Leprosy Skin Test Antigens Phase 1
Primary Purpose
Leprosy
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MLCwA
MLSA-LAM
Mock Antigen
Sponsored by
About this trial
This is an interventional diagnostic trial for Leprosy focused on measuring Leprosy, skin test, MLSA-LAM, MLCwA, diagnosis, Protocol 98-202
Eligibility Criteria
Inclusion Criteria:
- Born in the United States (less chance of previous exposure to tuberculosis or leprosy)
- Healthy individuals who are free of any evidence of leprosy or tuberculosis by established clinical examinations
- Between the ages of 18 and 40 years old
- Females of child-bearing age (defined from the period of menarche to menopause, usually between the ages of 15 to 45), certified as not pregnant (as determined by a pregnancy test performed within 7 days prior to admission into the study)
- Agreement to participate in the study after verbal explanation by the physician and nurses and signing of an informed consent form.
- Weight greater than 100 lbs. (female) and.140 lbs. (male)
- No known hypersensitivities or allergies
- Negative tuberculin skin test (as determined by skin tests performed 3 weeks prior to study entry)
Exclusion Criteria:
- Pregnant or lactating females
- Oral corticosteroid treatment
- Chronic illness
- Immunosuppressive condition
- Tuberculosis
- Leprosy
- Age <18 or >40
- Weight <100 lbs. (female) or <140 lbs. (male)
- Positive tuberculin skin test
- Extensive travel (2-3 trips/year) in leprosy/tuberculosis endemic regions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 2
Group 1
Arm Description
5 subjects will receive d single 0.1 ml intracutaneous injections of 3 titrated doses (1, 10, and 25 grams/ml) of MLCwA and one of mock antigen equally in two arms
5 subjects received single 0.1 ml intracutaneous injections of 3 titrated doses (1, 10, and 25 grams/ml) of MLSA-LAM and one of mock antigen equally in two arms
Outcomes
Primary Outcome Measures
Range of concentration (1, 10, and 25 micrograms/ml) responses in the two leprosy skin test antigens in the control and mock antigens
Incidence of leprosy
Secondary Outcome Measures
Full Information
NCT ID
NCT01920750
First Posted
July 25, 2013
Last Updated
July 24, 2014
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT01920750
Brief Title
Leprosy Skin Test Antigens Phase 1
Official Title
Phase I Study to Evaluate New Leprosy Skin Test Antigens: MLSA-LAM and MLCwA
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 1989 (undefined)
Primary Completion Date
February 1999 (Actual)
Study Completion Date
February 1999 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
Brief Summary
This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the immunologically active proteins from the soluble/cytosol and insoluble cell wall of Mycobacterium leprae. The overall objective is to generate new leprosy skin-test antigens, equivalent to tuberculin-PPD in the tuberculosis context, to be used (I) for the early diagnosis of leprosy; and (ii) as epidemiological tools to measure the incidence of disease. Evaluating new leprosy skin test antigens may provide a better way to diagnose leprosy in its early stages of infection. With the early administration of drug therapy, infected individuals can then be cured of this disease before nerve damage occurs or nodules (lepromas) start to develop on the skin. Ten healthy, leprosy-unexposed, tuberculin-negative volunteers, 18-40 years old, from within the staff of the Mycobacteria Research Laboratories, Department of Microbiology, Colorado State University, Fort Collins, Colorado, will be selected.
