Leprosy Skin Test Antigens Trial
Condition: Leprosy
MeSH terms: Leprosy
Intervention: Tuberculin, Purified Protein Derivative; MLSA-LAM; MLCwA; Tuberculin, Purified Protein Derivative; Placebo
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: leprosy, Mycobacterium leprae, Hansen's Disease, skin test, Nepal

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

        All Subjects

          -  Between the ages of 18 and 60 years old

          -  Male or female; not less than 30 percent for one gender

          -  Agree to participate in the study after verbal explanation by the physician and
             nurses, as indicated by signing an informed consent form

          -  Weight greater than 30 Kg (female) and 38 Kg (male)

          -  Available for skin test readings

          -  Nepali residents, including expatriates from India

        Healthy, Non-Contacts

          -  Healthy (determined by history and physical examination)

          -  No household or working contact with tuberculosis or leprosy patients

        Contacts of Leprosy Patients

          -  Healthy (determined by history and physical examination)

          -  Household contact of a person with leprosy for at least 6 months duration, and within
             6 months of this study, or a person professionally exposed to leprosy for at least 5
             years duration, and within 6 months of this study

        Persons with Leprosy

          -  Having one or more of the following symptoms:

               1. Hypopigmented or erythematous skin lesion(s) with definite loss of sensation

               2. Damage to the peripheral nerves as demonstrated by palpable thickening with or
                  without impairment of sensation and/or weakness of the muscles of hands, feet or
                  face

               3. Presence of acid-fast bacilli in slit skin smears

               4. Histological changes diagnostic of leprosy in skin biopsy

          -  Receiving standard multi drug treatment for leprosy or completed treatment for leprosy
             no more than 4 years prior to study enrollment

        Persons with Tuberculosis

          -  Having active tuberculosis as defined by one of the following:

               1. Extra-pulmonary tuberculosis if confirmed by culture

               2. Pulmonary tuberculosis, defined as:

          -  Having a history of a productive cough of more than 3 weeks duration that may be
             accompanied by night sweats, loss of appetite, haemoptysis, weight loss, chest pain,
             or shortness of breath, and

          -  Having one or more of the following diagnostic criteria:

          -  Sputum smear-positive, defined as one or more of the following: at least 2 of 3
             successive sputum samples positive for acid-fast bacilli by microscopy; or at least
             one sputum specimen positive and x-ray abnormalities consistent with pulmonary
             tuberculosis; or at least one positive sputum specimen that is culture positive for
             Mycobacterium tuberculosis

          -  Sputum smear-negative, defined as three sputum specimens negative for acid-fast
             bacilli but with x-ray evidence consistent with pulmonary tuberculosis and that does
             not clear with non-tuberculosis antibiotics; or three sputum samples negative for
             acid-fast bacilli by microscopy but culture positive for Mycobacterium tuberculosis

          -  Completed the intensive phase of chemotherapy for tuberculosis, but still undergoing
             the continuation phase of therapy

        Exclusion Criteria:

        All subjects

          -  Pregnant (as determined by a urine pregnancy test performed on females of
             child-bearing age on Day 0, prior to admission into the study) or lactating females

          -  Currently on oral corticosteroid or other immunosuppressive treatment

          -  Cancer, diabetes, or other chronic illness

          -  Extra-pulmonary tuberculosis not confirmed by culture

          -  Known hypersensitivities or allergies

          -  Expatriates other than those from India

          -  Participation in an earlier stage of this study

          -  Concurrent participation in another clinical trial

        Healthy, Non-Contacts

          -  History of treated tuberculosis or leprosy

          -  Clinical signs of leprosy or tuberculosis

          -  Known contact with persons with leprosy or tuberculosis

        Healthy Contacts of Leprosy Patients

          -  History of treated tuberculosis or leprosy

          -  Clinical signs of leprosy or tuberculosis

        Persons with Leprosy

          -  Leprosy patients in reversal reaction or erythema nodosum leprosum (ENL) reaction or
             those being treated with corticosteroids or thalidomide for these conditions

          -  History of treated tuberculosis

          -  Clinical signs of tuberculosis

          -  Completed full course of standard multidrug treatment (MDT) for leprosy more than 4
             years prior to study enrollment

        Persons with Tuberculosis

          -  History of treated leprosy

          -  Clinical signs of leprosy

          -  Completed full course of standard tuberculosis treatment

          -  Known contact with leprosy patients