- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01920750
Leprosy Skin Test Antigens Phase 1
July 24, 2014 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
Phase I Study to Evaluate New Leprosy Skin Test Antigens: MLSA-LAM and MLCwA
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 2
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
|
Antigen MLSA-LAM is a pellet extracted 3x followed by removal of SDS by column chromatography.
Contains many of the same proteins
Antigen MLSA-LAM is derived from M. leprae extract following sonication and centrifugation, leaving the cytosol (MLSA).
Contains soluble protein antigens of M. leprae
Physiological saline
|
Experimental: Group 1
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
|
Antigen MLSA-LAM is a pellet extracted 3x followed by removal of SDS by column chromatography.
Contains many of the same proteins
Antigen MLSA-LAM is derived from M. leprae extract following sonication and centrifugation, leaving the cytosol (MLSA).
Contains soluble protein antigens of M. leprae
Physiological saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Up to 28 days post injection
|
Incidence of leprosy
Time Frame: Up to 28 days post injection
|
Up to 28 days post injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1989
Primary Completion (Actual)
February 1, 1999
Study Completion (Actual)
February 1, 1999
Study Registration Dates
First Submitted
July 25, 2013
First Submitted That Met QC Criteria
August 8, 2013
First Posted (Estimate)
August 12, 2013
Study Record Updates
Last Update Posted (Estimate)
July 25, 2014
Last Update Submitted That Met QC Criteria
July 24, 2014
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 98-011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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