Detailed Description
This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the immunologically active proteins from the soluble/cytosol and insoluble cell wall of Mycobacterium leprae. The overall objective is to generate new leprosy skin-test antigens, equivalent to tuberculin-PPD in the tuberculosis context, to be used (I) for the early diagnosis of leprosy; and (ii) as epidemiological tools to measure the incidence of disease. Evaluating new leprosy skin test antigens may provide a better way to diagnose leprosy in its early stages of infection. With the early administration of drug therapy, infected individuals can then be cured of this disease before nerve damage occurs or nodules (lepromas) start to develop on the skin. Ten healthy, leprosy-unexposed, tuberculin-negative volunteers, ages 18-40 years old, from within the staff of the Mycobacteria Research Laboratories, Department of Microbiology, Colorado State University, Fort Collins, Colorado, will be selected for this study. The volunteers will be recruited by direct contact after placing notices in the Department of Microbiology at Colorado State University. There are approximately 40 faculty/staff/students in this population and all are routinely tested (PPD skin-testing or chest X-ray) by the staff at the Hartshorn Health Service Center in the context of the Department's tuberculosis research. Five individuals will be selected for testing MLSA-LAM and five will receive MLCwA. Each will receive single 0.1 ml intracutaneous injections of three titrated doses (1, 10 and 25 )lg/ml) of the skin-test antigen, one of mock antigen (i.e., physiological saline), and one of control antigen (the product now in use; Rees MLSA, 10 )lg), divided equally between the subject's two arms. Results will be recorded at 15 min, 48 h, 72 h, and 28 days post-injection. The test dose will be administered with a sterile1 ml syringe calibrated in tenths and fitted with a sterile, one-half inch, 26 or 27 gauge needle. The rubber stopper of the vial will be wiped with a sterile piece of cotton moistened with alcohol and allowed to dry.It is expected that all concentrations of the two leprosy skin test antigens will evoke similar negative responses. If so, all three concentrations will be used for subsequent studies. This protocol is linked to study 98-202.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leprosy
Keywords
Leprosy, skin test, MLSA-LAM, MLCwA, diagnosis, Protocol 98-202
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 2
Arm Type
Experimental
Arm Description
5 subjects will receive d single 0.1 ml intracutaneous injections of 3 titrated doses (1, 10, and 25 grams/ml) of MLCwA and one of mock antigen equally in two arms
Arm Title
Group 1
Arm Type
Experimental
Arm Description
5 subjects received single 0.1 ml intracutaneous injections of 3 titrated doses (1, 10, and 25 grams/ml) of MLSA-LAM and one of mock antigen equally in two arms
Intervention Type
Biological
Intervention Name(s)
MLCwA
Intervention Description
Antigen MLSA-LAM is a pellet extracted 3x followed by removal of SDS by column chromatography. Contains many of the same proteins
Intervention Type
Biological
Intervention Name(s)
MLSA-LAM
Intervention Description
Antigen MLSA-LAM is derived from M. leprae extract following sonication and centrifugation, leaving the cytosol (MLSA). Contains soluble protein antigens of M. leprae
Intervention Type
Other
Intervention Name(s)
Mock Antigen
Intervention Description
Physiological saline
Primary Outcome Measure Information:
Title
Range of concentration (1, 10, and 25 micrograms/ml) responses in the two leprosy skin test antigens in the control and mock antigens
Time Frame
Up to 28 days post injection
Title
Incidence of leprosy
Time Frame
Up to 28 days post injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Born in the United States (less chance of previous exposure to tuberculosis or leprosy)
Healthy individuals who are free of any evidence of leprosy or tuberculosis by established clinical examinations
Between the ages of 18 and 40 years old
Females of child-bearing age (defined from the period of menarche to menopause, usually between the ages of 15 to 45), certified as not pregnant (as determined by a pregnancy test performed within 7 days prior to admission into the study)
Agreement to participate in the study after verbal explanation by the physician and nurses and signing of an informed consent form.
Weight greater than 100 lbs. (female) and.140 lbs. (male)
No known hypersensitivities or allergies
Negative tuberculin skin test (as determined by skin tests performed 3 weeks prior to study entry)
Exclusion Criteria:
Pregnant or lactating females
Oral corticosteroid treatment
Chronic illness
Immunosuppressive condition
Tuberculosis
Leprosy
Age <18 or >40
Weight <100 lbs. (female) or <140 lbs. (male)
Positive tuberculin skin test
Extensive travel (2-3 trips/year) in leprosy/tuberculosis endemic regions
12. IPD Sharing Statement
Citations:
PubMed Identifier
24874401
Citation
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. Erratum In: PLoS Negl Trop Dis. 2014 Jul;8(7):e3065. Kunwar, Chatra B [corrected to Kunwar, Chhatra B].
Results Reference
result
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Leprosy Skin Test Antigens Phase 1
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