Leprosy Skin Test Antigens Phase 1

NCT01920750 | Completed Phase 1

• 1 other identifier: 98-011
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Leprosy

Keywords

Leprosy, skin test, MLSA-LAM, MLCwA, diagnosis, Protocol 98-202

Outcome Measures

Primary Outcomes (2)

• Range of concentration (1, 10, and 25 micrograms/ml) responses in the two leprosy skin test antigens in the control and mock antigens

  Up to 28 days post injection

• Incidence of leprosy

  Up to 28 days post injection

Study Arms (2)

Group 2

EXPERIMENTAL

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

Biological: MLCwA; Biological: MLSA-LAM; Other: Mock Antigen

Group 1

EXPERIMENTAL

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

Biological: MLCwA; Biological: MLSA-LAM; Other: Mock Antigen

Interventions

MLCwA BIOLOGICAL

Antigen MLSA-LAM is a pellet extracted 3x followed by removal of SDS by column chromatography. Contains many of the same proteins

Group 1; Group 2

MLSA-LAM BIOLOGICAL

Antigen MLSA-LAM is derived from M. leprae extract following sonication and centrifugation, leaving the cytosol (MLSA). Contains soluble protein antigens of M. leprae

Group 1; Group 2

Mock Antigen OTHER

Physiological saline

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Related Publications (1)

• 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.

  PMID: 24874401 RESULT

MeSH Terms

Conditions

Leprosy; Disease

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: August 12, 2013
• Study Start: January 1, 1989
• Primary Completion: February 1, 1999
• Study Completion: February 1, 1999
• Last Updated: July 25, 2014

Record last verified: 2013-08