Sep 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2010, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Allergy and Infectious Diseases (NIAID) →