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Leprosy Skin Test Antigens Phase 1

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ClinicalTrials.gov Identifier: NCT01920750
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Tracking Information
First Submitted Date  ICMJE July 25, 2013
First Posted Date  ICMJE August 12, 2013
Last Update Posted Date July 25, 2014
Study Start Date  ICMJE January 1989
Actual Primary Completion Date February 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2013)
  • 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 ]
  • Incidence of leprosy [ Time Frame: Up to 28 days post injection ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01920750 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Leprosy Skin Test Antigens Phase 1
Official Title  ICMJE Phase I Study to Evaluate New Leprosy Skin Test Antigens: MLSA-LAM and MLCwA
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Leprosy
Intervention  ICMJE
  • Biological: MLCwA
    Antigen MLSA-LAM is a pellet extracted 3x followed by removal of SDS by column chromatography. Contains many of the same proteins
  • Biological: MLSA-LAM
    Antigen MLSA-LAM is derived from M. leprae extract following sonication and centrifugation, leaving the cytosol (MLSA). Contains soluble protein antigens of M. leprae
  • Other: Mock Antigen
    Physiological saline
Study Arms  ICMJE
  • 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
    Interventions:
    • Biological: MLCwA
    • Biological: MLSA-LAM
    • Other: Mock Antigen
  • 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
    Interventions:
    • Biological: MLCwA
    • Biological: MLSA-LAM
    • Other: Mock Antigen
Publications * 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].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2013)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 1999
Actual Primary Completion Date February 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920750
Other Study ID Numbers  ICMJE 98-011
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP